Step by Step for CRCs and CRAs

Step by Step for CRCs and
CRAs
TM
InForm ITM
Release 4.6 SP3
Part number: DC-INF46-005-030
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Contents
About this guide
ix
Overview of this guide ......................................................................................................................................................... x
Audience ................................................................................................................................................................... x
Prerequisites.............................................................................................................................................................. x
Related information ............................................................................................................................................................. xi
Documentation ....................................................................................................................................................... xi
Training .................................................................................................................................................................. xiii
If you need assistance........................................................................................................................................................ xiv
Chapter 1 InForm overview
1
About the InForm application ........................................................................................................................................... 2
InForm users ......................................................................................................................................................................... 3
InForm system configuration ............................................................................................................................................. 4
Getting help ........................................................................................................................................................................... 5
Chapter 2 Logging on and logging off
7
Logging on to the InForm application ............................................................................................................................. 8
If you get an "Inactive user" message when you log on ................................................................................. 10
If you are automatically logged off ..................................................................................................................... 10
Changing your password ................................................................................................................................................... 11
Guidelines for choosing a password .................................................................................................................. 11
Passwords and your study .................................................................................................................................... 11
Changing your password ...................................................................................................................................... 11
About password recovery.................................................................................................................................................. 13
Setting up password recovery information ....................................................................................................... 13
Recovering your password ................................................................................................................................... 14
Logging off........................................................................................................................................................................... 16
Chapter 3 Navigating
17
Overview: InForm user interface ..................................................................................................................................... 18
Icons ...................................................................................................................................................................................... 20
Audit trail icons ...................................................................................................................................................... 20
Comment icons ...................................................................................................................................................... 20
Form navigation icon ............................................................................................................................................ 21
Freezing and locking icons .................................................................................................................................. 21
Query icons............................................................................................................................................................. 21
Patient navigation icons........................................................................................................................................ 22
Required item symbol ........................................................................................................................................... 22
Reset value icon ..................................................................................................................................................... 22
Select all checkboxes icon .................................................................................................................................... 23
Status indicator icon on form tab ....................................................................................................................... 23
Signature icons ....................................................................................................................................................... 23
Source verification icon ........................................................................................................................................ 23
Visit and form status icons (traffic lights) ......................................................................................................... 24
Flag on status icon................................................................................................................................................. 25
Document window ............................................................................................................................................................. 26
Page indexer control ........................................................................................................................................................... 27
Form indexer control ......................................................................................................................................................... 28
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Contents
Select Action list.................................................................................................................................................................. 29
Links ...................................................................................................................................................................................... 30
Using navigation shortcuts ................................................................................................................................................ 31
Most recently used pages ..................................................................................................................................... 31
Home page Go controls ....................................................................................................................................... 31
Navigation modes.................................................................................................................................................. 32
Finding a patient by patient number .................................................................................................................. 38
Patient ordering ..................................................................................................................................................... 38
Chapter 4 Taking a quick tour
41
Overview: Taking a quick tour ......................................................................................................................................... 42
Visiting CRC pages ............................................................................................................................................................. 43
Starting the tour: User mmeyer ........................................................................................................................... 43
Screening Log ......................................................................................................................................................... 44
Case Books List ..................................................................................................................................................... 46
Time and Events Schedule .................................................................................................................................. 47
Case Report Forms ............................................................................................................................................... 48
Form views ............................................................................................................................................................. 50
Patient visit information ....................................................................................................................................... 54
Form item details ................................................................................................................................................... 54
Query Listing .......................................................................................................................................................... 61
Study documentation ............................................................................................................................................ 62
Online help ............................................................................................................................................................. 66
Logging off ............................................................................................................................................................. 66
Visiting CRA pages ............................................................................................................................................................. 68
Starting the tour: User mlynch ............................................................................................................................ 68
Case Books List ..................................................................................................................................................... 69
Time and Events schedule ................................................................................................................................... 70
Source verification and monitoring screens...................................................................................................... 71
Logging off ............................................................................................................................................................. 79
Chapter 5 Screening
81
Overview: Screening........................................................................................................................................................... 82
Accessing candidate information ..................................................................................................................................... 83
Screening a study candidate .............................................................................................................................................. 84
What to do if........................................................................................................................................................................ 86
Submitting results in a screening failure ............................................................................................................ 86
Chapter 6 Enrolling
87
Overview: Enrolling ........................................................................................................................................................... 88
Enrolling a study candidate ............................................................................................................................................... 89
What to do if........................................................................................................................................................................ 92
Enrollment data is missing................................................................................................................................... 92
Candidate does not meet study criteria.............................................................................................................. 96
You do not want to enroll an eligible patient ................................................................................................... 97
Chapter 7 Entering form data
99
Overview: Entering form data........................................................................................................................................ 100
Form types ............................................................................................................................................................ 100
Item types ............................................................................................................................................................. 100
Data-entry controls ............................................................................................................................................. 101
Entering form data ........................................................................................................................................................... 103
Form submitted successfully messages ......................................................................................................................... 104
Entering a form comment............................................................................................................................................... 105
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Step by Step for CRCs and CRAs
Entering a comment on a form item ............................................................................................................... 105
Entering a comment on a form ........................................................................................................................ 106
Associating forms ............................................................................................................................................................. 107
Creating an association ....................................................................................................................................... 107
Adding an unscheduled visit ........................................................................................................................................... 109
What to do if...................................................................................................................................................................... 110
You find a data-entry error after submitting .................................................................................................. 110
Complete data is unavailable ............................................................................................................................. 111
A query is generated ............................................................................................................................................ 111
An item is inapplicable, unknown, or not done ............................................................................................. 112
A form is not applicable, unknown, or not done .......................................................................................... 113
An item is not editable or visible ...................................................................................................................... 113
Chapter 8 Updating form data
115
Overview: Updating form data....................................................................................................................................... 116
Data Value(s) page .............................................................................................................................................. 117
Audit trail .............................................................................................................................................................. 117
Updating form data .......................................................................................................................................................... 120
Clearing data ...................................................................................................................................................................... 124
Implications of clearing data ............................................................................................................................. 124
Clearing data from an item ................................................................................................................................ 124
Clearing data from a form.................................................................................................................................. 125
Deleting or undeleting an itemset .................................................................................................................................. 126
Deleting an itemset.............................................................................................................................................. 126
Undeleting an itemset ......................................................................................................................................... 128
What to do if...................................................................................................................................................................... 131
The new data item value results in a query ..................................................................................................... 131
Chapter 9 Answering queries
133
Overview: Answering queries ......................................................................................................................................... 134
Query status .......................................................................................................................................................... 134
Appearance of items with queries .................................................................................................................... 134
Query Listing ........................................................................................................................................................ 134
Queries page ......................................................................................................................................................... 136
Ways to answer queries ...................................................................................................................................... 136
Answering a query ............................................................................................................................................................ 138
Changing the data value of the item................................................................................................................. 138
Submitting answering text .................................................................................................................................. 140
What to do if...................................................................................................................................................................... 143
The new data value results in another query .................................................................................................. 143
A query conflict occurs....................................................................................................................................... 143
Chapter 10 Indicating source verification readiness
145
Overview: Indicating that a form is ready for source verification ........................................................................... 146
Marking forms SV Ready or Not SV Ready ................................................................................................................ 147
Chapter 11 Performing source verification
149
About performing source verification........................................................................................................................... 150
Online source verification ............................................................................................................................................... 151
Source verifying data on an online form ...................................................................................................................... 152
Ways to access the source verification view of a form .............................................................................................. 154
Accessing the form from a case book ........................................................................................................................... 155
Filtering for SV status in the Time and Events Schedule ............................................................................ 156
Accessing the form from the Source Verification Listing page................................................................................ 158
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Contents
Filtering the Source Verification listing ........................................................................................................... 158
Freezing or locking while monitoring ........................................................................................................................... 163
Source verifying data from a printed listing ................................................................................................................. 165
Printing an SV Report for offline verification................................................................................................ 165
The Source Verification Listing page ............................................................................................................................ 167
Source verification states ................................................................................................................................................. 169
What to do if...................................................................................................................................................................... 170
A form changes after source verification is complete................................................................................... 170
Chapter 12 Issuing queries
171
Overview: Issuing queries ............................................................................................................................................... 172
Automatic and manual queries.......................................................................................................................... 172
Query states .......................................................................................................................................................... 172
Issuing a query ................................................................................................................................................................... 173
Opening a candidate query.............................................................................................................................................. 178
Deleting a candidate query .............................................................................................................................................. 181
Navigating between queries and CRFs ......................................................................................................................... 184
What to do if...................................................................................................................................................................... 185
A query conflict occurs....................................................................................................................................... 185
You expect to see a query, but it is not there ................................................................................................. 185
Chapter 13 Closing queries
187
Overview: Closing queries............................................................................................................................................... 188
Closing queries .................................................................................................................................................................. 189
Finding answered queries ................................................................................................................................... 189
Closing the query ................................................................................................................................................. 190
How queries appear to sponsor users ........................................................................................................................... 192
Opened queries .................................................................................................................................................... 192
Answered queries................................................................................................................................................. 192
What to do if...................................................................................................................................................................... 193
The answer to a query is unacceptable ............................................................................................................ 193
A query conflict occurs....................................................................................................................................... 193
Chapter 14 Working with multiple queries
195
Overview: Working with multiple queries.................................................................................................................... 196
Closing or reissuing a set of answered queries ............................................................................................................ 197
Opening or deleting a set of candidate queries ........................................................................................................... 200
Chapter 15 Freezing, unfreezing, locking, and unlocking
203
Overview: Freezing and locking ..................................................................................................................................... 204
Freezing and locking icons ................................................................................................................................ 205
Freezing, locking, and synchronization ........................................................................................................... 205
Freezing or locking a form .............................................................................................................................................. 206
Freezing or locking several forms at once .................................................................................................................... 208
All forms in a visit ............................................................................................................................................... 208
Selected repeating form instances..................................................................................................................... 209
While monitoring................................................................................................................................................. 211
Freezing or locking a case book ..................................................................................................................................... 213
Freezing or locking with synchronization .................................................................................................................... 214
What to do if...................................................................................................................................................................... 216
Data changes after freezing or locking ............................................................................................................ 216
Chapter 16 Signing forms
217
Overview: Signing forms ................................................................................................................................................. 218
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InForm 4.6 SP3
Step by Step for CRCs and CRAs
Significance of a signature.................................................................................................................................. 218
Form and case book signatures......................................................................................................................... 218
List of required signatures.................................................................................................................................. 219
Signature groups .................................................................................................................................................. 220
Invalidation of signature by data update or query ......................................................................................... 220
Signing a CRF or case book ............................................................................................................................................ 222
Viewing signature status .................................................................................................................................................. 226
Viewing signature details ................................................................................................................................................. 228
What to do if...................................................................................................................................................................... 229
A form changes after signature ......................................................................................................................... 229
Your signature fails processing ......................................................................................................................... 229
Chapter 17 Printing
231
Printing a CRF................................................................................................................................................................... 232
Chapter 18 Generating data listings
235
Overview: Data listings .................................................................................................................................................... 236
Generating listings ............................................................................................................................................................ 237
Creating a new listing .......................................................................................................................................... 237
Saving a listing specification .............................................................................................................................. 240
Opening a saved listing specification ............................................................................................................... 240
Canceling a listing ................................................................................................................................................ 240
Deleting a listing .................................................................................................................................................. 242
Navigating from a listing to the source form ................................................................................................. 243
Customizing a listing ........................................................................................................................................... 243
What to do if...................................................................................................................................................................... 244
You cannot download a listing.......................................................................................................................... 244
Your session times out before a listing completes ........................................................................................ 244
Chapter 19 Using study documentation
245
Overview: Using study documentation......................................................................................................................... 246
Viewing study documentation ........................................................................................................................................ 247
Displaying help for a form .............................................................................................................................................. 248
Working with FAQs ......................................................................................................................................................... 250
Adding a FAQ...................................................................................................................................................... 250
Editing a FAQ ................................................................................................................................................... 252
What to do if...................................................................................................................................................................... 255
Certain forms or items always cause confusion ............................................................................................. 255
Chapter 20 Using InForm online help
257
Displaying online help ..................................................................................................................................................... 258
Navigating InForm online help ...................................................................................................................................... 259
Using the Table of Contents ............................................................................................................................. 259
Using the Index.................................................................................................................................................... 260
Using the Search tool .......................................................................................................................................... 261
Using other links .................................................................................................................................................. 262
Chapter 21 Synchronizing a trial
265
Overview: Synchronizing a trial ..................................................................................................................................... 266
Data conflict messages on comments ........................................................................................................................... 267
What is synchronizing? .................................................................................................................................................... 270
Before you can synchronize ............................................................................................................................................ 271
Ways to synchronize......................................................................................................................................................... 272
About conflicts .................................................................................................................................................................. 273
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Contents
How a conflict could occur ............................................................................................................................... 273
How the InForm Unplugged software handles conflicts ............................................................................. 273
Synchronizing a trial manually ........................................................................................................................................ 275
Reasons to synchronize manually ..................................................................................................................... 275
Using the Sync Message Exchange tool ....................................................................................................................... 276
Before you can use the Sync Message Exchange tool .................................................................................. 276
Synchronizing with the Sync Message Exchange tool .................................................................................. 276
Ways to synchronize manually ....................................................................................................................................... 279
Synchronizing from within InForm Unplugged ......................................................................................................... 280
Transferring data as files .................................................................................................................................................. 281
Before you can transfer by file .......................................................................................................................... 281
Transferring data to or from the trial............................................................................................................... 281
Viewing synchronization status information ............................................................................................................... 284
Viewing connection status details .................................................................................................................................. 285
Viewing the log summary................................................................................................................................... 285
Viewing synchronization log details ................................................................................................................. 286
Viewing details about a specific transaction batch ........................................................................................ 286
Viewing the XML listing of a transaction batch ............................................................................................ 287
Resolving conflicts ............................................................................................................................................................ 289
Resolving conflicting patient data..................................................................................................................... 289
Resolving query conflicts ................................................................................................................................... 291
Resolving study version conflicts ..................................................................................................................... 297
What to do if...................................................................................................................................................................... 301
You have problems during data exchange ...................................................................................................... 301
Chapter 22 Transferring patients
303
Overview: Patient record transfer .................................................................................................................................. 304
Audit history and patient record transfer archive .......................................................................................... 304
Patient record transfer flow ............................................................................................................................... 304
Patient status and record transfer ..................................................................................................................... 306
Patient number conflicts .................................................................................................................................... 307
Patient initials and DOB conflicts .................................................................................................................... 307
Patient transfer and study version .................................................................................................................... 307
Who can transfer patients? ................................................................................................................................ 308
How to transfer patients .................................................................................................................................................. 309
Transferring one patient at a time.................................................................................................................................. 310
If the current site is at a lower study version than the destination site ...................................................... 313
If the current site is at a higher study version than all other sites............................................................... 313
If the InForm application finds a duplicate patient number at the destination site ................................ 313
Viewing transferred patients ........................................................................................................................................... 315
Viewing the patient transfer audit trail .......................................................................................................................... 317
Viewing a patient archive ................................................................................................................................................ 320
Contents of a patient archive .......................................................................................................................................... 323
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Glossary
325
Index
329
InForm 4.6 SP3
About this guide
In this preface
Overview of this guide .......................................................................................................................... x
Related information .............................................................................................................................. xi
If you need assistance ......................................................................................................................... xiv
InForm 4.6 SP3
ix
About this guide
Overview of this guide
The Step by Step for CRCs and CRAs Guide describes how to use the InForm application to:
•
Screen and enroll patients.
•
Enter, update, and monitor clinical data.
•
Enter and respond to queries.
•
Run trial management reports and clinical data listings.
Audience
This manual is for Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs),
and other clinical trial professionals who enter and update subject data, audit and query the data
after entry, and sign entry forms.
Prerequisites
You should have experience with relevant operating systems.
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InForm 4.6 SP3
Step by Step for CRCs and CRAs
Related information
Documentation
All documentation is available from the Phase Forward Download Center.
Item
Description
Release Notes
The Release Notes document describes enhancements introduced and problems
fixed in the current release, upgrade considerations, release history, and other
late-breaking information.
Known Issues
The Known Issues document provides detailed information about the known
issues in this release, along with workarounds, if available.
Note: The most current list of known issues is available on the Phase Forward
Extranet.
To sign in to the Extranet, go to www.phaseforward.com and click Customer
Login. Enter your email address and password, and navigate to the Known
Issues section. Select a product, and then enter your search criteria.
Installation and
Configuration
The Installation and Configuration guide describes how to install the software and
configure the environment for the InForm application and Cognos 8 Business
Intelligence.
This document is also available from the Documentation CD.
Setting Up a Trial
with InForm
Architect and
MedML
The Setting Up a Trial with InForm Architect and MedML Guide describes how to
design and implement trials in the InForm application using the InForm
Architect application.
Step by Step for
CRCs and CRAs
The Step by Step for CRCs and CRAs Guide describes how to use the InForm
application to:
This document is also available from the Documentation CD.
•
Screen and enroll patients.
•
Enter, update, and monitor clinical data.
•
Enter and respond to queries.
•
Run trial management reports and clinical data listings.
This document is also available from the Documentation CD and the user
interface.
InForm 4.6 SP3
xi
About this guide
Item
Description
Reporting and
Analysis Guide
The Reporting and Analysis Guide provides an overview of the Reporting and
Analysis module. It includes a brief overview of the Reporting and Analysis
interface, illustrates how to access the Ad Hoc Reporting feature, and describes
the study management and clinical data packages available for reporting. It also
provides detailed descriptions of each standard report that is included with your
installation.
This document is also available from the Documentation CD and the user
interface.
InForm Utilities
Guide
The InForm Utilities Guide provides information about and step-by-step
instructions for using the following utilities:
•
PFConsole utility
•
MedML Installer utility
•
InForm Data Import utility
•
InForm Data Export utility
•
InForm Performance Monitor utility
•
InForm Report Folder Maintenance utility
This document is also available from the Documentation CD.
Reporting Database The Reporting Database Schema Guide describes the InForm reporting database
Schema
schema.
This document is also available from the Documentation CD.
Portal
Administration
Guide
The Portal Administration Guide provides step-by-step instructions for setting up
the InForm Portal software, and configuring and managing the InForm Portal
application.
This document is also available from the Documentation CD.
Online Help
The online Help describes how to use and administer the InForm application.
This document is available only from the user interface.
InForm
Architect online
Help
The InForm Architect online Help describes how to design and implement trials
in the InForm application using the InForm Architect application.
This document is available only from the user interface.
MedML Installer The MedML Installer utility online Help provides information about, and
utility online
step-by-step instructions for using, the MedML Installer utility, which is used to
Help
load XML that defines study components into the InForm database.
This guide also provides reference information for the MedML elements and
scripting objects that are used to import and export data to and from the
InForm application, as well as sample data import XML.
This document is available only from the user interface.
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Item
Description
InForm Data
Export utility
online Help
The InForm Data Export utility online Help provides information about and
step-by-step instructions for using the InForm Data Export utility, which is used
to export data from the InForm application to the following output formats:
•
AutoCode.
•
Customer-defined database (CDD).
•
Name value pairs.
•
Oracle Clinical.
This document is available only from the user interface.
InForm Data
Import utility
online Help
The InForm Data Import utility online Help provides information about and
step-by-step instructions for using the InForm Data Import utility, which is used
to import data into the InForm application.
This document is available only from the user interface.
Training
For information about training offerings, please see the course catalog on our website at
http://www.phaseforward.com/support/training/ or contact Phase Forward Educational
Services at training@phaseforward.com.
InForm 4.6 SP3
xiii
About this guide
If you need assistance
If you are a Phase Forward customer with a maintenance agreement, you can contact the Global
Support Center for assistance with product issues.
Your maintenance agreement indicates the type of support you are eligible to receive and
describes how to contact Phase Forward. Additionally, the Phase Forward website lists the
toll-free support number for your product, location, and support level:
http://www.phaseforward.com/support/
In the event that our toll-free telephone service is interrupted, please use either of the following
methods to contact the Global Support Center:
•
Email
customer.support@phaseforward.com
•
Telephone
In the US:
781-902-4900
Outside the US:
+44 (0) 1628 640794
Phase Forward also provides assistance with User Management, Site Assessment, and
Provisioning. Please refer to you Master Services Agreement and individual Statement of Work
to determine if you are eligible to use these services.
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InForm 4.6 SP3
CHAPTER 1
InForm overview
In this chapter
About the InForm application ............................................................................................................. 2
InForm users ........................................................................................................................................... 3
InForm system configuration ............................................................................................................... 4
Getting help............................................................................................................................................. 5
InForm 4.6 SP3
1
Chapter 1 InForm overview
About the InForm application
The InForm application is a data collection and trial management application that uses a secure
web browser to provide access to clinical trial data and management of the clinical trial process.
Embedded within the InForm user interface is the Reporting and Analysis module, which is a
reporting application that was developed by the Cognos Corporation, and that has been
customized and integrated into the InForm application by Phase Forward. The Reporting and
Analysis module provides a library of configurable reports, predefined reports, and ad hoc
reporting and charting tools. Both clinical and operational data are available in real time from a
database that can be accessed using the Internet.
Note: You can install the InForm software without the Reporting and Analysis module if you
want to use the data collection features of the InForm application without the reporting
features.
2
InForm 4.6 SP3
Step by Step for CRCs and CRAs
InForm users
The following are examples of InForm users:
User
Description
Clinical data
manager (CDM)
A person who is responsible for preparing and maintaining a trial database
and for reviewing data.
Clinical project
manager
A person who is responsible for all aspects of one or more clinical trials or
for the entire clinical plan for a drug, device, or procedure.
Clinical research
associate (CRA)
A person who is hired by a sponsor to supervise and monitor the progress of
sites that are participating in a trial.
Also called monitor, site monitor.
Clinical research
coordinator (CRC)
An assistant to the investigator at a site.
Principal
investigator (PI)
The clinician who is responsible for treating subjects, executing the protocol
of a study at a specific site, and filling out CRFs for subjects.
Also called site coordinator, trial coordinator.
Also called clinical investigator, investigator, primary investigator.
Medical monitor
A person who designs the trial protocol and reviews data.
Site user
An InForm user, typically a CRC or PI, who performs the following tasks:
Sponsor user
InForm 4.6 SP3
•
Obtains an InForm site user name and password.
•
Screens and enrolls subjects into a trial.
•
Enters and changes clinical data in electronic case report forms.
•
Answers queries on clinical data.
•
Prepares for monitoring visits.
An InForm user, typically a CRA, CDM, or medical monitor, who performs
the following tasks:
•
Obtains an InForm sponsor user name and password.
•
Reviews clinical data queries.
•
Performs source verification.
•
Transfers subjects from one site to another.
•
Runs standard reports.
•
Creates ad hoc (custom) reports.
3
Chapter 1 InForm overview
InForm system configuration
The InForm system configuration consists of:
4
•
Browser computers.
•
Application server.
•
Database server.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Getting help
The following types of Help are available with the InForm application:
•
InForm application-specific on-line Help, created by Phase Forward.
To access the InForm application on-line Help:
•
•
In the navigation pane, select Help > InForm and Trial Reporting.
Cognos-specific on-line Help, created by Cognos.
To access the Cognos 8 on-line Help:
•
In the navigation pane, select Help > Using Reporting Tools.
An HTML page appears with links to the complete Cognos 8 Business Intelligence
documentation set.
•
From the Ad Hoc Reporting workspace, click Ad Hoc Tools Help.
The Cognos Query Studio User Guide appears. Query Studio is the Cognos tool that
provides Ad Hoc Reporting capability.
Additional help for reporting
Two additional links provide reporting help.
•
Report help—After you output any InForm Standard Report in HTML format, click the
link to open detailed page-level help. This information is included on each
Standard Report.
Report Help
•
InForm 4.6 SP3
Ad Hoc tools help—After you access Ad Hoc Reporting, click the Ad Hoc tools help link.
This link provides access to the Cognos documentation for Query Studio. Query Studio is
the Cognos application that provides Ad Hoc Reporting capability.
5
Chapter 1 InForm overview
6
InForm 4.6 SP3
CHAPTER 2
Logging on and logging off
In this chapter
Logging on to the InForm application ............................................................................................... 8
Changing your password ..................................................................................................................... 11
About password recovery ................................................................................................................... 13
Logging off ............................................................................................................................................ 16
InForm 4.6 SP3
7
Chapter 2 Logging on and logging off
Logging on to the InForm application
To log on to the InForm application:
1
Open an Internet browser.
2
Type the URL for your study, and press Enter.
The log on window appears.
8
3
Type your user name and password.
4
Click Log In.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The InForm application opens and displays the main window. The user interface displays all
of the features to which you have access, based on your roles and rights.
Your study allows a specific number of log on attempts. If you exceed this number, the system
locks you out. If this happens, you can do either of the following:
InForm 4.6 SP3
•
Use your password recovery information. For more information, see Recovering your
password (on page 14).
•
Contact your administrator to reactivate your account.
9
Chapter 2 Logging on and logging off
If you get an "Inactive user" message when you log on
If the logon screen displays a message that you are an inactive user, contact your system
administrator to activate your account. Then you can log on again and start using the InForm
application.
After the administrator activates your account, change your password and use the new password
for subsequent logons. For more information, see Changing your password (on page 11).
If you are automatically logged off
Study administrators can set a maximum inactivity period and a maximum usage period for the
trial, which require you to provide your log on credentials if either of the following occurs:
•
No activity occurs in the application for a specified period of time.
•
A session runs longer than a specified period of time, with or without activity.
If your trial includes these settings and you are automatically logged off, the logon page appears
with a message that explains what has happened.
If you receive an automatic logoff message, log on again. Any data that you are in the process of
entering when you were logged off is saved until you resubmit it.
10
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Changing your password
Guidelines for choosing a password
Use the following guidelines when you create a password:
•
Use six or more characters.
•
Do not use a word or name that can be easily guessed. For example, do not use the names of
family members.
•
Use a combination of numbers, letters, and non-alphanumeric characters.
•
Use a combination of uppercase and lowercase characters.
Note: Passwords are case-sensitive.
Passwords and your study
You can change your password at any time.Some study designs require that you change your
password in certain situations, such as:
•
Immediately after you log on for the first time.
•
After a certain amount of time has passed; for example, every 90 days.
If your study requires that you change your password, the Password page appears immediately
after you log on with your current password. The page contains a message that tells you that your
password has expired and that you must change it.
Changing your password
The first time you log on, use the password that your study administrator assigned to you. Then,
immediately after you log on, change the password.
To change your password:
1
Log on to the InForm application.
2
In the navigation pane, click your user picture or user name.
The Change Password page appears.
Note: If your study design requires you to change your password, the Change Password
page appears automatically when you log on.
InForm 4.6 SP3
11
Chapter 2 Logging on and logging off
3
4
In the Change Password section, provide the following password information:
Field
Description
Password
Your current password.
New Password
The new password to use.
Confirm New Password
The new password to use.
If this is the first time that you are changing your password, in the Password Recovery
Information section, you must provide information that will help you if you subsequently
forget your password.
Note: The password recovery feature is available only if your study has been configured
to allow it.
If you have already provided recovery information, it will appear on the page. For more
information, see About password recovery (on page 13).
5
12
Click Submit.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
About password recovery
Setting up password recovery information
On the Password page, in the Password Recovery Information section, you can specify
information (also called a password hint) that will help you remember a forgotten password.
The first time that you change your password you are also required to provide password hint
information.
Note: The password recovery feature is available only if your study has been configured to
allow it.
To specify information for a password hint:
1
In the navigation pane, click your user name.
The Change Password page appears.
2
3
InForm 4.6 SP3
In the Change Password section, do either of the following:
•
Leave the Change Password section blank to keep your current password.
•
Change your password. For more information, see Changing your password (on page
11).
Complete the Password Recovery Information section as follows:
Field
Description
E-mail address
Your email address. The InForm application sends a message
that contains a temporary password to this address.
13
Chapter 2 Logging on and logging off
4
Field
Description
Confirmation question
A question that only you can answer.
Confirmation question
response
The answer to the confirmation question.
Click Submit.
Note: You must provide the answer to the confirmation question in order to receive the email
message with the temporary password.
Recovering your password
To recover your password:
14
1
On the logon page, in the User Name field, type your user name.
2
At the bottom of the window, click the Forgot Your Password? link.
3
The Reset Your Password page appears, displaying your hint question.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
4
In the Answer field, type the information that you provided in the Confirmation Question
Response field in the Password Recovery Information section on the Password page. For
more information, see Setting up password recovery information (on page 13).
5
Click Reset Password.
A confirmation message appears, informing you that your password has been reset and
emailed to you.
6
Click Return to Log-In screen.
Note: The email has the subject Reset Password Notification. The message text
contains your temporary password.
7
Use the temporary password to log on to the InForm application.
Note: The temporary password is case-sensitive.
8
InForm 4.6 SP3
Change the temporary password, and use the new password for subsequent logons.
15
Chapter 2 Logging on and logging off
Logging off
To log off:
1
In the navigation pane, in the upper-left corner, under your user name, click Logout.
A confirmation message appears.
2
16
Click OK.
InForm 4.6 SP3
CHAPTER 3
Navigating
In this chapter
Overview: InForm user interface....................................................................................................... 18
Icons ....................................................................................................................................................... 20
Document window............................................................................................................................... 26
Page indexer control ............................................................................................................................ 27
Form indexer control ........................................................................................................................... 28
Select Action list ................................................................................................................................... 29
Links ....................................................................................................................................................... 30
Using navigation shortcuts.................................................................................................................. 31
InForm 4.6 SP3
17
Chapter 3 Navigating
Overview: InForm user interface
The InForm application windows contain three panes: the navigation pane, the content pane,
and the content-specific pane. As you move through the InForm application, the contents of the
panes vary, depending on your trial and the activities you are performing, but the purpose of
each pane stays the same.
•
18
Navigation—Contains several features that help you navigate:
•
A set of buttons and a list of recently visited pages. These controls enable you to
navigate throughout the InForm application. The buttons are always visible and do not
change, so you can jump easily from activity to activity.
•
A Find Patient search box. You can enter a patient number and navigate directly to the
information for that patient.
•
The name of the study, which appears above the personal photo or logo.
•
Content—Displays the screen for the current activity; for example, summary lists, forms,
details of queries, comments, audit trails, reports, and listings.
•
Content-specific—Displays contents that vary depending on the information in the
content pane; for example, if the content pane displays a summary list of queries, the
content-specific pane contains buttons that allow you to display one page of queries at a
time. If the content pane displays a form and you have the authority to enter form data, the
InForm 4.6 SP3
Step by Step for CRCs and CRAs
content-specific pane contains buttons that allow you to submit data or cancel data entry.
Note: When you are working with the InForm application, do not use the web browser refresh
button. This action can cause problems for the trial.
InForm 4.6 SP3
19
Chapter 3 Navigating
Icons
Icons in the InForm application let you know when more detailed information is available, and
give you access to that information. To view the detailed information that is associated with an
icon, click the icon. Additionally, icon colors provide status information.
Audit trail icons
Icon
Description
Gray icon—Appears in the far-right column of a form item.
Indicates that no subsequent changes have been made to the initial data value of
the item. Click the icon to view the audit trail for the initial entry.
In the summary view of a repeating form, an audit trail icon appears in the
far-right column of each instance of the form.
Yellow icon—Appears in the far-right column of a form item.
Indicates that changes have been made to the initial data value of the item. Click
the icon to view the audit trail for the item.
In the summary view of a repeating form, an audit trail icon appears in the
far-right column of each instance of the form.
Comment icons
Icon
Description
Gray icon:
•
In the upper-right corner of a form, indicates that there is no comment on the
form as a whole.
•
In the farthest right column of a form item, indicates that there is no comment
on the item.
To type a comment, click the icon.
Yellow icon:
•
In the upper-right corner of a form, indicates that a comment exists on the
form as a whole.
•
In the farthest right column of a form item, indicates that a comment exists on
the item.
To view or update the comment, click the icon.
20
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Form navigation icon
Icon
Description
Appears in the upper-left corner of the form. Click the icon to to the Time and
Events Schedule for the current patient.
Appears in the upper-left corner of the Data Value(s), Queries, Audit Trail and
Comment tabs. Click the icon to go to the form on which a query exists.
Freezing and locking icons
Icon
Description
In the Case Books List, next to a visit traffic light icon, indicates that at least one
started form in the visit is frozen.
In the Time and Events Schedule, next to a form traffic light icon, indicates that
the form is frozen or at least one instance of a repeating form is frozen.
In the Case Books List, next to a visit traffic light icon, indicates that at least one
started form in the visit is locked.
In the Time and Events Schedule, next to a form traffic light icon, indicates that
the form is locked or at least one instance of a repeating form is locked.
Query icons
Icon
Description
Gray icon—Appears in the far-right column of a form item without any queries
against the item. Click the icon to enter a query.
This icon appears only if you have the right to issue queries.
Yellow icon—Appears in the far-right column of a form item if a query has been
entered against the item and the query is not closed. Click the icon to view or
update the query.
Green icon—Appears in the far-right column of a form item if the item has a
history of queries.
•
For site users, indicates that there are no open queries.
•
For sponsor users, indicates that all queries have been resolved.
Click the icon to view the query history.
InForm 4.6 SP3
21
Chapter 3 Navigating
Patient navigation icons
Icon
Description
Appears in the upper-right corner of the Case Books List. Links to the Order
Patients screen. This screen enables you to change the default ordering of patients
(the order in which they were enrolled) to any order you want; for example,
alphabetically.
Appears at the top of a form, in the upper-right corner of the visit navigation bar.
Click the icon to enter visit navigation mode.
Appears at the top of a form, in the upper-right corner of the visit navigation bar.
Click the icon to enter form navigation mode.
or
Available in visit or form navigation mode. Appears at the top of a form, in the
upper-right corner of the visit navigation bar. Click the icon to toggle the behavior
of patient navigation when you navigate dynamic forms, dynamic visits, or
alternate forms.
Displays a message when the dynamic form, dynamic visit, or alternate form
for the selected patient has not been activated.
Skips patients for whom the dynamic form, dynamic visit, or alternate form
has not been activated.
Available in visit or form navigation mode. Appears at the top of a form, in the
upper-right corner of the visit navigation bar. Click the icon to exit visit or form
navigation mode.
Required item symbol
Icon
Description
Appears on a CRF in the item number column. Indicates that the item is required.
Reset value icon
Icon
Description
•
Located In the far-right column of a form item. Click the icon to clear the data
value from the item before you submit the form.
Note: If any of the items on the form are marked Hidden or Read-Only
during trial design, this icon does not appear.
•
22
Located on the Data Value(s) page (used to edit data values). Click the icon to
clear data from a form item that has previously been submitted.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Select all checkboxes icon
Icon
Description
In Summary View, appears in the upper-left corner of repeating forms. In Source
Verification mode, appears on all forms.
Click the icon to select or deselect every checkbox in the list. This icon is helpful
when you are source verifying, locking, or freezing multiple forms.
Status indicator icon on form tab
Icon
Description
Appears on a tab in the form view, to the right of the tab name. Indicates that
there is work to be done on the form.
•
•
For site users, indicates that the form

Is incomplete or

Has open queries.
For sponsor users, indicates that the form

Is incomplete or

Has one or more open queries or

Has one or more answered queries.
Signature icons
Icon
Description
The form requires at least one signature.
The form has all required signatures.
The Case Book requires at least one signature.
The Case Book has all required signatures.
Source verification icon
Icon
InForm 4.6 SP3
Description
23
Chapter 3 Navigating
Icon
Description
Appears next to traffic light icons:
•
Indicates that a form, including all instances of a repeating form, has been
source verified.
•
In the Case Books List, indicates those visits in which at least one form has
been marked source verified.
You must be in a rights group that includes the Monitor right to see this icon.
Visit and form status icons (traffic lights)
Icon
Description
No lights:
•
In the Case Books List, indicates that none of the forms in the visit have been
started.
•
In the Time and Events Schedule, indicates that a specific form has not been
started, or no instances of a repeating form have been started.
Red light:
•
In the Case Books List, indicates that at least one form in the visit has one or
more open queries.
•
In the Time and Events Schedule, indicates that a specific form has one or
more open queries, or one or more instances of a repeating form have one or
more open queries.
Yellow light:
•
In the Case Books List, indicates that at least one form in the visit has been
started and has one or more missing items.
•
In the Time and Events Schedule, indicates that a specific form has one or
more missing items, or one or more instances of a repeating form have one or
more missing items.
Red and yellow lights:
24
•
In the Case Books List, indicates that at least one form in the visit has one or
more open queries and at least one form has one or more missing items.
•
In the Time and Events Schedule, indicates that a specific form or one or
more instances repeating form has one or more open queries, or one or more
missing items.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Icon
Description
Green light:
•
In the Case Books List, indicates that all CRFs in the visit are complete with
no open queries, or have been marked as NA, ND, or UNK.
•
In the Time and Events Schedule, indicates that all items in a specific CRF or
repeating form are complete with no open queries, or have been marked as
NA, ND, or UNK.
Flag on status icon
Icon
Description
The flag icon appears on visit and form status icons (traffic lights). It is visible to
sponsor users.
InForm 4.6 SP3
•
In the Case Books list, indicates that at least one form in the visit has an
answered query.
•
In the Time and Events schedule, indicates that a specific form has an
answered query.
25
Chapter 3 Navigating
Document window
When you open a document or online help, the document window opens and displays the
following panes:
26
•
Document selection—Contains a tab for each document that you can display.
•
Table of contents (TOC)—Displays the table of contents for the study documents and
online help. While you are viewing online help, you can also display an index in this pane.
Use the contents and index to navigate to specific parts of the document that is displayed.
•
Document text—Displays the text of the open document.
•
Navigation—Contains buttons that let you navigate through the standard study documents
and online help, and close the document window.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Page indexer control
The page indexer appears on the bottom-left of the content-specific pane on some screens. The
page indexer lets you move through pages of data when the data fills more than one screen. The
following figure shows the parts of the page indexer control:
Click the appropriate arrow or select a page number from the drop-down list to use the page
indexer.
InForm 4.6 SP3
27
Chapter 3 Navigating
Form indexer control
The form indexer appears on the title bar of a form on some of the InForm screens. It lets you
move through the individual forms of a repeating form. The following figure shows the parts of
the form indexer control:
Click the appropriate arrow or select a form from the drop-down list to use the form indexer.
Note: If you are in Summary view for a repeating form, the previous and next arrows show
you the previous and next 10 instances of the form.
28
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Select Action list
The Select Action list appears, along with an Apply button, on the content-specific pane of a
CRF. This control appears next to buttons for tasks that you are most likely to perform. It
contains additional actions such as Print Preview, Mark SV Ready, Clear CRF, and Freeze Visit.
Select an action, then click Apply to use the Select Action list.
InForm 4.6 SP3
29
Chapter 3 Navigating
Links
Underlined text on an InForm screen (or in online help) indicates a link to another screen. To
jump to the other screen (or topic), click the underlined text.
For example, on the Case Books List, values in the Patient and Status columns are underlined.
Click any value in either of these columns and the appropriate Time and Events Schedule
displays.
30
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Using navigation shortcuts
Most recently used pages
In the main window, the bottom of the navigation pane shows the CRF History, which lists the
four CRFs you have visited most recently.
Click the CRF name in the CRF History list to return to the page.
Home page Go controls
Use the home page Go controls to navigate directly from your trial home page to CRFs for a
specific patient and visit.
The trial home page is the window that appears when you log on. The Go controls appear at the
bottom of the InForm window in the content-specific pane.
To use the Go controls:
InForm 4.6 SP3
1
From anywhere in the InForm application, in the navigation pane, click Home.
2
If you have access to more than one site, use the Site list to select the site.
3
From the Patient drop-down list, select the patient whose information to access.
31
Chapter 3 Navigating
4
From the Visit drop-down list select the visit in which the patient information is located.
5
Click Go.
Navigation modes
To enter the results for many patients in the same session, you can use the following alternative
navigation modes:
•
Visit mode—Displays the first CRF of the same visit for each patient as you navigate
through the list of patients.
•
Form mode—Displays the same CRF for each patient as you navigate through the list of
patients.
Note: Navigation modes are not available in unscheduled visits.
Visit and Form mode icons are located in the top-right corner of the visit navigation bar for each
CRF.
Note: Navigation modes are optional features of the InForm application. The icons appear
only if the trial is configured to enable the modes, and you have the rights to use them.
Visit navigation mode
Visit navigation mode allows you to go to the first form of the current visit for the next patient
in the Case Books List. To use this mode:
1
Go to the patient and visit from which to start. Use any of the available shortcuts, or do the
following:
a
32
In the Navigation pane, click Patients.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
2
InForm 4.6 SP3
b
In the Case Books List, click the name of the patient.
c
In the Time and Events Schedule, click the form and visit where you want to start.
Click the visit navigation mode icon (
) . The following changes occur:
33
Chapter 3 Navigating
•
The browser displays the first form in the current visit.
•
The visit navigation bar is replaced by an indication of the current patient visit and site,
and the page indexer control is available for moving through the list of patients or
selecting a specific patient.
•
The cancel navigation mode button allows you to return to normal navigation mode.
When you click the Next arrow in the page indexer control, the first form in the current visit
appears for the next patient in the Case Books List.
Dynamic visits and navigation modes
Dynamic visits are created in a trial only if certain conditions are met. For example, a trial could
include an extension visit that appears only if a user enters data on an Eligibility form that
indicates that the patient is eligible to continue. In a trial that includes dynamic visits, some Case
Books can include dynamic visits that have not been activated.
When you use the visit navigation mode in a trial that includes dynamic visits, you can choose to
have the Patient drop-down list display patient names in either of the following ways:
•
Show navigation details—The list displays all patients. If you select a patient for whom a
dynamic visit has not been activated, a message stating that the visit does not exist displays.
•
Hide navigation details—The list displays only those patients with activated dynamic
visits. Patients with inactivated dynamic visits do not appear in the list.
Click the toggle navigation details icon to select the navigation method. For more information,
see Patient navigation icons (on page 22).
34
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Form navigation mode
Form navigation mode enables you to go to the current form of the current visit for the next
patient in the Case Books List. To use this mode:
1
2
InForm 4.6 SP3
Go to the patient and form where you want to start. Use any of the available shortcuts, or do
the following:
a
In the Navigation pane, click Patients.
b
In the Case Books List, click the name of the patient.
c
In the Time and Events Schedule, click the form and visit where you want to start.
Click the form navigation mode icon (
). The following changes occur:
35
Chapter 3 Navigating
36
•
The browser displays the same form in the current visit.
•
The visit navigation bar is replaced by an indication of the current patient visit and site,
and the page indexer control is available for moving through the list of patients or
selecting a specific patient.
•
The cancel navigation mode button allows you to return to normal navigation mode.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
When you click the Next arrow in the page indexer control, the current CRF in the current visit
appears for the next patient in the Case Books List.
Dynamic forms and navigation modes
Dynamic forms are created in a trial only if certain conditions are met. For example, a trial can
include a series of forms that appear only if a patient is female. In a trial with dynamic forms, the
case books for some patients can include dynamic forms that have not been activated.
When you use the form navigation mode in a trial with dynamic forms, you can choose to have
the Patient drop-down list display patient names in either of the following ways:
•
Show navigation details - The list displays all patients. If you select a patient for whom a
dynamic form has not been activated, a message displays stating that the form does not exist.
•
Hide navigation details - The list displays only those patients with activated dynamic
forms. Patients with inactivated dynamic forms do not appear in the list.
Click the toggle navigation details icon to select the navigation method. For more information,
see Patient navigation icons (on page 22).
Alternate forms and navigation modes
Alternate forms are used to collect additional data on a patient after the visit in which such data
would usually be recorded. For example, if a sponsor decides to collect additional family history
data after a patient has completed the intake visit, he would use an alternate form.
To collect this additional data, a trial can include an alternate version of a form. The alternate
version of the form appears in the visit where the data would have been collected originally. If a
InForm 4.6 SP3
37
Chapter 3 Navigating
patient has started the original version of the form, both the original and the alternate form
appear. You enter the new data on the alternate version of the form. In a trial that includes
alternate forms, some Case Books can include alternate forms that have not been activated.
When you use the form navigation mode in a trial that includes alternate forms, the Patient
drop-down list displays patient names in either of the following ways:
•
Show navigation details—The list displays all patients. If you select a patient for whom an
alternate form has not been activated, a message displays stating that the form does not exist.
•
Hide navigation details—The list displays only those patients with activated alternate
forms. Patients with unactivated alternate forms do not appear in the list.
Click the toggle navigation details icon to select the navigation method. For more information,
see Patient navigation icons (on page 22).
Finding a patient by patient number
You can find a patient and navigate directly to the Time and Events Schedule of the patient.
To find a patient:
1
On the navigation pane, in the Find Patient field, type the patient number.
Note: Type only the patient number in the field. Do not include the initials.
2
Click Go.
The Time and Events schedule for the patient appears.
If the InForm application finds more than one patient with the same number, the content
pane displays a list of case books for all sites where a matching patient number exists. You
can click the underlined Patient or Status links to display the Time and Events schedule for
the patient.
Patient ordering
By default, the list of patients in a trial appears in the order in which the patients were enrolled.
You can change the order of patients in the Case Books list to a sequence that most closely
matches the order in which you enter or review data.
Note: The ability to change the order of patients is an optional feature of the InForm
application. The patient order icon appears only if your trial has been configured to enable
the feature, and you have the rights to use it.
The patient order icon (
) is located in the upper-right corner of the Case Books List.
Note: Check with your administrator before you change the order of patients. If you change
the order of patients, the new order appears to all users of the trial.
38
InForm 4.6 SP3
Step by Step for CRCs and CRAs
To change the order of patient case books:
1
In the navigation pane, click Patients.
2
In the Case Books List, in the upper-right corner, click the patient order icon (
).
The Order Patients screen appears.
3
Select a patient.
4
Use the navigation buttons below the patient list to move the patients.
5
Click Submit.
When you are in visit or form navigation mode, patient CRFs appear in the specified order.
InForm 4.6 SP3
39
Chapter 3 Navigating
40
InForm 4.6 SP3
CHAPTER 4
Taking a quick tour
In this chapter
Overview: Taking a quick tour ........................................................................................................... 42
Visiting CRC pages............................................................................................................................... 43
Visiting CRA pages .............................................................................................................................. 68
InForm 4.6 SP3
41
Chapter 4 Taking a quick tour
Overview: Taking a quick tour
This section leads you on a quick tour the InForm application.
This tour includes a sample trial and two hypothetical users. Each user is assigned different set of
responsibilities and rights when the trial is set up.
This tour is based on sample trial PFST45 that is shipped with your software.
This section shows the different screens that appear as the following users log on and perform
tasks that are typical of their roles in the study:
•
mmeyer, who is a CRC.
•
mlynch, who is a CRA.
Many of the features that are illustrated in the CRC examples are also available to CRAs. Actual
responsibilities can vary considerably from trial to trial. Trial administrators can customize
assignments and rights for each trial.
42
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Visiting CRC pages
Starting the tour: User mmeyer
To start this part of the tour, a user who has the user name mmeyer does the following:
1
Opens an Internet browser.
2
Enters the URL for the assigned study site.
3
On the logon page, enters mmeyer and the password.
4
Clicks Log In.
The InForm application home page for the study appears. This page is customized for each
study and can include many types of information.
The Navigation pane, on the left side of the screen, contains buttons that provide access to
the pages you will visit.
Note: When you are working with the InForm application, do not use the web browser refresh
button. This action can cause problems for the trial.
InForm 4.6 SP3
43
Chapter 4 Taking a quick tour
Screening Log
The Screening Log displays the list of study candidates who have been screened.
To display the page:
•
In the Navigation pane, click Enroll.
Note: The Enroll button provides access to both screening and enrollment activities.
Things to note
•
Screening summary information—The list of study candidates is presented in table form.
For each candidate, the list includes the screening number, patient initials, and birth and
screening dates. For patients you have attempted unsuccessfully to screen or enroll, the list
displays messages that indicate why the attempts failed. For candidates who were
successfully enrolled, the list displays the patient number. The Enrollment column indicates
enrollment status.
Symbol
Description
The patient has been screened successfully. To enroll a screened patient, click
this link, and a blank Enrollment form appears.
44
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Symbol
Description
Some screening or enrollment information has been entered for the patient,
but the patient has not been screened or enrolled successfully. The Screening
Failure or Enrollment Failure column indicates the reasons for failure. To
make additions or corrections to the Enrollment form, click the X. To make
additions or corrections to the Screening form, click the underlined screening
number for the patient.
The patient has been enrolled successfully. To display the Enrollment form,
click the checkmark.
InForm 4.6 SP3
•
Add Candidate—This button is located on the right side of the content-specific pane. To
display a blank Screening form, click Add Candidate.
•
Page indexer—The page indexer is a multi-part control that is located on the bottom left
side of the content-specific pane. By clicking different parts of the control, you can move
through the pages of the Screening Log when the list of study candidates fills more than one
page.
•
Link to screening form—Note that the screening number for the patient is underlined.
Underlined text contains a link to another form. To display the Screening form, click the
underlined number. If screening is incomplete or incorrect, you can make changes and
resubmit the form.
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Chapter 4 Taking a quick tour
Case Books List
The Case Books List summarizes the status of forms and visits for each patient and lets you
navigate to specific patients and visits. The Case Books List is a convenient place to view the log
of enrolled patients.
To display the Case Books List:
•
In the Navigation pane, click Patients.
Things to note
46
•
Highlight—A series of checkboxes let you filter the display of traffic light icons for visits
that contain forms that are started, incomplete, frozen, locked, or contain queries. Traffic
lights for visits that contain forms that match all of your selections are highlighted
•
Patient status—The Status column indicates the stage at which the patient is in the study.
•
Visit status—Each patient has one traffic light icon for each visit. The colors of the traffic
light show whether the forms for each visit are complete.
•
Links to patient visit—Each traffic light icon is a link to the patient forms for a visit.
•
Page indexer—The page indexer is a multi-part control on the bottom-left side of the
content-specific pane. By clicking different parts of the control, you can move through the
InForm 4.6 SP3
Step by Step for CRCs and CRAs
pages of the Case Books List when the list of study subjects fills more than one page.
•
Show Transferred button—This button displays a list of patients who have been
transferred into or out of the sites to which you have access.
•
Links to Time and Events Schedule—The underlined patient number and initials and the
underlined patient status indicate links to the patient’s Time and Events Schedule. To display
the schedule, click the underlined text.
Time and Events Schedule
The Time and Events Schedule is a list of forms and visits for a specific patient. This page lets
you review the status of forms and visits, and navigate to a specific form.
To display the Time and Events schedule:
1
In the Navigation pane, click Patients.
2
Click the patient number or status of the patient.
Things to note
•
InForm 4.6 SP3
Highlight—A series of checkboxes let you filter the display of traffic light icons for forms
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Chapter 4 Taking a quick tour
that are started, incomplete, frozen, locked, or contain queries. Traffic lights for forms that
match all of your selections are highlighted.
•
Visits and CRFs—The Time and Events Schedule consists of a list of visits and forms. A
traffic light icon indicates which forms must be completed at each visit.
•
Form status—Each traffic light icon indicates the state of completion of a form at a
specific visit.
•
Links to CRFs—Each traffic light also provides a link to a form; to display the form, click
the traffic light icon.
•
Command buttons—The command buttons in the content-specific pane let you perform
activities that affect the patient’s entire Case Book. For example, as a CRC you might be
assigned the right to mark a Case Book ready for source verification by clicking the
appropriate command button in the Time and Events Schedule.
Case Report Forms
Case Report Forms enable you to enter, correct, or update data for a patient visit.
Note: Case Report Forms are referred to as forms or CRFs throughout the InForm product and
documentation. Both of these terms are used interchangeably.
To display a form:
48
1
In the Navigation pane, click Patients.
2
Click the traffic light icon for the patient and visit.
3
Click the tab that identifies the form. If the form is defined as a repeating form, the form is
first displayed in summary form. If data has been entered in one or more forms, click the
traffic light icon or the number to the left of the form to see details for the visit.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Things to note
InForm 4.6 SP3
•
Patient information—Patient number and initials appear at the top-right of the form.
•
Form comment—The comment icon is located in the detail view of the form, in the
upper-right corner. It provides access to comments about the form as a whole. To enter,
display or update a comment, click the icon.
•
Tabs—Each tab represents a form that is used in the visit. A yellow exclamation point (!) on
a tab indicates that work is required on the form, such as providing missing data or
answering a query.
•
Form items—Form data items are listed in table format. Questions appear on the left. Data
entry controls that you use to answer the question appear on the right.
•
Links to form help—If your trial includes a study document that gives help on form items,
and the study document has been linked to the forms during trial setup, the question text or
form name is underlined. To display the study document help, click the underlined question
text.
•
Form item icons—On the detailed view of the form, the far right column of each form
item contains a set of icons that provide status information about the item and enable you to
display detailed item information. Information about detailed form item information appears
in the section that follows.
•
Command buttons—The Content-specific pane of a form contains command buttons that
enable you to perform activities that affect the form. Your responsibilities in the study and
the rights you have been assigned determine the buttons you can see and the actions you can
take. For example, if you have been assigned the right to print forms the Print Preview
button appears.
•
Select Action list—The Select Action list contains additional commands that you can
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Chapter 4 Taking a quick tour
perform by selecting a command in the list and clicking the Do command button.
Form views
Form views allow you to view form data in different ways.
Summary view
Summary view is available for repeating forms. In summary view, form data items appear in table
format with each form appearing in a row. Each row has an underlined number in the leftmost
column and a traffic light in the column next to it. When you click the number or the traffic
light, the detailed view of that row appears. You can sort these rows by clicking the column
headings. If applicable, a frozen or locked icon also appears in this column.
The far right column displays a comment and audit trail icon that provide access to comments
and audit trail activity that apply to a particular instance of the form. For example, to view the
audit trail of a deleted instance (indicated with each data item crossed out), click the audit trail
icon for that instance.
Using summary view to initiate commands on multiple instances
The summary view is useful for performing the same action, such as locking, freezing, source
verifying, or deleting, on several different form instances at the same time.
To perform one action on several forms:
1
50
In the summary view, click the action button you want to perform. (If the action does not
appear in the row of command buttons, find it in the Select Action list and click Apply.) The
summary view reappears with a column of check boxes along the left side.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
InForm 4.6 SP3
2
Select the checkbox next to the form instance or instances on which you want to perform
the action you selected in step 1.
3
Click the button for the action you want to perform (for example, Mark SV Ready).
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Chapter 4 Taking a quick tour
Detailed view
Detailed view is available for instances of a repeating form. In the detailed view, form data items
appear in a table format with a question on the left and the data entry controls for answering the
question on the right.
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InForm 4.6 SP3
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Cross reference view
The cross reference view is for forms that are defined as associated forms during trial design. The
page is divided in half horizontally, so that it displays two associated forms at the same time. The
forms behave the same way whether you are in cross reference view, summary or detailed view.
Navigating between the form views
You can move between the three different views to see a list of all visits as well as detailed
information for a single visit. Use this table to navigate between the different form views.
To move from
To
Select
Summary view
Standard view
The number in the far-left column of the
instance you want to see.
Standard view
Summary view
[Summary] in the drop-down list.
Standard view
Cross reference view
There is no standard view if the form can be
associated with another form. The two forms
always appear in cross reference view.
Summary view
Cross reference view
The number in the far-left column of the
instance you want to see.
Cross reference view
Summary view
[Summary] in the drop-down list.
InForm 4.6 SP3
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Chapter 4 Taking a quick tour
Patient visit information
When you display the forms for a patient visit, the time line and tabs at the top of each form
summarize the visits in the study. You can navigate to forms within the current visit and
throughout the trial.
To view visit information:
1
In the Navigation pane, click Patients.
2
Click the traffic light icon for the patient and visit.
Things to note
•
Visit navigation timeline—Use the timeline at the top of the page to navigate to other
visits within the trial. The name of the current visit is highlighted in yellow. To go to a
different visit, click the visit name.
•
Form navigation tabs—Use the tabs under the timeline to display each form in the current
visit. To go to a different form, click corresponding tab. The tab of the current form is
highlighted in yellow.
•
Time and Events Schedule navigation arrow—This yellow, upward-pointing arrow is
located next to the timeline. Click the arrow to go to the Time and Events Schedule.
Form item details
Comments
Comments are blocks of text in which you can enter any pertinent additional details about a
form item. On the Comment page you can create, update, or view a comment on an individual
form data item or on the entire form. You can use the Comment page to:
•
Add a new comment, if none currently exists.
•
Edit the text of an existing comment.
•
Add information to the text of an existing comment.
•
Replace an existing comment.
Note: To enter comments, you must have the appropriate rights in the study.
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The Comment page for a form or data item contains the current version of the comment text.
The changes made to the comment text are tracked in the history of the comment.
To view the page:
•
From the detailed view of a CRF, click the comment icon in the farthest right column of a
form item.
To display a form comment:
•
In the upper-right corner of the form, click the comment icon.
The table describes comment icons.
Icon
Description
Gray icon:
•
In the upper-right corner of a form, indicates that there is no comment on the
form as a whole.
•
In the farthest right column of a form item, indicates that there is no comment
on the item.
To type a comment, click the icon.
Yellow icon:
•
In the upper-right corner of a form, indicates that a comment exists on the
form as a whole.
•
In the farthest right column of a form item, indicates that a comment exists on
the item.
To view or update the comment, click the icon.
InForm 4.6 SP3
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Chapter 4 Taking a quick tour
Things to note
•
Current data value—The current value of the data item appears at the top of the page.
•
History—If more than one addition or update has been made to a comment, the history list
enables you to view details about each addition or update.
•
Comment details—The Selected Comment section provides details about the comment
version selected in the History list.
•
Command buttons—The command buttons in the Content-specific pane enable you to
submit a comment addition or update or to return to the form without saving changes.
Queries
The Queries page enables you to create, respond to, change the status, or review the details of
queries on a specific form data item, in accordance with your responsibilities and rights in a trial.
The detail page provides information about the current status and the history of queries on the
item. In this tour, the CRC user can answer queries, and the examples reflect the version of the
Queries page that supports this activity.
To view the page:
•
Icon
Click the query icon in the far-right column of a form item that has a query. The following
table describes the different query icons.
Description
Gray icon—Appears in the far-right column of a form item without any queries
against the item. Click the icon to enter a query.
This icon appears only if you have the right to issue queries.
Yellow icon—Appears in the far-right column of a form item if a query has been
entered against the item and the query is not closed. Click the icon to view or
update the query.
Green icon—Appears in the far-right column of a form item if the item has a
history of queries.
•
For site users, indicates that there are no open queries.
•
For sponsor users, indicates that all queries have been resolved.
Click the icon to view the query history.
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Things to note
•
Current data value—The current value of the data item appears at the top of the page.
•
Query History—If more than one query has been issued on an item, the history list enables
you to view details about each query.
•
Query details—The Query section provides details about the query selected in the History
List. The appearance of this section varies with the type of query activity for which you are
responsible, and with the state of the query.
For example, if you have been assigned the right to answer a query, as in this example, a row
called Answer Text includes the controls for selecting or entering an answer. After you have
submitted an answer, the Answer Text row becomes a read-only section in which your
answer is visible, and the Query State changes to Answered. If you have been assigned the
right to issue a query, the Query section includes data entry controls in the Query Text row.
•
Command buttons—The command buttons in the Content-specific pane enable you to
submit a query response or to return to the form.
Audit Trail
The Audit Trail page enables you to review the history of changes made to a specific form data
item, along with a history of query activity on the item.
To view the page:
•
InForm 4.6 SP3
Click the audit trail icon in the rightmost column of a form item. The following table
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Chapter 4 Taking a quick tour
describes the different types of audit trail icons.
Icon
Description
Gray icon—Appears in the far-right column of a form item.
Indicates that no subsequent changes have been made to the initial data value of
the item. Click the icon to view the audit trail for the initial entry.
In the summary view of a repeating form, an audit trail icon appears in the
far-right column of each instance of the form.
Yellow icon—Appears in the far-right column of a form item.
Indicates that changes have been made to the initial data value of the item. Click
the icon to view the audit trail for the item.
In the summary view of a repeating form, an audit trail icon appears in the
far-right column of each instance of the form.
Things to note
58
•
Current data value—The current value of the data item appears at the top of the page.
•
Audit trail—The history of data value changes and query activity appears in a table that
indicates the date and time of activity and the responsible user.
•
Links to details—Each item in the audit trail is underlined, indicating a link to more
detailed information. To view details, click the underlined text.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Data Value(s)
The Data Value(s) page enables you to change the value of a specific form data item and provide
a required reason for the data value change. The actual title of the page is based on the form, on
which the data item appears.
To display the page:
•
Navigate to a form for a patient, and click the data value on the form.
Note: When you move the mouse over the item, the background color of the item darkens. To
select the item, click anywhere in the darkened area.
Things to note
InForm 4.6 SP3
•
Current data value—The current value of the data item appears at the top of the page.
•
Audit Trail selection— List of changes to the form item. Each entry consists of the date
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Chapter 4 Taking a quick tour
and time of the change and the logon name of the user who made the change. The list also
includes an item called Enter new value, which enables you to change the data item and enter a
reason for the change. To view the details of a change, select it from this list.
•
Change controls—The item and its controls appear in the Data Value(s) page just as they
are in the form. To change the value of a data item, enter the new value in these controls.
•
Clear icon—To clear the value of the data item, click the eraser-shaped icon to the right of
the item.
•
Reason for change—Each time you change or clear a data value, you must select or enter a
reason for change. This reason is recorded in the audit trail for the icon.
Form help
Form help is an optional feature that enables you to display the part of the documentation for
your study that describes a particular form item or page. If your study is set up with this feature,
you can navigate directly from the form item or page to the study documentation.
To display the page:
•
Click the underlined text of a form item or page.
The InForm application document window opens and displays the part of form help that
describes the item.
Things to note
•
60
Contents—Form help contents appear in the Table of Contents pane of the document
InForm 4.6 SP3
Step by Step for CRCs and CRAs
window. To display a specific help topic, click its link in the Table of Contents pane. In this
example, help is organized by form.
•
Page indexer—The page indexer is a multi-part control on the bottom left side of the
Content-specific pane. By clicking different parts of the control, you can move through the
pages of form help.
Navigating between detail pages and forms
When you display a detail page for a form item, you can move to other detail screens or you can
return to the form.
•
To move to other detail screens, click the tab for the page you want.
•
To go back to the form page, click Return in the Content-specific pane at the bottom of the
page.
Query Listing
The Query Listing page enables you to review a summary of all queries and to navigate to the
query view of a specific form with a query. Several filters of the list are available; by making
selections in the filters, you can specify the queries that you want to see in the list.
To display the page:
•
In the Navigation pane, click Queries.
Things to note
•
InForm 4.6 SP3
Filters—To make it easier to find specific queries, the Query Listing page includes a set of
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Chapter 4 Taking a quick tour
lists from which you can select queries for a specific patient, query status or the person who
issued the query.
•
Query summaries—The Query Listing consists of a table in which each row is a single
query, identified by site, patient, visit, CRF, item number, and issuer. When a query’s state
changes—for example, when an Opened query is answered—the query’s status is updated in
the table.
•
Links to query details—To display the detailed Query page for a specific query, click the
underlined text in the query row.
•
Page indexer—The page indexer is a multi-part control on the bottom left side of the
Content-specific pane. By clicking different parts of the control, you can move through the
pages of the Query Listing when the list of queries fills more than one page.
Study documentation
Overview: Study documentation
This section describes the types of study documentation that can be available if they are set up by
your trial administrators.
Protocol
The study protocol is the sponsor documentation that describes in detail how a study is to be
conducted.
To display the study protocol:
62
1
In the Navigation pane, click Documents.
2
Click the Protocol Guide tab, if it is not already selected.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Things to note
•
Contents—Protocol contents appear in the Table of Contents pane of the document
window. To display a specific protocol topic, click its link in the Table of Contents pane.
•
Page indexer—The page indexer is a multi-part control on the bottom left side of the
navigation pane. By clicking different parts of the control, you can move through the pages
of the protocol.
Form help
Form help provides information about how to obtain and fill in patient data in forms. If your
trial is set up to accommodate direct linking from a form item to help about the item, you can
display CRF help by using that method. You can also open form help from any location in the
InForm application by clicking Documents in the Navigation pane. This part of the tour describes
the second method of viewing form help.
To display Form help:
1
In the Navigation pane, click Documents.
2
Click the CRF Help tab, if it is not already selected.
Things to note
InForm 4.6 SP3
•
Contents—Form help contents appear in the Table of Contents pane of the document
window. To display a specific help topic, click its link in the Table of Contents pane. In this
example, help is organized by form.
•
Page indexer—The page indexer is a multi-part control on the bottom left side of the
Content-specific pane. By clicking different parts of the control, you can move through the
pages of form help.
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Chapter 4 Taking a quick tour
Visit Calculator
The Visit Calculator provides a quick way to estimate visit dates based on a selected start date.
After you enroll a patient, the Visit Calculator page appears and computes suggested visit dates
based on the date of the enrollment visit. Afterwards, to display the Visit Calculator, use the
Documents window, as described in this section.
To display the Visit Calculator:
1
In the Navigation pane, click Documents.
2
Click the Visit Calculator tab, if it is not already selected.
Things to note
•
Start date—This control enables you to enter any date as the first visit date. Subsequent
visit dates are recalculated from the date that you specify.
•
Patient schedule—This section displays suggested visit dates based on the start date. After
calculating visit dates, you can print the Visit Calculator page by using the browser’s print
facility and fill in the Scheduled Date and Time column on paper.
Sample Case Book
The sample Case Book includes a copy of each form in the trial, organized by visit. This sample
set of forms is for display only; you can use it to familiarize yourself with the forms in your trial.
To display the sample Case Book:
64
1
In the Navigation pane, click Documents.
2
Click the Sample Book tab, if it is not already selected.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Things to note
InForm 4.6 SP3
•
Visit navigation controls—The controls at the top of the sample Case Book enable you to
move between visits.
•
Form tabs—Each tab displays the corresponding sample form when you click the tab.
•
Return button—Returns you to the protocol view of the document window.
•
Close button— Closes the document window.
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Chapter 4 Taking a quick tour
Online help
The InForm application online help describes the features of the product and explains how to
use them. You can display online help at any time while the InForm application is running.
To display the InForm application online help:
•
In the Navigation pane, click Help.
Things to note
•
Contents tab—Displays the contents of the guide in an expandable and collapsible
hierarchy. You can click on book and page icons to navigate through the guide.
•
Index tab—Displays a multi-level list of keywords that help you find information in the
guide.
•
Search tab—Opens a search page on which you can search for specific words and phrases
in the guide.
Logging off
This concludes the part of the tour visited as the user mmeyer.
To log off, the mmeyer user clicks Logout in the Navigation pane, then clicks Yes in the
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Step by Step for CRCs and CRAs
confirmation dialog box.
In the next part of the tour, you will visit some additional screens to which the sample user
named mlynch has access.
InForm 4.6 SP3
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Chapter 4 Taking a quick tour
Visiting CRA pages
Starting the tour: User mlynch
In this part of the tour, a user who has the user name mlynch does the following:
1
Opens an Internet browser
2
Types the URL for the assigned study site, and presses Enter.
3
On the logon page, types mlynch and the password.
4
Clicks Log In.
The InForm application home page for the trial appears. This page is customized for each
study and can include many types of information.
The Navigation pane, on the left side of the screen, contains buttons that provide access to
the pages you will visit.
Note: When you are working with the InForm application, do not use the web browser refresh
button. This action can cause problems for the trial.
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Case Books List
The Case Books List summarizes the status of forms and visits for each patient and lets you
navigate to specific patients and visits. The Case Books List is a convenient place to view the log
of enrolled patients.
To display the Case Books List:
•
In the Navigation pane, click Patients.
Things to note
InForm 4.6 SP3
•
Highlight—A series of checkboxes let you filter the display of traffic light icons for visits
that contain forms that are started, incomplete, frozen, locked, or contain queries. Traffic
lights for visits that contain forms that match all of your selections are highlighted
•
Patient status—The Status column indicates the stage at which the patient is in the study.
•
Visit status—Each patient has one traffic light icon for each visit. The colors of the traffic
light show whether the forms for each visit are complete.
•
Links to patient visit—Each traffic light icon is a link to the patient forms for a visit.
•
Page indexer—The page indexer is a multi-part control on the bottom-left side of the
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Chapter 4 Taking a quick tour
content-specific pane. By clicking different parts of the control, you can move through the
pages of the Case Books List when the list of study subjects fills more than one page.
•
Show Transferred button—This button displays a list of patients who have been
transferred into or out of the sites to which you have access.
•
Links to Time and Events Schedule—The underlined patient number and initials and the
underlined patient status indicate links to the patient’s Time and Events Schedule. To display
the schedule, click the underlined text.
•
Flags—A yellow flag on a traffic light indicates the presence of one or more answered
queries.
Time and Events schedule
The Time and Events Schedule is a list of forms and visits for a specific patient. This page lets
you review the status of forms and visits, and navigate to a specific form.
To display the Time and Events schedule:
1
In the Navigation pane, click Patients.
2
Click the patient number or status of the patient.
Things to note
•
70
Highlight—A series of checkboxes let you filter the display of traffic light icons for forms
InForm 4.6 SP3
Step by Step for CRCs and CRAs
that are started, incomplete, frozen, locked, or contain queries. Traffic lights for forms that
match all of your selections are highlighted. You can also filter for Source Verification status.
•
Visits and CRFs—The Time and Events Schedule consists of a list of visits and forms. A
traffic light icon indicates which forms must be completed at each visit.
•
Form status—Each traffic light icon indicates the state of completion of a form at a
specific visit.
•
Links to CRFs—Each traffic light also provides a link to a form; to display the form, click
the traffic light icon.
•
Command buttons—The command buttons in the content-specific pane let you perform
activities that affect the patient’s entire Case Book. For example, as a CRC you might be
assigned the right to mark a Case Book ready for source verification by clicking the
appropriate command button in the Time and Events Schedule.
•
Flags—A yellow flag on a traffic light indicates the presence of one or more answered
queries.
Source verification and monitoring screens
A user with rights to perform monitoring activities has access to screens that support source
verification and site monitoring.
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Chapter 4 Taking a quick tour
Source Verification Listing
The Source Verification Listing enables you to review the source documentation status of CRFs
and to navigate to the Source Verification view of a specific CRF so that you can perform source
verification. Several filters of the list are available; by making selections in the filters, you can
specify which CRFs you want to see in the list.
To display the page:
•
In the Navigation pane, click Monitor.
Things to note
72
•
Filters—To make it easier to find specific forms, the Source Verification Listing includes
drop-down lists from which you can choose to display a list of forms for a specific site and
patient. You can also filter the list by source verification state, by CRF completion state, and
by numerous content and status criteria. You can create and save custom filters. For more
information, see Filtering the source verification listing (on page 158).
•
Check boxes—A column of check boxes allows you to select one or more forms and
perform a group freeze, unfreeze, lock, or unlock on them by clicking the appropriate button
in the lower right corner of the page.
•
Source verification summary—For each form, the Source Verification Listing displays the
site, patient number and initials, visit, form abbreviation, source verification status, and CRF
completion status.
•
Page indexer—The page indexer is a multi-part control on the bottom left side of the
Content-specific pane. By clicking different parts of the control, you can move through the
InForm 4.6 SP3
Step by Step for CRCs and CRAs
pages of forms in the Source Verification Listing.
•
Link to source verification view of form—Form names are underlined, indicating the
presence of links from this page to each listed form. To display a source verification view of
a form, click the underlined form name.
•
Freeze/Lock buttons—The buttons in the lower right corner of the page enable you to
freeze, lock, unfreeze, or unlock the forms for which you have selected the check boxes.
Note: The Source Verification Listing page displays each instance of a repeating form as a
separate row. The number of the instance is added to the name of the form: for example,
AE[1], AE[2].
SV Report
The SV Report (Source Verification Report) is a formatted listing of one or all forms that exist
for a patient. When you print the SV Report, you can obtain a complete printed copy of the
forms so that you can perform source verification offline. The SV Report consists of two
screens: a list of patients for whom you can generate reports, and a page on which you can select
the form or forms you want to print. After generating a view of the form or forms online, you
can print it by clicking the Print button.
To display the page:
InForm 4.6 SP3
1
On the Navigation pane, click Monitor.
2
Click the SV Report tab.
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Chapter 4 Taking a quick tour
Things to note
•
Sortable columns—You can sort the report by using the data in the Site, Patient Number,
or Patient Initials columns. To change the sort order of one of those columns, click the
column heading. In the column used for the primary sort, the heading includes an arrow that
indicates the sorting direction.
•
Page indexer control—This control enables you to move to a different page of the SV
Report list when the information fills more than one page. To use the page indexer control,
click the appropriate arrow, or select a page number from the drop-down list.
•
Print Preview link—Each Case Book in the SV Printout list has a Print Preview button that
enables you to display a page on which you can select the form you want to print or specify
that you want to print all forms.
SV Report print preview
The print preview page displays a view of a form in a format suitable for printing. From this
page, you can print the form, or you can print all forms in the Case Book.
To display the page:
74
1
In the Navigation pane, click Monitor.
2
Click the SV Report tab.
3
Click the Print Preview link for the form you want to print.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Note: To generate a print preview of the entire Case Book, click any Print Preview link.
Things to note
•
Navigation arrows—Use these arrows to select a different page to print. Forms are in the
same order in which they occur in the study.
•
All button—This button displays a version of the SV report that includes the entire Case
Book.
•
Print button—This button prints the SV Report.
Visit Report
The Site Visit Report is a form that enables you to prepare a site visit report. The format of this
page, which is an optional feature of the InForm application, is completely customizable for each
trial and is created when your trial is set up.
To display the page:
InForm 4.6 SP3
1
In the Navigation pane, click Monitor.
2
Click the Visit Reports tab.
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Chapter 4 Taking a quick tour
The page lists any existing reports. To display a report, click the site name or date of the
report.
3
To create a new visit report:
a
In the Content-specific pane, select the site for which you want to create the report.
b
Click New.
A visit report form appears.
c
Fill in the form and click Submit.
Required Signatures list
The Required Signatures page enables you to review the status of forms and case books that
require signature and to navigate to the electronic signature form for a specific form or case
book. Several filters of the list are available; by making selections in the filters, you can specify
which forms or case books you want to see in the list.
Note: The information presented in the Required Signatures page varies according to whether
you have rights to sign forms or case books or to view signature information about forms or
case books. In this example, the CRC user can view signature information about forms and
case books but cannot sign. Therefore, the Required Signatures page includes the words
(Read-Only) in the title.
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Step by Step for CRCs and CRAs
To display the Required Signatures page:
•
In the Navigation pane, click Signatures.
Things to note
•
Filters—To make it easier to find information about a specific form or case book, the
Required Signatures page includes a set of lists from which you can select forms or case
books for a specific site, patient, signature state (signed or unsigned), or form or case book
state.
•
Signature summary—For each form or case book in the list, the Required Signatures page
includes the site, patient number and initials, signature date (if signed), signature status, and a
traffic light icon indicating form or case book completion status. Form rows also include the
visit name and form abbreviation.
•
Page indexer—The page indexer is a multi-part control on the bottom left side of the
Content-specific pane. By clicking different parts of the control, you can move through the
pages of CRFs or case books in the Required Signatures list.
•
Form status—The Status column displays a traffic light status icon indicating the status of
the form.
•
Signature status—The Signatures column indicates signature status. If a form or case book
requires signature and a user has rights to sign forms or case books, this column contains a
Sign link that displays the appropriate signature affidavits and enables the user to sign them.
Icon
InForm 4.6 SP3
Description
77
Chapter 4 Taking a quick tour
Icon
Description
CRF has been signed by all required signatories. This symbol is visible only if
you have been assigned the right to view CRF signing information.
Case book has been signed by all required signatories. This symbol is visible
only if you have been assigned the right to view case book signing
information.
CRF has not been signed by all required signatories. This can mean that the
CRF or Case book has never been signed or that signatures have been
invalidated by data updates. This symbol is visible only if you have been
assigned the right to view CRF signing information.
Case book has not been signed by all required signatories. This symbol is
visible only if you have been assigned the right to view case book signing
information. This can mean that the CRF or Case book has never been signed
or that signatures have been invalidated by data updates.
•
Details link—To display the signing history of a form or case book, click the View link in
the Details column.
Reg Docs
The Regulatory Documentation Checklist is a form that enables you to fill in a checklist
describing a site’s regulatory documentation. The format of this page, which is an optional
feature of the InForm application, is completely customizable for each trial and is created when
your trial is set up.
To display the page:
78
1
In the Navigation pane, click Monitor.
2
Click the Reg Docs tab.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Things to note
Site links—To display the Regulatory Documentation Checklist for a specific site, click the
underlined site name.
Logging off
This concludes the part of the tour visited as the user mlynch.
To log off, the tallen user clicks Logout in the Navigation pane, then clicks Yes in the
confirmation dialog box.
InForm 4.6 SP3
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Chapter 4 Taking a quick tour
80
InForm 4.6 SP3
CHAPTER 5
Screening
In this chapter
Overview: Screening ............................................................................................................................ 82
Accessing candidate information ....................................................................................................... 83
Screening a study candidate ................................................................................................................ 84
What to do if... ...................................................................................................................................... 86
InForm 4.6 SP3
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Chapter 5 Screening
Overview: Screening
Enrolling a patient in a trial involves the following processes:
1
Screening a candidate. Complete a screening form that records some basic candidate
information and indicates whether the candidate is eligible for the trial. When you submit the
screening form, the candidate is added to the Screening Log.
2
Enrolling the candidate. Enrolling is a two-step process in which you:
a
Enter data on the Enrollment form. This data records whether a screened candidate
meets the enrollment criteria of the study.
Note: If some information is not available when you begin the Enrollment form,
you can enter partial enrollment data and submit the incomplete form. Then, at a
later time, you can return to the form, complete the data, and submit the form
again.
b
82
Complete the enrollment of the candidate.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Accessing candidate information
The InForm application does not set up a case book for the patient until the final phase of
enrollment is complete. Until the case book is created, the only way you can access information
about a candidate is through the Screening Log. Both screening and enrollment information is
available through links from the Screening Log.
To display the Screening form of a candidate:
•
Click the candidate’s underlined screening number.
To display the Enrollment form of the candidate:
•
InForm 4.6 SP3
In the Enrolled column, click the symbol or button that corresponds to the candidate.
83
Chapter 5 Screening
Screening a study candidate
To screen a study candidate:
1
In the Navigation pane, click Enroll.
The Screening Log appears.
2
84
Click Add Candidate.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The Screening form appears.
3
On the Screening form, enter screening data, and click Submit.
The Screening Log reappears. The study candidate is added to the end of the list.
InForm 4.6 SP3
•
If screening was successful, the Enrolled column for the candidate contains an Enroll
button.
•
If screening failed, the Enrolled column contains X, and the Screening Failure column
contains information about why the screening was unsuccessful.
•
A checkmark indicates that the candidate has been successfully enrolled.
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Chapter 5 Screening
What to do if...
Submitting results in a screening failure
The Screening Log lists the names of all candidates who have been screened. The Enroll column
indicates the following:
Enroll column contains
Meaning
Enroll button
Candidate has been successfully screened
X
Screening failed. Candidate is not eligible for the trial.
If you believe that the candidate should be eligible for the trial, do the following:
1
In the Screening Log, look in the Screening Failure column to determine why the screening
failed.
2
Click the underlined screening number for the candidate to display the screening form. Make
necessary changes according to the table:
If screening failed because
Do this
Some screening data is missing.
Complete the Screening form, then click Submit.
The patient is ineligible for the trial.
Check the data and make corrections if necessary.
To correct a data value:
1
Click the entered value.
2
On the Data Value(s) page, type the correct
value and select or type a reason for change.
3
Click Submit.
4
5
3
86
A confirmation dialog box appears. Click
OK.
Click Return to go back to the Screening
form.
Click Submit.
InForm 4.6 SP3
CHAPTER 6
Enrolling
In this chapter
Overview: Enrolling ............................................................................................................................. 88
Enrolling a study candidate................................................................................................................. 89
What to do if... ...................................................................................................................................... 92
InForm 4.6 SP3
87
Chapter 6 Enrolling
Overview: Enrolling
Enrolling is a two-step process in which you:
88
•
Enter data on the Enrollment form. The information is used to determine whether the
patient meets the enrollment criteria of the study.
•
Complete the enrollment of the candidate.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Enrolling a study candidate
To enroll a study candidate:
1
In the Navigation pane, click Enroll.
The Screening Log appears.
2
Locate the candidate you want to enroll.
Note: New candidates are always added to the end of the Screening Log. To advance
quickly to the end of the Screening Log, use the page indexer control (on page 27).
3
InForm 4.6 SP3
In the Enrolled column, click Enroll for the selected patient.
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Chapter 6 Enrolling
The Enrollment form appears.
4
Complete the Enrollment form to record whether the candidate conforms to the inclusion
and exclusion criteria for the trial.
5
Click Submit.
6
If all data is present on the Enrollment form and the candidate meets all inclusion and
exclusion criteria, a message page appears, indicating that the patient meets all study criteria
and can be enrolled.
For information about what to do if the patient cannot be enrolled because of missing data
or nonconformance with inclusion and exclusion criteria, see What to do if... (on page 86)..
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7
To complete the enrollment, click Enroll.
The InForm application processes the enrollment by:
8
•
Updating the Screening Log—The InForm application adds the patient number to
the Patient Number column and changes the entry in the Enrolled column to a check
mark.
•
Changing the Enrollment form to a read-only form—After enrollment is complete,
you can update enrollment data only if your trial is set up to include the enrollment data
on one or more enrollment forms in a regular patient visit.
•
Creating the case book for the patient—After enrollment is complete, you can access
patient visits and forms by clicking the Patients button in the Navigation pane.
•
Displaying the Visit Calculator page.
The initial display of the visit calculator uses the current date as the date of initial visit, and
computes the remaining visit dates based on that initial visit date.
•
•
9
InForm 4.6 SP3
To recalculate proposed visit dates, change the Start Date by selecting a new date in the
month, day, and year drop-down lists.
To print the visit calculator so that you can give it to the patient for reference, click the
of the browser.
Print button
Do one of the following:
•
To go directly to the first patient form, click Go to First Visit.
•
To return to the Screening Log, click Return.
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Chapter 6 Enrolling
What to do if...
Enrollment data is missing
If all enrollment data is not available when you fill out the Enrollment form, or if you missed any
required data items on the form, one of the following occurs:
•
If your protocol permits enrollment with incomplete enrollment data (on page 92), an
enrollment override page appears. After you obtain approval from an authorized Sponsor
representative, you can continue with enrollment.
•
If your protocol does not permit enrollment with incomplete enrollment data (on page
93), the InForm application returns you to the Screening Log after you submit the
Enrollment form. The Enrollment Failure column displays “Enrollment Form Incomplete”
as the reason for failure. The Enrolled column contains an X, which indicates that the
candidate has not been enrolled.
Enrollment is allowed with incomplete data
To override an enrollment failure and complete the enrollment:
1
Obtain approval from the appropriate Sponsor representative to override the enrollment
failure.
2
In the Navigation pane, click Enroll.
The Screening Log appears.
3
92
Locate the candidate you want to enroll.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
4
In the Enrolled column for the candidate, click X .
The Enrollment form appears.
5
Click Submit.
The enrollment override page appears.
6
Complete the Enrollment override page. You must provide information that documents your
discussion with the Sponsor representative and gives the reason for the override.
7
To complete the enrollment, click Enroll.
Enrollment is not allowed with incomplete data
To provide missing data and complete the enrollment:
1
InForm 4.6 SP3
In the Navigation pane, click Enroll.
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Chapter 6 Enrolling
The Screening Log appears, if it is not already visible.
2
Locate the candidate you want to enroll.
3
In the Enrolled column for the candidate, click the X.
The Enrollment form appears.
4
94
Enter data in the missing items. Items with missing data have a yellow background.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
5
Click Submit.
If all data is now present on the Enrollment form and the candidate meets all inclusion and
exclusion criteria, a message appears, indicating that the patient meets all study criteria and
can be enrolled.
6
InForm 4.6 SP3
To complete the enrollment, click Enroll.
95
Chapter 6 Enrolling
Candidate does not meet study criteria
If the patient does not meet all inclusion and exclusion criteria and the sponsor elects to use the
override feature, the Enrollment Override form appears.
On the Enrollment Override form, you have these options:
•
If the candidate is ineligible, you can complete the enrollment process by indicating that
enrollment is refused.
•
If the candidate is ineligible because of an error in data entry, you can correct the form and
attempt again to enroll the candidate.
•
If your trial protocol permits candidates who are appear to be ineligible to be accepted into
the study with approval from an appropriate Sponsor representative, you can override the
enrollment failure and complete the enrollment.
Candidate is ineligible
To refuse enrollment because the candidate does not meet eligibility criteria:
1
After you submit the Enrollment form, the enrollment override page appears. Click Do Not
Enroll.
A message appears, asking you to confirm that you are refusing enrollment.
2
Click OK.
The Screening Log appears. The Enrollment Failure column displays the reasons the
candidate is ineligible, and the Enrolled column contains an X, indicating that the candidate
has not been enrolled.
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Data entry error
The result of a data entry error can be that the patient fails to meet eligibility criteria.
To correct a data entry error:
1
After you submit the Enrollment form, the Enrollment override page appears. Click Return.
The Screening Log appears. The Enrollment Failure column displays the reasons the
candidate is ineligible, and the Enrolled column contains an X, indicating that the candidate
has not been enrolled.
2
In the Enrolled column, click X.
The Enrollment form appears.
3
Review the entries on the form, and correct any data entry errors as follows:
a
Click the entered value.
b
On the Data Value(s) page, type the correct value, and select or type a reason for
change.
c
Click Submit.
A confirmation message box appears.
4
d
Click OK.
e
To go back to the Enrollment form, click Return.
On the Enrollment form, click Submit .
If the candidate now meets all inclusion and exclusion criteria, a message appears, indicating
that the patient meets all study criteria and can be enrolled.
5
To complete the enrollment, click Enroll.
Enrollment failure override is permitted
An enrollment failure can be caused by either of the following reasons:
•
Patient did not meet eligibility criteria.
•
Patient data is incomplete.
To override the failure and complete the enrollment, use the procedure described in Enrollment
is allowed with incomplete data (on page 92).
You do not want to enroll an eligible patient
In some cases, even if a patient meets all eligibility criteria, the Principal Investigator for the site
can decide not to enroll the patient.
To refuse enrollment to an eligible patient:
1
InForm 4.6 SP3
After you submit the Enrollment form, the Patient Meets All Study Criteria message appears.
Click Do Not Enroll.
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Chapter 6 Enrolling
A message appears, asking you to confirm that you are refusing enrollment.
2
Click OK.
The Screening Log appears. The Enrolled column for the patient has an Enroll link,
indicating that the patient has not been enrolled.
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InForm 4.6 SP3
CHAPTER 7
Entering form data
In this chapter
Overview: Entering form data ......................................................................................................... 100
Entering form data ............................................................................................................................. 103
Form submitted successfully messages ........................................................................................... 104
Entering a form comment ................................................................................................................ 105
Associating forms ............................................................................................................................... 107
Adding an unscheduled visit ............................................................................................................. 109
What to do if... .................................................................................................................................... 110
InForm 4.6 SP3
99
Chapter 7 Entering form data
Overview: Entering form data
This section describes forms, items, and data-entry controls that are used to record different
types of patient data.
Form types
The InForm application supports the following types of Case Report Forms:
•
Regular form—contains data that is specific to the visit in which the form occurs.
•
Common form—contains data that is cumulative from visit to visit. Each time the form
occurs in a visit, it displays the data accumulated from all previous visits in which you
collected that data, and you can add to the data in the current visit. Examples of forms that
are often implemented as common forms are Concomitant Medication and Adverse
Experience forms.
Each of these forms can optionally be a repeating form, or a form that contains data that is
specific to two or more forms, or multiple times within the same form. If the design of your
study requires you to collect the same data for multiple forms, you can collect the data for each
specific form, and see all the data collected in other forms. Examples of forms that are often
implemented as repeating forms are Vital Signs and Physical Examination.
If you click on the tab of a repeating form, it first appears in summary view. To display the
detailed view of a form, click on the number or traffic icon to the left of the form row.
A repeating form can optionally be an associated form. Associated forms display two forms on a
split page. The two forms contain data that might or might not be related.
Item types
Forms can have the following types of items:
•
Items—Non-repeating data points on a form. Items can require you to enter or select a
single value or to specify multiple choices. The following figure shows examples of regular
data items.
•
Itemsets—Groups of items that repeat; for example, data for repeated labs. Each set of
items takes one row on the form.
To view each item in detailed view, click the underlined number at the beginning of the row.
In detailed view, you can enter comments, queries, and rules for individual items within an
itemset row and display audit trail information on an item-by-item basis.
To add a new row to an itemset, click Add Entry. You can sort the rows by clicking on the
underlined column headings. When you enter itemset data, you use a special screen that is
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InForm 4.6 SP3
Step by Step for CRCs and CRAs
separate from the main form.
Data-entry controls
The types of data-entry controls that appear on a form vary with the type of data that is
captured. The following table describes the types of data-entry controls and how to enter data in
each type.
Control type
Example
Mouse or keyboard action
Radio button
Select one.
Checkbox
Select one or more.
Drop-down list
Click the down arrow to display the list.
Then select the appropriate list item.
Tip: if you know the name of the list
item you want, click the mouse pointer
in the box and type the first letter of the
item. If more than one list item begins
with the letter, type the letter again until
the item you want appears.
Text box
InForm 4.6 SP3
Click the text box, then type the data.
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Chapter 7 Entering form data
Control type
Example
Date time control
Mouse or keyboard action
A date time control can include some or
all of the following parts: month, day,
year, hour, minute, and second.
or
Expanded calendar
Click the calendar icon to expand the
calendar. The date you select in the
expanded calendar appears in the
drop-down lists.
•
To insert the current date and time,
click Today.
•
To insert a different date, choose
the month and year by using the
drop-down lists. Then click the
date. The time field remains blank.
You can also use the drop-down lists to
select or change the month, day, year,
hour, minute, and second.
Your trial might be designed to show
time parts as text boxes. In this case,
enter the numerical values in each box.
Always enter time using a 24-hour
clock.
Note: Some data items require you to use more than one type of control to complete the
item. For example, if a checkbox is accompanied by a text box, select the checkbox, then
type text in the text box. The following figure illustrates this type of compound control.
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Entering form data
To enter data on a form:
1
In the Navigation pane, click Patients.
2
In the Case Books List, click the traffic light icon for the patient and visit you want to use.
3
Click the tab for the form.
An empty form appears.
4
5
Enter data as follows:
•
For regular items—Enter data from the source documents into the controls on the
form, using the methods described in Data-entry controls (on page 101).
•
For an itemset—Click Add Entry. Then, in the itemset Entry page that appears, enter
data from the source documents into the Data-entry controls (on page 101).
•
For a repeating form—Click New. Then, on the Entry page, enter data from the source
documents into the Data-entry controls (on page 101).
Click Submit.
You receive a confirmation message if the data is submitted successfully. Depending on the
design of your study, the message appears either in the title bar of the form, or in a separate
dialog box in which you click OK. For more information, see Form submitted
successfully messages (on page 104).
6
Click Return.
You return to the main form from an itemset or repeating form entry page.
InForm 4.6 SP3
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Chapter 7 Entering form data
Form submitted successfully messages
After you provide data on a form, you click the Submit button. If submission is successful, the
"Form Submitted Successfully" message appears.
Depending on how your trial is designed, the message could appear in either of the following
ways:
•
As a pop-up message box
If the message "Form Submitted Successfully" appears in a pop-up box, click OK to
acknowledge the message and continue using the InForm application.
•
As a message in the title bar of the form
The message "Form Submitted Successfully" appears in yellow, to the right of the title of the
form. You do not have to respond to the message in any way. You can continue using the
InForm application.
Depending on how your trial is designed, the message either remains for several seconds and
then fades from view, or it remains visible until you perform another action on the form.
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Entering a form comment
You can enter a comment on a form item or on an entire form.
Entering a comment on a form item
To enter a comment on a form item:
1
In the Navigation pane, click Patients.
2
In the Case Books List, click the traffic light icon for the patient and visit you want to use.
3
Click the tab for the form.
4
Do one of the following:
5
•
For an item in an itemset or repeating form—Click the row number of the itemset
or repeating form instance for which you want to add a comment.
•
For a regular item—Skip this step.
Click the comment icon (
) in the far-right column of the item.
The Comment page appears.
InForm 4.6 SP3
6
In the Comment box, enter the text of the comment.
7
Click Submit.
8
In the confirmation box, click OK.
9
Click Return..
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Chapter 7 Entering form data
Note: The comment icon for the form item is yellow and contains an exclamation point
(!), indicating that a comment exists.
Entering a comment on a form
To enter a comment on a whole form:
1
In the Navigation pane, click Patients.
2
In the Case Books List, click the traffic light icon for the patient and visit you want to use.
3
Click the tab for the form.
4
Click the comment icon in the upper-right corner of the form.
The Comment page appears.
5
In the Create/Edit Current Comment box, enter the text of the comment.
6
Click Submit.
7
In the update confirmation box, click OK.
8
Click Return to return to the form.
The comment icon for the form is now yellow and contains an exclamation point (!),
indicating that a comment exists.
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Associating forms
Form association is the ability to establish a relationship between two repeating forms.
Associating the information on forms can make it easier to recognize possible relationships
between collected data, study drugs, adverse reactions and concomitant medication.
A form can have zero-to-many associations. Study designers define the ability to link two forms.
If your study is set up with this feature the lower half of the page lists the possible instances of
forms that can be associated when you create a new instance of a form.
For example, an instance of an adverse event can be linked to a concomitant medication, and
that particular concomitant medication can be linked to one or more adverse events.
Creating an association
To create an association:
InForm 4.6 SP3
1
Be sure that data exists on the two forms that you want to link.
2
Display the summary view of one of the forms.
3
From the summary view, select the number in the far-left column for the form you want.
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Chapter 7 Entering form data
The bottom half of the page displays the forms that can be linked with the form you
selected.
4
Select the checkbox for the form instances that you want to link.
5
To save the association, click Submit.
After you have created an association between instances of two repeating forms, the summary
view of each form includes the associated instance of the other form, and you can navigate from
one instance to the other.
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Adding an unscheduled visit
If your trial has unscheduled visits, the Case Books List and Time and Events schedule include
an Unscheduled column. To add an unscheduled visit for a patient:
1
Go to an Unscheduled visit for the patient. (If the patient has previous unscheduled visits,
click New in the Content-specific pane of the InForm application window to display a blank
visit.)
2
Type the visit date and time in the date and time item on the first CRF of the visit.
3
Click Submit.
If the visit contains more than one form, the additional forms become visible after you
submit the date and time. The Time and Events Schedule is updated to show the name of
the unscheduled visit.
4
InForm 4.6 SP3
Complete the rest of the visit CRFs.
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Chapter 7 Entering form data
What to do if...
You find a data-entry error after submitting
A data-entry error might automatically generate a query, if it is caught by the built-in edit checks
on a data-entry item. For information about how to correct a data-entry error and answer a query
simultaneously, see Answering queries (on page 133).
To correct an error that does not automatically generate a query:
1
Click the entered value.
The Data Value(s) page appears.
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2
Enter the correct value and select or enter a reason for change.
3
Click Submit.
You receive a Form Submitted Successfully message, either in the heading or as a message
box. If a message box appears, click OK.
4
Click Return.
You return to the form.
Complete data is unavailable
If you cannot complete an entire form in one data-entry session, submit the form with data
partially entered. The background color of incomplete items changes to yellow, so you can find
them easily when you return to the form later and enter the missing data.
A query is generated
A data entry might automatically generate an open query when you submit the CRF, if the entry
is caught by the built-in edit checks on a data entry item. When an automated query is generated
in the Opened state:
InForm 4.6 SP3
•
The background color of the form item changes to pink.
•
The text of the query appears underneath the form item.
•
The yellow query flag appears in the far right column of the item.
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An item is inapplicable, unknown, or not done
If your study protocol permits, you can skip form items if they meet any of the following criteria:
•
The item on the form does not apply to the subject.
•
The data is not available.
•
The procedure collecting the data for an item was not done.
To mark an item as skipped:
1
Instead of entering data in the item, click the Comment icon for the item to display the
comment page. In the Reason incomplete section of the Comment page, select the reason that
best describes why you are leaving the item blank.
2
Click Submit.
3
In the confirmation message box, click OK.
4
To return to the form, click Return..
The item reflects the Reason selection you made, and the background color of the item is
gray, indicating that it is considered complete.
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A form is not applicable, unknown, or not done
In some cases it might be appropriate to skip an entire form. If your study protocol permits, you
can skip form for any of these reasons:
•
The form is not applicable.
•
The data is not available.
•
The procedures the form documents were not done and the data were not collected.
To mark a form as skipped:
1
Instead of entering data in the form, enter a comment that describes the reason the form is
skipped. In the If Incomplete, Reason section of the Comment page, select the reason that best
describes why you are leaving the item blank.
2
Click Submit.
3
In the confirmation message box, click OK.
4
Click Return to return to the form.
The items on the form reflect the Reason selection you made, and the background color of
the items is gray, indicating that they are considered complete.
An item is not editable or visible
During study design, items can be marked as editable, read-only or hidden. Whether you can
mark an item depends on the rights groups to which you belong. For example:
InForm 4.6 SP3
•
If you can not see an item on a form, you might not have rights to view that item.
•
If you can see an item, but are not allowed to edit, or enter data for it, you might not have
rights to edit that item.
•
If the form is blank or empty, the items and itemsets on the form might all be designated as
hidden display override.
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114
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CHAPTER 8
Updating form data
In this chapter
Overview: Updating form data......................................................................................................... 116
Updating form data ............................................................................................................................ 120
Clearing data ........................................................................................................................................ 124
Deleting or undeleting an itemset .................................................................................................... 126
What to do if... .................................................................................................................................... 131
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Chapter 8 Updating form data
Overview: Updating form data
This section describes the following:
116
•
The Data Value(s) page, which you use to update data on a form.
•
The audit trail, which keeps a record of all changes to data items.
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Data Value(s) page
The Data Value(s) page is used to update a form item. This page is linked to each data item.
When you click the value that is entered in the form, the Data Value(s) page appears and displays
the current value of the item. The page also includes a way to access previous values the item has
held, a set of data-entry controls for changing the value of the item, and a section where you
provide the reason the item is being changed.
Audit trail
Each time you change the value of a data item, an audit trail records the date and time of the
change, the user name of the person making the change, and the reason for the change. You can
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Chapter 8 Updating form data
review the audit trail of an item in several ways:
•
On the Data Value(s) page—Select a change date and time from the Audit Trail list.
The details of the change appear in the Reason for Change section.
•
On the Data Value(s) page—Click the Audit Trail tab.
•
On the form—Click the audit trail icon for the item whose audit trail you want to view.
Audit trail date/time conversion
The time (Date hour:min:sec) at which you enter data into the InForm application is stored in
the InForm database in GMT (Greenwich Mean Time). However, the time that displays in the
InForm audit trail depends on the time zone you specify for a site. You specify the time zone for
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a site through processing of the Site MedML, or by selecting a Time Zone on the Site's detail
page when creating a site through the InForm Admin interface.
Valid time zone values must match those provided by Microsoft in the registry for your
operating system. In addition to the list of time zone names, Microsoft stores each time zone's
offset from GMT and details on the start and end date/time of daylight saving time where
applicable. The InForm application uses this information to convert the data entry date/time
stamp to the time zone for the site.
The InForm application:
InForm 4.6 SP3
1
Reads the audit date/time stamp from the database.
2
Retrieves the site's time zone setting specified in the InForm metadata.
3
Looks up the site time zone in the operating system registry, returns the necessary offset
information, and determines whether the date/time in question in within or outside the
daylight saving time adjustment.
4
Converts the date/time stamp from the database according to the offset information and
displays the converted information in the audit trail in the user interface.
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Chapter 8 Updating form data
Updating form data
To update data on a form:
1
In the Navigation pane, click Patients.
2
In the Case Books List, click the traffic light icon for the patient and visit you want to use.
3
Click the tab for the form.
Note: A yellow exclamation point on a tab indicates that there is work to be done on the
form.
4
120
Do one of the following:
•
To update a regular item—Click the cell with the control that you want to change.
•
To update a value in an itemset—Click the itemset row number.
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The Data Value(s) page appears. For a regular item, only the selected item is visible.
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Chapter 8 Updating form data
For an itemset, all items in the itemset are visible.
5
In the Enter New Value section of the page, select or type the new value of the item.
6
In the Reason for Change section of the page, select or type the reason you are changing the
data.
7
Click Submit.
8
In the confirmation message box, click OK.
9
Click Return.
You return to the form. Note the changes of appearance in the item:
122
•
If the data change answers a query, the background color changes from pink to gray.
•
If the data change clears the value from the item, the item is incomplete. The
background color changes from gray to yellow.
•
If this was the first time the data value was changed since initial data entry, the audit trail
icon changes from gray to yellow to indicate the existence of additional events in the
audit trial.
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Step by Step for CRCs and CRAs
If you deleted an itemset:
InForm 4.6 SP3
•
The original itemset values are visible but crossed out.
•
If the itemset or item had a query, the query is cleared.
•
If the itemset row was part of a rule, the rule is not refreshed.
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Chapter 8 Updating form data
Clearing data
Implications of clearing data
The following table describes what happens when you clear data from a form.
Affected area
What happens when you clear an item
Queries on a cleared item.
In a regular CRF with no itemsets, the following status changes
occur:
•
An Automatic query is changed to Closed.
•
For manual queries:

An Opened query is changed to Answered.

A Candidate query is purged.

Other queries are unchanged.
In a CRF with itemsets, queries on an itemset are treated as if
the itemset were one item, and the same status changes occur
as for an item.
Itemsets.
If an itemset has been deleted, the deleted data is cleared. The
audit trail records two entries indicating that the data was
deleted and then cleared.
Calculated control.
The value of the calculated control is cleared if the calculated
control depends on the cleared item.
CDD mapping for a cleared item.
The value mapped to the CDD is cleared along with the value
of the cleared item.
Patient number.
After a Patient Number is entered, it cannot be cleared.
Randomization number.
After a Randomization Number is calculated, it cannot be
cleared.
Clearing data from an item
To clear data from an item, use the reset value icon
in the far right column of the form:
To clear data before submitting it:
•
Click the reset value icon in the same row as the item.
To clear data that has already been submitted:
124
1
Click the entered value.
2
On the Data Value(s) page, click the reset value icon and select or enter a reason for the
change.
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Step by Step for CRCs and CRAs
3
On the Data Value(s) page, click Submit.
The confirmation dialog box appears.
4
Click OK.
The color of the item row background changes from gray to yellow, to indicate that the item
is now incomplete.
Clearing data from a form
To clear data from an entire form:
1
Navigate to the form that you want to clear.
2
From the Select Action drop-down list, select Clear CRF.
3
Click Apply.
The Reason for Clearance page appears.
4
In the Reason for clearing the form drop-down list or text box, select or type a reason for
clearing.
5
Click Submit.
The color of each item row background changes from gray to yellow, to indicate that the
item is now incomplete.
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Chapter 8 Updating form data
Deleting or undeleting an itemset
To remove data from an itemset, you can do one of the following:
•
Clear a single item.
•
Delete an entire row before it is submitted.
•
Delete an entire row after it has been submitted.
Deleting an itemset
Note: To clear an entire row of an itemset, do not use the reset value icon (located next to
each data item). To remove a row from an itemset, you must delete the row. The audit trail
for each item indicates that data has been removed by clearing or deleting.
To delete an itemset before submission:
1
Click Return.
A warning appears, informing you that data has not been submitted.
2
To confirm that you want to leave the form without submitting the data, click OK.
To delete an itemset after submission:
126
1
Navigate to the form that contains the itemset that you want to delete.
2
Click the underlined row number.
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The Data Value(s) page for the selected itemset row appears.
InForm 4.6 SP3
3
In the Reason for change drop-down list or text box, select or type a reason for the deletion.
4
Click Delete.
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Chapter 8 Updating form data
After you delete a row, the entries in all columns are crossed out, and the columns are
colored gray to indicate that all items in the row are complete.
Undeleting an itemset
To undelete an itemset:
1
128
Navigate to the form that contains the itemset you want to undelete.
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2
InForm 4.6 SP3
Click the underlined row number.
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Chapter 8 Updating form data
The Data Value(s) page appears, displaying the itemset row that you selected.
3
In the Reason for change drop-down list or text box, select or enter a reason for undeleting
the itemset row.
4
Click Undelete.
A confirmation dialog box appears.
5
Click OK.
The InForm application reinstates the entries in all columns of the row, and the color of
each column reflects the state of the item before the row was deleted.
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What to do if...
The new data item value results in a query
If the value to which you change a data item fails an edit check on that item, the InForm
application generates an automatic query, which you can answer right away by using one of the
following methods:
•
Changing the data value again.
To use this method:
1
Check that the value was entered correctly.
2
Check that the value matches your source data.
3
Check the study documents, including form help, if it is available, to find the range of
permitted values for the item.
If you find that the data is in error, change the data.
4
•
Click the current item value, and proceed as described in Updating form data (on page
115).
Entering answer text.
To use this method, follow the instructions in Answering queries (on page 133).
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131
CHAPTER 9
Answering queries
In this chapter
Overview: Answering queries ........................................................................................................... 134
Answering a query .............................................................................................................................. 138
What to do if... .................................................................................................................................... 143
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133
Chapter 9 Answering queries
Overview: Answering queries
The InForm application allows two methods for creating queries:
•
Automatic queries—Generated when you submit data in an item with an automated server
side edit check, and the data value fails the edit check. The query appears on your screen as a
result of the data submission, and you can see and correct it immediately.
•
Manual queries—Created by CRAs, Clinical Data Managers (CDMs), or other personnel
during source verification or other data review.
Query status
A query can have any of the status codes listed in the following table.
Query status
Description
Candidate
Queries that are visible only to sponsor personnel; they are invisible to site
users. A sponsor representative reviews the query and then either opens or
deletes it.
Opened
Queries that are visible to site users and are awaiting response.
Answered
Queries for which a response has been submitted by a site user. For
manual queries, when a site user responds to a query, the query enters
Answered status and is ready for review by the Clinical Data Manager or
CRA. The Clinical Data Manager or CRA reviews Answered queries and
either closes or reopens them.
Closed
Queries that have been answered by a site user and then reviewed by a
Clinical Data Manager or CRA. If the Clinical Data Manager or CRA is
satisfied with the query answer, he or she closes the query.
Appearance of items with queries
An Opened query on a form item looks like this:
•
The background color of the form item is pink.
•
The text of the query is red in color and begins with the word "Open". The text is located
underneath the form item.
•
A yellow query flag appears in the far right column of the item.
Query Listing
The Query Listing displays a summary of all queries and provides links to the form items against
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which the queries are written.
To view the Query Listing:
•
In the Navigation pane, click Queries.
To display details about a specific query:
•
InForm 4.6 SP3
Click the underlined form name or item number.
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Chapter 9 Answering queries
Queries page
The Queries page displays details about a query and enables you to enter an answer.
To display the Queries page for a specific form item:
•
From the form, click the underlined query text or the query flag.
•
From the Query Listing, click the underlined query text.
Ways to answer queries
You can answer a query in either of the following ways:
•
By changing the data value of the item on which the query was created.
•
By submitting text that explains the data value.
By changing the data value
When you submit a new data value, the InForm application:
•
136
Runs all automated edit checks that exist on the form item. If the new value fails the edit
InForm 4.6 SP3
Step by Step for CRCs and CRAs
checks, the InForm application generates new queries; if the new value passes all edit checks,
the InForm application closes the query.
•
Closes all manual queries on the item, if your trial is configured to close queries automatically
when the data value changes. The audit trail for the item shows that the user who edited the
item closed the query.
•
Updates the appearance of the form item to indicate the new query state.
By submitting text
When you submit text to answer the query, the InForm application:
InForm 4.6 SP3
•
Changes the status of the query to Answered. The query must be closed manually by a data
reviewer who has the right to close queries.
•
Updates the appearance of the form item to indicate the new query state. The background
color of an item with an Answered query is gray, and the query text is removed from below
the item.
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Chapter 9 Answering queries
Answering a query
You can answer a query on a form item by changing the data value or by submitting text that
explains the existing data value.
Changing the data value of the item
To answer a query by correcting the data value of the item:
1
In the Navigation pane, click Queries.
The Query Listing page appears. If necessary, filter the list of queries by selecting a particular
patient, query status, or query issuer from the drop-down lists at the top of the page.
2
138
Click the underlined query text for the query that you want to answer.
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The Queries page appears.
3
InForm 4.6 SP3
Click the Data Value(s) tab.
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Chapter 9 Answering queries
The Data Value(s) page appears.
4
Type the new data value and the reason for change.
5
Click Submit.
Submitting answering text
To submit an answer to a query:
1
140
In the Navigation pane, click Queries.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The Query Listing page appears.
InForm 4.6 SP3
2
If necessary, filter the list of queries by selecting a particular patient, query status, or query
issuer from the drop-down lists at the top of the page.
3
Click the underlined query text for the query that you want to answer.
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Chapter 9 Answering queries
The Queries page appears.
142
4
In the Reason area at the bottom of the Queries page, select a reason from the drop-down
list, or select Other and type the answer to the query.
5
Click Submit.
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What to do if...
The new data value results in another query
If the InForm application generates a new automatic query when you answer a query by
changing the item’s data value, you can answer the new query right away by using one of the
following methods:
•
Changing the data value again.
To change the data value again:
•
1
Check that the value was entered correctly.
2
Check that the value matches your source data.
3
Check the study documents, including CRF help, if it is available, to find the range of
permitted values for the item.
4
If you find that the data is in error, change the data.
5
Click the current item value, and proceed as described in Changing the data value of
the item (on page 138).
Entering answer text.
To use this method, follow the instructions in Submitting answering text (on page 140).
A query conflict occurs
Query conflicts can occur if users working on two different copies of a trial change either the
text or the state of a query before the first user’s change is synchronized to the other user’s
computer.
For more information, see Synchronizing a Trial (on page 265).
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CHAPTER 10
Indicating source verification readiness
In this chapter
Overview: Indicating that a form is ready for source verification .............................................. 146
Marking forms SV Ready or Not SV Ready .................................................................................. 147
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Chapter 10 Indicating source verification readiness
Overview: Indicating that a form is ready for source
verification
You can mark a form to indicate that it is ready or not ready for source verification. This
information is used by monitors to determine which data is ready to be reviewed and source
verified.
Forms can be marked as follows:
•
•
Not SV Ready—A form has this status:
•
After it has been touched (after you enter data in any item or enter a comment to
indicate that the form or a data item will be left blank) and before you mark it SV Ready.
•
If you mark the form ready for source verification, but then change the data in an item,
the InForm application changes the status of the item to Not SV Ready.
SV Ready—A form has this status after you mark it ready for source verification and before
a monitor performs source verification on the form.
Note: To mark a form ready for source verification, you must have the appropriate rights.
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Marking forms SV Ready or Not SV Ready
To mark a form SV Ready or not Ready:
1
In the Navigation pane, click Patients.
2
In the Case Books List, click the traffic light icon for the patient and visit you want to use.
3
Click the tab for the form.
4
In the Select Action list, choose an action.
5
•
To indicate that the form is ready for source verification, click Mark SV Ready.
•
To indicate that the form is not ready for source verification, click Mark Not SV Ready.
Click Apply.
The form does not change appearance. However, the Select Action list changes to include
the opposite SV readiness command; for example, if you marked the form SV Ready, the list
includes the Mark Not SV Ready command. When the monitor views the Source
Verification Listing page, the SV status of the form is SV Ready or Not SV Ready, according
to the action you selected.
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Chapter 10 Indicating source verification readiness
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InForm 4.6 SP3
CHAPTER 11
Performing source verification
In this chapter
About performing source verification............................................................................................. 150
Online source verification ................................................................................................................. 151
Source verifying data on an online form ........................................................................................ 152
Ways to access the source verification view of a form................................................................. 154
Accessing the form from a case book ............................................................................................. 155
Accessing the form from the Source Verification Listing page .................................................. 158
Freezing or locking while monitoring ............................................................................................. 163
Source verifying data from a printed listing ................................................................................... 165
The Source Verification Listing page .............................................................................................. 167
Source verification states ................................................................................................................... 169
What to do if... .................................................................................................................................... 170
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Chapter 11 Performing source verification
About performing source verification
You can verify the data that is entered on forms against source documents, and mark the data
items you have verified to indicate that they are complete.
You can perform source verification in the following ways:
150
•
Online (on page 151).
•
From a printed listing (on page 165).
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Online source verification
You can do the following source verification tasks online:
InForm 4.6 SP3
•
Compare CRF data to source documents—During source verification, the InForm
application displays a specialized view of forms.
•
Issue queries where necessary—If your review turns up errors or inconsistencies, you can
navigate directly from the source verification view of the form to the Queries page, so that
you can issue queries.
•
Record the results of your review—The source verification view of a form contains
checkboxes so you can mark the items and forms that you have verified.
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Chapter 11 Performing source verification
Source verifying data on an online form
To perform source verification:
1
In the source verification view of the form, verify each item for which verification is
required. Items that require source document verification have a checkbox and are
deselected.
Note: When you are verifying data for an itemset, one checkbox is used to mark an
entire itemset row as source verified.
2
Handle each item as required, as described in the table:
Action
Do this
To indicate that an item is
source verified
•
For a data item: Select the checkbox that is located in
the left column of the row that contains the item.

To select all checkboxes at once, click the checkmark
that is located at the upper-left corner of the form.

To deselect a checkbox, click the checkmark.
If only a few items still require verification when you
finish with this form, you can select all boxes, then
deselect the checkboxes for those items that still require
verification.
•
For an itemset: Select the checkbox. One checkbox
marks the entire itemset row as source verified.
•
Against an item: Click the query icon that is located in
the far-right column of the row. Items for which there
are queries have a yellow query icon.
•
Against an itemset: Click the itemset row number, then
click the query icon for the item you want.
•
On an item: Click the comment icon that is located in
the far-right column of the row.
•
On an itemset: Click the itemset row number, then click
the comment icon for the item you want.
To review a comment on the
form as a whole
•
Click the form-level comment icon that is located at the
top-right corner of the page.
To review the audit trail
•
Of an item: Click the audit trail icon that is located in
the far-right column of the row.
•
Of a itemset: Click the itemset row number, then click
the audit trail icon for the item you want.
To enter a query
To review a comment
3
Click Submit.
In the Source Verification listing, the SV Status entry changes for each form whose source
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verification state has changed. If a form becomes SV Complete, a checkmark appears next to
the traffic light icon of the form, in the following places:
•
Source Verification Listing.
•
Case Books Listing.
•
Time and Events Schedule.
This checkmark is visible if you are in a rights group with the right to monitor CRFs.
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Chapter 11 Performing source verification
Ways to access the source verification view of a form
When you perform source verification online, you can access the source verification view of
forms from either of the following locations:
•
The Case Books list or Time and Events schedule.
Accessing the source verification view of forms from a case book is useful if you want to
perform source verification on all of the forms that pertain to a single patient.
If your trial is configured to allow it, you can enable SV mode. As you navigate from form to
form, every form appears in source verification view, with a checkbox next to every item
that requires source verification.
For more information, see Accessing the form from a case book (on page 155).
•
The Source Verification Listing page.
On the Source Verification Listing page, you can sort the list of forms by various criteria,
such as by query state, by visit, or by various status indicators. You can use one of the
standard filters or design a custom filter. This is useful if you are performing an interim
analysis, for example. You can select a specific form and look at that form for each patient
in the list. You can filter the list to display only certain kinds of forms, then perform source
verification for that form for each patient in turn.
For more information, see Accessing the form from the Source Verification Listing
page (on page 158).
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Accessing the form from a case book
You can perform source verification on forms that you have accessed by navigating from the
Case Books List, Time and Events schedule, or patient visit.
If your trial is configured to allow it, you can display the forms in SV continuous navigation
mode. You can navigate to any of the forms in the Case Book or Time and Events schedule. All
of the forms are displayed in source verification view. On each form, every item that requires
source verification appears with a checkbox in the left column.
SV mode remains enabled until you disable it by clicking Disable SV Mode, or until you log off.
Note: For you to be able to use this feature, your trial must be configured by the trial
administrator to allow SV Continuous Navigation mode.
To access the Source Verification view of the form:
1
In the Navigation pane, click Patients.
2
In the Case Books List, display the CRF on which you want to perform source verification,
by doing one of the following:
3
•
Click a traffic light that represents the patient visit whose forms you want to source
verify.
•
To display the Time and Events schedule for a patient, click the patient number.
Optionally, you can filter the display for source verification status (on page 156).
Then click the traffic light that represents the appropriate visit and form.
Follow the instructions in the table, based on the button that appears in the Content-specific
pane.
Button
To access the source verification view
Enable SV Mode
1
Click Enable SV Mode.
The text of the button changes to Disable SV Mode
On the form, each item that can be source verified appears with a
checkbox in the left column.
2
Source verify the form. For more information, see Source
verifying data on an online form (on page 152)
3
Click Return.
4
Click a traffic light icon that represents the next form on which
you want to perform source verification.
The form appears with checkboxes for source verification.
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Button
To access the source verification view
Verify
1
Click Verify
The source verification view of the form appears.
2
Source verify the form. For more information, see Source
verifying data on an online form (on page 152)
3
Click Return.
4
Click a traffic light icon that represents the next form on which
you want to perform source verification.
The monitor view of the form appears.
5
Click Verify.
To disable SV mode:
•
In the Content-specific pane, click Disable SV Mode.
Checkboxes no longer appear next to data items.
Filtering for SV status in the Time and Events Schedule
Sponsor users can filter the Time and Events Schedule of a patient to find forms that have the
following source verification status.
•
SV Ready
•
SV Partial
•
SV Complete
These source verification filters can be used in combination with the other filters that appear on
both the Case Books list and Time and Events schedule:
•
Started
•
Incomplete
•
Contain queries
•
Frozen
•
Locked
When you select one or more filters, traffic lights for the forms that match all of your selections
appear highlighted. For example, if you select the Frozen and the SV Ready checkboxes, only
traffic lights for forms that are both Frozen and SV Ready are highlighted. The traffic light for a
form that is SV Ready and not frozen displays as dimmed.
Your filter selections remain in effect as you navigate to Time and Events schedules and forms
for different patients, until you log off.
To filter the Time and Events schedule for Source Verification status:
1
156
If the Time and Events schedule is not displayed, do the following:
InForm 4.6 SP3
Step by Step for CRCs and CRAs
a
In the Navigation pane, click Patients.
b
In the Case Books List, click a patient number.
The Time and Events Schedule appears.
2
In the Time and Events Schedule, select the checkboxes that represent the status of the
forms you want to view.
Traffic light icons that meet the criteria appear highlighted.
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Accessing the form from the Source Verification Listing
page
To display the source verification view of a form:
1
If the Source Verification Listing page is not displayed, do the following:
•
In the Navigation pane, click Monitor.
The Source Verification listing page appears. For more information, see The Source
Verification Listing (on page 167) page.
2
Optionally, filter the list of forms (on page 158).
3
Locate the row that represents the form whose data you want to source verify.
4
In the CRF column, click the abbreviation for the form.
Filtering the Source Verification listing
The Source Verification Listing page displays information about all patients at all sites to which
you have access. The information is displayed in a table, with each row representing one form
that was used at one visit for a single patient.
You can display only the forms on which you want to perform source verification. The Source
Verification Listing includes drop-down lists from which you can choose to display a list of
forms for a specific site and patient. You can also filter the list by source verification state, by
CRF completion state, and by numerous content and status criteria. You can create and save
custom filters.
The table describes the drop-down lists.
158
Drop-down list
Description
Site
Lists all the sites to which you have access. You can select all sites or
choose a specific site.
Patient
Lists patient numbers based on your selection in the Site drop-down list.
•
To display all records from the site(s), select All.
•
To display records for a specific patient, select the patient number.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Drop-down list
Description
Filter
Provides additional filters for the patient records that are listed as a result
of your selections from the Site and Patient drop-down lists.
You can choose any of the following actions:
•
To display all records, leave the Filter drop-down blank (that is,
displaying nothing).
•
To choose a Public filter, select its name from the drop-down list. For
more information, see Public filters (on page 160).
•
To modify a public filter or create a custom filter, click Edit. For more
information, see Custom filters (on page 160).
To use the Site and Patient drop-down lists:
1
From the Site drop-down list, do one of the following:
•
To display a list of forms from a specific site, choose the site name from the list.
The Source Verification listing displays a list of forms for all patients that are at the site
you selected. The Patient drop-down list changes so that it contains a list of patient
numbers from that site.
•
To display a list of forms from all sites, choose All.
The Source Verification listing displays a list of forms for all patients at all sites. The
Patient drop-down list changes so that it contains a list of patient numbers from all sites.
2
From the Patient drop-down list, do one of the following:
•
To display a list of forms for a single patient, choose the patient number.
The Source Verification listing displays a list of forms for the patient.
•
To list forms for all patients, choose All.
The Source Verification listing displays a list of forms for all patients at the site or sites
you chose in the Site list.
3
To apply an additional filter to the list of forms that is displayed, make a selection in the
Filter drop-down list. You can choose a Public filter (on page 160) or a Custom filter (on
page 160) that you created previously.
Public and Custom filters are applied to the list of patient forms that are displayed as the result
of your selections in the Site and Patient drop-down lists.
For example, if you select a specific site, then select a patient number 01-003, a list of forms for
patient 01-003 appears in the Source Verification listing. If you then select the Not Verified
public filter, the list of forms for patient 01-003 is further narrowed to list only those CRFs that
meet the Not Verified criteria.
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Public filters
Use the Filter drop-down list to select a public filter. The table describes the forms that are listed
when you apply the filter.
Public filter name
Displays a list of
Not Complete
CRFs that have been started. On each CRF, one or more
required items are not complete.
Not Verified
CRFs that contain items that are SV required. On each CRF,
every item that is SV required has any status other than SV
complete.
Ready to Verify
CRFs that have required items. On each CRF:
•
All required items are complete.
•
Each required item has one of the following states:

Not SV Ready

SV Ready

Partial SVd
To view details about the filter criteria, click the Edit button.
To make changes, select or deselect the checkboxes, and save the filter as a Custom filter (on
page 160).
Custom filters
Custom filters let you choose the exact characteristics of the forms that you want to display in
the Source Verification listing. You can create a custom filter by editing an existing public filter
and saving it with a new name, or by creating a new filter and specifying all filter criteria.
Custom filters appear only to you in the Filter drop-down list.
Public and Custom filters are applied to the list of patient forms that are displayed as the result
of your selections in the Site and Patient drop-down lists.
For example, if you select a specific site, then select a patient number 01-003, a list of forms for
patient 01-003 appears in the Source Verification listing. If you then select the Not Verified
public filter, the list of forms for patient 01-003 is further narrowed to list only those CRFs that
meet the Not Verified criteria.
To create a custom filter:
1
2
160
In the Filter drop-down list, do one of the following:
•
To modify an existing filter, select the filter name from the list.
•
To create a new filter, select the blank area from the list; that is, make sure that nothing
is selected.
To the right of the Filter drop-down list, click Edit.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The Criteria dialog box appears. By default, all checkboxes are selected.
3
•
To deselect a checkbox, click in the box.
•
To deselect or select all checkboxes in a category, select or deselect the All checkbox.
Select the checkboxes for the criteria that you want the filter to use. You must make at least
one selection in each category.
Note: To list all instances of a common form, select CCRF in the Visit category.
4
To view a summary of your selections, expand the Criteria dialog box by clicking the arrow
) that is located in the lower-right corner, above the Cancel button.
icon (
5
To save the filter, click Save.
6
Provide a name for the filter.
Note: If you started with an existing filter, the name of the filter appears in the dialog
box.
7
To apply the filter without saving it, click Apply.
After you apply the filter, the following occurs:
•
The filter is applied to the list of forms that was displayed at the time you clicked Apply.
•
Patient records that match all of your selections appear.
•
The Criteria dialog box closes.
•
The Filter drop-down list displays one of the following, depending on whether you
started with a public filter or a blank filter name:
•
If you started with a public filter, the name of the filter appears with the words
Public Filter in parentheses, and an asterisk. For example,
Not Complete (Public Filter)*
•
If you started with a blank filter name, the word Custom appears.
To save a custom filter that you applied without saving
You must save the filter immediately after you apply it, or your edits will be lost.
1
The Filter drop-down list displays the filter that you applied. The name of the filter appears
as either of the following:
•
The word Custom
•
The name of the public filter that you edited, followed by the words Public Filter in
parentheses, and an asterisk. For example,
Not Verified (Public Filter)*
2
Click Edit.
The Criteria dialog displays the criteria that is used by the filter.
3
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Click Save.
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Chapter 11 Performing source verification
4
Type a name for the filter, then click Save.
Note: If you make any changes to the criteria and apply the filter before you save it, the
filter appears with the new criteria.
To delete a custom filter:
1
In the Filter drop-down list, select the name of the filter you want to delete.
2
Click Edit.
The Criteria dialog appears.
162
3
Click Delete.
4
In the confirmation dialog box that appears, click OK to confirm the deletion.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Freezing or locking while monitoring
You can freeze or lock multiple forms in one action from the Source Verification Listing page.
Similarly, you can unfreeze or unlock a form that previously was frozen or locked.
To do any of these actions:
1
In the Navigation pane, click Monitor.
The Source Verification Listing page appears.
2
Optionally, filter the list of patient forms.
The Source Verification Listing includes drop-down lists from which you can choose to
display a list of forms for a specific site and patient. You can also filter the list by source
verification state, by CRF completion state, and by numerous content and status criteria.
You can create and save custom filters. For more information, see Filtering the Source
Verification listing (on page 158).
To display entries for a
Select from the
Site
Site list
Patient
Patient list
Source verification status (partially verified, completely verified, SV Status list
not verified, ready for verification, not ready for verification)
CRF data entry status (complete, missing data, missing data and CRF Status list
queries, queries, frozen or not frozen, locked or not locked)
3
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Select the checkbox on the left of each form you want to freeze or lock.
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4
164
Do one of the following:
•
To freeze or lock the forms—Click Freeze or Lock.
•
To unfreeze or unlock the forms—Click Unfreeze or Unlock.
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Step by Step for CRCs and CRAs
Source verifying data from a printed listing
If you do not have access to a computer when you perform source verification, you can print
copies of CRFs. You can then verify the data offline. After you complete your review, do the
following:
•
Log on to the InForm application.
•
Issue queries where necessary.
•
Record the results of your review. Use the source verification view of the CRFs that you
checked.
Printing an SV Report for offline verification
To perform source verification offline, you can print a copy of the forms for a patient:
1
In the Navigation pane, click Monitor.
2
Click the SV Report tab.
The Source Verification Reports page appears.
3
Optionally, to more easily locate a patient, click the column heading of the Site, Patient
Number, or Patient Initials columns to change the sort order.
4
If the report occupies more than one page, use the page indexer control to navigate to the
page containing data for the patient for whom you want to print CRFs.
5
Click Print Preview for the patient for whom you want to print CRFs.
The InForm application displays a ready-to-print view of the first form in the first visit for
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the patient.
6
Display the form or forms you want to print:
•
To generate a report consisting of all forms, click All.
•
To navigate to a specific form, use the navigation buttons in the Content-specific pane
at the bottom of the page.
7
Click Print.
8
Click Return.
The Source Verification Reports appears.
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The Source Verification Listing page
The Source Verification Listing page displays a summary of the CRFs for each patient. You can
use the Source Verification Listing page to:
•
Determine the source verification status (on page 169) and data entry status of forms.
•
Display the source verification view of a particular form.
•
Filter the list of forms.
•
Freeze or lock selected forms.
The Source Verification Listing page displays information about all patients at all sites to which
you have access. The information is displayed in a table, with each row representing one form
that was used at one visit for a single patient.
For example, for patient 01-001, the table lists one row for the CGI form that was used at the
Baseline visit, another row for the DEM form that was used at the Baseline visit, and so on.
Note: The Source Verification Listing page displays each instance of a repeating form as a
separate row. The number of the instance is added to the name of the form: for example,
AE[1], AE[2].
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To display the Source Verification Listing page:
•
In the Navigation pane, click Monitor.
The Source Verification listing page appears.
The Source Verification Listing includes drop-down lists from which you can choose to display a
list of forms for a specific site and patient. You can also filter the list by source verification state,
by CRF completion state, and by numerous content and status criteria. You can create and save
custom filters.
For more information, see Filtering the Source Verification Listing (on page 158).
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Source verification states
On the Source Verification Listing page, the SV Status column shows the following states:
Status
Listing includes
All
All forms in which at least one data item has been touched or a
form-level comment has been added.
SV Complete
Forms for which source verification has been performed on all data
items.
If a user changes a data item or adds a comment to a form that is SV
Complete, the state of the form reverts to SV Partial.
SV Partial
Forms for which source verification has been performed on one or
more items but not all items.
SV Ready
Forms that a user has marked ready for source verification.
Not SV Ready
Forms in which either of the following is true:
Not SVd
InForm 4.6 SP3
•
At least one data item has been touched or a form-level comment
has been added, but that a user has not marked ready for source
verification.
•
A user has marked the form Not SV Ready.
All forms that are not SV Complete.
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What to do if...
A form changes after source verification is complete
If the value of a data item on a form changes or a query is issued against the item after source
verification is complete, the InForm application makes the following changes to highlight the
item so that you can re-verify it:
•
If the value of a data item on a form changes, the InForm application changes the source
verification status of the form to indicate that the source verification is now incomplete. You
can see this change in the Source Verification Listing, and you can use the filter lists to
highlight forms that have an incomplete source verification status.
•
In the source verification view of the form, the following occurs:
•
The checkmark of the item is cleared.
•
The background color of the item changes, as follows.
Item change
Color changes to:
Required item deleted.
Yellow checkbox cell, yellow data cell.
Required item changed.
Yellow checkbox cell, gray data cell.
If you have any unverified items, repeat the source verification procedure.
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CHAPTER 12
Issuing queries
In this chapter
Overview: Issuing queries ................................................................................................................. 172
Issuing a query .................................................................................................................................... 173
Opening a candidate query ............................................................................................................... 178
Deleting a candidate query ................................................................................................................ 181
Navigating between queries and CRFs ........................................................................................... 184
What to do if... .................................................................................................................................... 185
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Chapter 12 Issuing queries
Overview: Issuing queries
This section describes how to issue queries.
Automatic and manual queries
The InForm application provides the capability for both automatic and manual queries:
•
Automatic queries—Issued when a submitted data value fails a predefined edit check.
These queries appear immediately after data submission, and site users can respond to them
before any data review occurs.
•
Manual queries—Issued as a result of review activities. You enter a manual query by using
query pages, site users respond to the queries, and you monitor the responses. The query
procedures described in this chapter deal only with manual queries.
Query states
Your trial can be set up to allow you to issue queries in either or both of the following states:
172
•
Opened—Queries are immediately visible to site users and available for response.
•
Candidate—Queries are preliminary and are invisible to site users. If your trial is set up to
enable Candidate queries, there might be a step in which a senior CRA reviews Candidate
queries before opening them. When you change the state of a Candidate query to Opened, it
becomes visible to site users.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Issuing a query
To issue a query:
1
In the Navigation pane, click Patients.
The Case Books List appears.
InForm 4.6 SP3
2
Click the traffic light icon for the patient and visit in which you want to create a query.
3
Click the tab for the form on which you want to issue a query.
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Chapter 12 Issuing queries
The form appears.
4
Do one of the following:
•
For a regular item—Click the query icon in the farthest-right column of the item for
which you want to create a query.
•
For an item in an itemset or a repeating form instance—Click the itemset or
repeating form instance row number, then click the query icon in the farthest-right
column of the item for which you want to create a query.
The Queries page appears. If the item has no queries, the Queries page is blank. If the item
has at least one query, the most recent query appears.
Note: Your trial may be configured so that when you click the query icon for an item
that has no queries, a blank query form appears; you do not need to click Create Query.
Go to Step 6.
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Note: If you are performing source verification on a CRF, you can navigate to the
Queries page. In the source verification view of the CRF, in the far-right column, click
the query icon.
5
InForm 4.6 SP3
Click Create Query.
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Chapter 12 Issuing queries
6
If you have rights to create a query in either Candidate or Opened state, use the Action
drop-down list to select the state.
Note: If you have only one of these access rights, the state will be preselected.
7
8
For Reason, select or type the query text by doing one of the following:
•
Select the appropriate text from the drop-down control.
•
Select Other and type the reason in the text box.
Click Submit.
The form on which you entered the query appears. The appearance of the item changes as
follows:
•
If you issued an Opened query:
•
The background color of the item changes to pink.
•
The query text appears below the item.
•
The query flag in the far-right column of the item is yellow.
To open the Queries page and view detailed information, click the query text.
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•
If you issued a Candidate query:
•
The query flag turns yellow (if it was not already yellow).
•
The background color and query text do not change until the query status is
changed to Opened by a user with the rights to make that change.
Note: A Candidate query is invisible to site users until the query is opened.
9
In the Navigation pane, click Queries to return to the Queries page.
10 To see the status of all queries on this item, use the Query drop-down list. To choose a
different action, select it from the Action drop-down list.
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Opening a candidate query
To change a candidate query to an opened query:
1
In the Navigation pane, click Queries.
The Query Listing page appears.
2
178
From the Query Status drop-down list at the top of the page, select Candidate. Optionally,
filter the list of queries to display queries for a specific site or patient by using the drop-down
lists.
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Step by Step for CRCs and CRAs
3
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Click the query you want to open.
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Chapter 12 Issuing queries
The Queries page for the item appears.
4
From the Action drop-down list, select Place Query in Opened State.
5
From the Reason drop-down list, select a reason, or select Other and type a reason.
6
Click Submit.
The form reappears with the opened query.
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Deleting a candidate query
To delete a candidate query:
1
In the Navigation pane, click Queries.
The Query Listing page appears.
2
InForm 4.6 SP3
From the Query Status drop-down list at the top of the page, select Candidate. Optionally,
filter the list of queries to display queries for a specific site or patient, by using the
drop-down lists.
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Chapter 12 Issuing queries
3
182
Click the query you want to open.
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Step by Step for CRCs and CRAs
The Queries page for the item appears.
4
From the Action drop-down list, select Delete Query.
5
From the Reason drop-down list, select a reason, or select Other and type a reason.
6
Click Submit.
The form reappears with the opened query.
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Navigating between queries and CRFs
There are links that allow you to navigate between the Query Listing the details of the query and
the form on which the query is located. Use the table below to navigate between these InForm
pages.
184
To navigate from
To the
Click
Query page
Form on which the query was
entered.
Arrow icon.
CRF
Query page.
The underlined text of the
query.
Query Listings page
Query page.
The underlined text of the
query.
Query page
Query Listing.
Return.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
What to do if...
A query conflict occurs
Query conflicts can occur if users working on two different copies of a trial change either the
text or the state of a query before the change made by the first user is synchronized to the
computer used by the other user.
For more information, see Synchronizing a Trial (on page 265).
You expect to see a query, but it is not there
That item is marked as hidden for your user group. If during trial design an individual item is
marked as hidden for your user group and a query appears for that item, the query will not be
visible to you.
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CHAPTER 13
Closing queries
In this chapter
Overview: Closing queries ................................................................................................................ 188
Closing queries .................................................................................................................................... 189
How queries appear to sponsor users ............................................................................................. 192
What to do if... .................................................................................................................................... 193
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Chapter 13 Closing queries
Overview: Closing queries
The InForm application enables closing queries in the following ways:
188
•
Automatic query generated by the failure of an edit check—When a user enters a new
data value that passes the edit check, the InForm application closes the query. If the new
data value fails the edit check, the InForm application redisplays the query. When an
automatic query is answered with explanatory text, the query can only be closed when an
authorized sponsor user closes it.
•
Manual query—When a user submits an answer to a manual query, the InForm application
changes the query state to answered. A sponsor user with query closing rights must close
answered queries manually.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Closing queries
Finding answered queries
You can navigate to an answered query from the Query listing or the Case Book List.
From the Query Listing
To locate an answered query:
1
In the Navigation pane, click Queries.
The Query Listing appears.
2
InForm 4.6 SP3
From the Query Status drop-down list at the top of the page, select Answered. Optionally,
filter the list of queries to display queries for a specific site or patient, by using the
drop-down lists.
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Chapter 13 Closing queries
3
Locate the query that you want to open.
From the Case Books list
To locate an answered query:
1
In the Navigation pane, click Patients. Or, use the Find Patient field to locate a specific
patient.
2
In the Case Books List, click the patient number for a patient who has one or more traffic
lights displayed with a yellow flag.
3
In the case book, click a traffic light icon that displays a yellow flag.
The form that contains the answered query is displayed.
Closing the query
To close an answered query:
1
190
Click the underlined text of the query.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The Queries page for the item appears.
2
Review the appropriateness and validity of the answer.
3
From the Action drop-down list, select Close Query.
4
From the Reason drop-down list, select a reason, or select Other and type a reason.
5
Click Submit.
The InForm application updates the status of the query. The Queries and Query Listing
pages show the updated status.
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How queries appear to sponsor users
Opened and Answered queries differ in appearance.
Opened queries
An Opened query on a form item looks like this:
•
The background color of the form item is pink.
•
The text of the query is red in color and begins with the word "Open". The text is located
underneath the form item.
•
A yellow query flag appears in the far right column of the item.
Answered queries
An Answered query looks like this:
•
The background color is pink.
•
The text of the query is black in color and begins with the word "Ans'd".
To view query details, click the red arrow that is located to the right of the query text. The query
expands to show the following information:
192
•
The date that the query was answered.
•
The name of the person who answered the query.
•
The answer to the query.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
What to do if...
The answer to a query is unacceptable
If a response to a query does not resolve the issue that the query points out, you can reissue the
query as follows:
1
Navigate to the Query page for the item you are reviewing, as described in Closing a query
(see "Closing the query " on page 190).
2
From the Action drop-down list, select Reissue Query in Open State.
3
From the Reason drop-down list, select a reason for reopening the query, or select Other and
type a reason.
4
Click Submit.
A query conflict occurs
Query conflicts can occur if users working on two different copies of a trial change either the
text or the state of a query before the change made by the first user is synchronized to the
computer used by the other user.
For more information, see Synchronizing a Trial (on page 265).
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CHAPTER 14
Working with multiple queries
In this chapter
Overview: Working with multiple queries ...................................................................................... 196
Closing or reissuing a set of answered queries............................................................................... 197
Opening or deleting a set of candidate queries.............................................................................. 200
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Overview: Working with multiple queries
You can perform an action on a set of selected queries by using a special view of the Query
Listing page. The Query Listing has two modes in which to view the list of queries: list view and
action view.
•
List view mode—The list view mode of the Query Listings page allows you to view the
details of all the queries, or a filtered list of queries.
•
Action view mode—While in action view mode, you can perform one action on a specified
set of queries, and apply the same reason for change to all these queries. The Action View
button is not available until a status other than All is selected in Query Status.
Note: You can change the display from the action view to the list view by clicking the List
View button when in action view and clicking the Action View button when in list view.
When you are in action view mode, you can perform the following actions:
196
Query Status filter on Query Listings page
Available actions on selected queries
Answered
Reissue or close query.
Candidate
Open or delete query.
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Step by Step for CRCs and CRAs
Closing or reissuing a set of answered queries
To close or reissue a set of answered queries:
1
In the Navigation pane, click Queries.
The Query Listing appears.
2
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In Query Status, select Answered.
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Chapter 14 Working with multiple queries
3
198
Click Action View.
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A checkbox appears to the left of each query, and the Action and Reason fields appear at the
bottom of the page.
4
Click the checkboxes to the left of the queries with which you want to work.
Note: To select all queries at once, click the check Select all checkboxes icon that is
located at the top of the page (
).
InForm 4.6 SP3
5
For Action, select the action you want to perform. The rights you have as a user of the
InForm application determine the actions that appear.
6
For Reason, select a reason from the drop-down list, or type a reason for the change.
7
Click Submit.
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Chapter 14 Working with multiple queries
Opening or deleting a set of candidate queries
To open or delete a set of candidate queries:
1
In the Navigation pane, click Queries.
The Query Listing appears.
2
200
In Query Status, select Candidate to filter only the candidate queries.
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3
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Click Action View.
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Chapter 14 Working with multiple queries
A checkbox appears to the left of each query and the Action and Reason fields appear at the
bottom of the page.
4
Select the checkboxes to the left of the queries with which you want to work.
Note: To select all queries at once, check Select all checkboxes icon at the top of the
page (
).
202
5
For Action, select the action you want to perform. The rights you have as a user of the
InForm application determine which actions appear in the drop-down list.
6
For Reason, select a reason from the drop-down list or enter a textual reason for the change.
7
Click Submit.
InForm 4.6 SP3
CHAPTER 15
Freezing, unfreezing, locking, and unlocking
In this chapter
Overview: Freezing and locking....................................................................................................... 204
Freezing or locking a form................................................................................................................ 206
Freezing or locking several forms at once ...................................................................................... 208
Freezing or locking a case book ....................................................................................................... 213
Freezing or locking with synchronization ...................................................................................... 214
What to do if... .................................................................................................................................... 216
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Chapter 15 Freezing, unfreezing, locking, and unlocking
Overview: Freezing and locking
Freezing and locking data enables you to prevent changes in forms, either temporarily during a
study or permanently at the end of a study.
You can freeze and lock:
•
Forms
•
Visits
•
Case Books
Note: You can freeze or lock only a form in which a user has entered at least one data item or
comment. If you freeze or lock a Case Book, freeze or lock icons appear only on started
forms; however, all forms in the Case Book are frozen or locked. The activities that are
allowed or not allowed, as listed in the following table, pertain to all forms.
When you freeze or lock a form or Case Book, the following rules are in place:
Activity allowed?
CRF frozen
Case Book
frozen
CRF locked
Case Book
locked
Add/update
patient data
No unless allowed.*
No, unless
allowed.*
No.
No.
Add/update
comments
No unless allowed.*
No, unless
allowed.*
No.
No.
Open queries
No unless allowed.*
No unless
allowed.*
No.
No.
Answer queries
Yes, but can change
data value only if
allowed.*
Yes, but can
change data
value only if
allowed.*
No.
No.
Close queries
No unless allowed.*
No unless
allowed.*
No.
No.
Mark SV ready
Yes.
Yes.
No.
No.
Source verify
No unless allowed.*
No unless
allowed.*
No.
No.
Sign CRF
Yes.
Yes.
Yes.
Yes.
Sign case book
Yes.
Yes.
Yes.
Yes.
*Sponsor users can perform this activity only if the trial has been configured to allow sponsor users
to update forms after they are frozen.
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Freezing and locking icons
When you freeze or lock a form or case book, a freeze icon (snowflake ) or a lock icon
(padlock ) appears next to the CRF or case book traffic lights on the Case Books List, Time
and Events Schedule, Source Verification Listing, and Required Signatures form.
If a form or case book is both frozen and locked, both icons appear next to its corresponding
traffic light.
Freezing, locking, and synchronization
If you are using the InForm Unplugged software module to synchronize data between users who
are working offline (that is, they have their own copy of the trial and are not connected at all
times to a central computer through a browser), freezing and locking perform the same functions
as described in this section. However, the timing of when freezing and locking takes effect
during synchronization is different from the timing described in this section.
For more information, see Freezing and locking with synchronization (see "Freezing or
locking with synchronization " on page 214).
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Chapter 15 Freezing, unfreezing, locking, and unlocking
Freezing or locking a form
To freeze, unfreeze, lock, or unlock a single form:
1
Navigate to the form you want to freeze, unfreeze, lock, or unlock.
The buttons you see at the bottom of the form depend on the rights you have been assigned
and the state of the form. For example, if you have the right to freeze a form but not to lock
it, only the Freeze button is present.
The Freeze/Unfreeze buttons, and the Lock/Unlock buttons are toggles. Only one of each
pair is present, depending on the state of the form. For example, if a form is not frozen, the
Freeze button is present, but the Unfreeze button is not present. If the form is frozen, the
Unfreeze button is present. Similarly, if a form is unlocked, the Lock button is present. If a
form is locked, the Unlock button is present.
2
206
Click one of the following:
•
Freeze
•
Unfreeze
•
Lock
•
Unlock
InForm 4.6 SP3
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Note: When you freeze, unfreeze, lock, or unlock a common form, the InForm application
updates the traffic light icon that represents the form in the Time and Events Schedule in all
visits where the form occurs. However, the traffic light icon for a common form in an
unscheduled visit is not updated until a user creates at least one unscheduled visit.
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Freezing or locking several forms at once
You can freeze, unfreeze, lock, or unlock several forms at one time:
To freeze, unfreeze, lock, or unlock
Use the buttons on
All forms in a visit.
Any view of the form.
Selected repeating form instances.
The Summary view of the form.
Any selected forms.
The Source Verification Listing page.
All forms in a visit
To freeze, unfreeze, lock, or unlock all forms in a visit:
208
1
Navigate to any form within the desired visit.
2
In the Select Action drop-down list, click one of the following:
•
Freeze Visit—To freeze
•
Unfreeze Visit—To
•
Lock Visit—To
all forms in the visit.
unfreeze all forms in the visit.
lock all forms in the visit.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
•
Unlock Visit—To
unlock all forms in the visit.
Note: The selections in the Select Action list depend on the rights you have been
assigned. For example, if you have the right to freeze a visit but not to lock it, only the
Freeze Visit and Unfreeze Visit selection are present.
3
Click Apply.
A message appears, indicating the number of forms that were affected. Additionally, freeze
or lock icons are added or removed as follows.
Action
Changes to the display of icons
Freeze Visit
In the Time and Events Schedule, the freeze icon appears next to the
traffic light for each non-common, started CRF in the visit. The freeze icon
also appears next to the traffic light for the visit in the Case Books List.
Unfreeze Visit
The InForm application removes the freeze icons from the non-common
forms in the Time and Events Schedule. The InForm application also
removes the freeze icon from the visit in the Case Books List.
Lock Visit
In the Time and Events Schedule, the lock icon appears next to the traffic
light for each non-common, started CRF in the visit. The lock icon also
appears next to the traffic light for the visit in the Case Books List.
Unlock Visit
The InForm application removes the lock icons from non-common forms
in the Time and Events Schedule. The InForm application also removes
the lock icon from the visit in the Case Books List.
Note: When you freeze, unfreeze, lock, or unlock a visit, the status of any common forms in
the visit does not change. Freeze, unfreeze, lock, or unlock a common form at the form or
case book level.
Selected repeating form instances
You can use the Summary view (on page 50) of a repeating form to select multiple instances of
the form and freeze, unfreeze, lock, or unlock them.
To perform one action on several instances of a form:
1
InForm 4.6 SP3
Navigate to the summary view of a repeating form.
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Chapter 15 Freezing, unfreezing, locking, and unlocking
2
While in summary view, click the action button you want to perform:
•
Freeze—To freeze
•
Unfreeze—To
•
Lock—To
•
Unlock—To
form instances.
unfreeze form instances.
lock form instances.
unlock form instances.
The summary view reappears with a column of checkboxes along the left side.
3
Select the box next to each form instance on which you want to perform the action you
selected in step 2.
4
Click the button for the action you selected:
•
210
Freeze—To freeze
the selected form instances.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
•
Unfreeze—To
•
Lock—To
•
Unlock—To
unfreeze the selected form instances.
lock the selected form instances.
unlock the selected form instances.
The InForm application adds or removes freeze or lock icons next to the traffic light for
each form instance you selected. It also adds or removes icons on the Time and Events
Schedule and the Case Book List to reflect the actions you have taken.
While monitoring
You can freeze or lock multiple forms in one action from the Source Verification Listing page.
Similarly, you can unfreeze or unlock a form that previously was frozen or locked.
To do any of these actions:
1
In the Navigation pane, click Monitor.
The Source Verification Listing page appears.
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Chapter 15 Freezing, unfreezing, locking, and unlocking
2
Optionally, filter the list of patient forms.
The Source Verification Listing includes drop-down lists from which you can choose to
display a list of forms for a specific site and patient. You can also filter the list by source
verification state, by CRF completion state, and by numerous content and status criteria.
You can create and save custom filters. For more information, see Filtering the Source
Verification listing (on page 158).
To display entries for a
Select from the
Site
Site list
Patient
Patient list
Source verification status (partially verified, completely verified, SV Status list
not verified, ready for verification, not ready for verification)
CRF data entry status (complete, missing data, missing data and CRF Status list
queries, queries, frozen or not frozen, locked or not locked)
212
3
Select the checkbox on the left of each form you want to freeze or lock.
4
Do one of the following:
•
To freeze or lock the forms—Click Freeze or Lock.
•
To unfreeze or unlock the forms—Click Unfreeze or Unlock.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Freezing or locking a case book
To freeze, unfreeze, lock, or unlock a case book:
1
Go to the Time and Events Schedule for a patient
2
Click one of the following:
•
Freeze Book.
•
Unfreeze Book.
•
Lock Book.
•
Unlock Book.
Note: You can freeze a case book that includes forms that were frozen previously.
When you unfreeze or unlock a case book, the InForm application unfreezes or unlocks all
previously frozen or locked forms.
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Chapter 15 Freezing, unfreezing, locking, and unlocking
Freezing or locking with synchronization
When you freeze or lock a form or case book in an environment when data is being
synchronized across multiple copies of a trial—for example, if some CRAs are working
unconnected to a network and then updating a central computer with their changes—the timing
of when each CRA freezes or locks items becomes important.
Each time patient data is added or updated, the InForm application associates the data with the
current date and time. If users update the same data item for the same patient on different copies
of the trial, the software must determine which value is the current value when the trial
information is synchronized. It uses the date and time to make the determination and follows the
rule that the latest value is the current one and is displayed on all copies of the trial after
synchronization.
Just as the same data could be updated at different times because one user does not know what
another is doing on a different copy of the trial, a conflict could occur over the timing of
freezing and locking. Consider the following scenario:
At noon, a CRA using the InForm application on a laptop that is not connected to the network
freezes the DEM form for Patient A. At 12:15, a CRC connected to a site through a browser
changes a data item on the DEM form. Because the site computer does not know about the
freeze, the change goes through. When the CRA synchronizes with the site computer, the
InForm application must handle the fact that the data item was changed after the form was
frozen.
The InForm application resolves timing differences in freezing, locking, and data entry and
update activities by using the rule that freezing and locking actions do not apply until the freeze
or lock is synchronized throughout the entire trial. After a freeze or lock, activities that affect
data continue to be accepted from all users until the form or case book is frozen or locked on
every copy of the trial. This prevents data from being lost because the computer it was entered
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on did not yet know about the freeze or lock.
Note: This rule applies only in an environment where synchronization is taking place between
computers that are running different copies of the trial; in an environment where everyone
connects to a single server through a browser, freezing and locking takes effect immediately.
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Chapter 15 Freezing, unfreezing, locking, and unlocking
What to do if...
Data changes after freezing or locking
If a new or changed result comes in on a patient whose form is frozen or locked:
216
1
Contact a sponsor representative who is authorized to unfreeze or unlock the form.
2
Update the appropriate form or forms.
3
Notify the sponsor representative when the addition or update is complete.
InForm 4.6 SP3
CHAPTER 16
Signing forms
In this chapter
Overview: Signing forms ................................................................................................................... 218
Signing a CRF or case book.............................................................................................................. 222
Viewing signature status .................................................................................................................... 226
Viewing signature details ................................................................................................................... 228
What to do if... .................................................................................................................................... 229
InForm 4.6 SP3
217
Chapter 16 Signing forms
Overview: Signing forms
This section describes concepts of which you should be aware when signing a form or Case
Book.
Significance of a signature
Generally, signing a form or case book is done with the expectation that the form or case book is
complete, and data is not expected to change. The exact significance of a signature can vary from
trial to trial; for example, a Principal Investigator (PI) could sign a form to indicate responsibility
for the accuracy and completeness of the data, and a CRA could sign the same form to indicate
that the review is complete. Additional meanings of a signature could include authorship or
approval of a form.
The language of the affidavit page on which a signer enters signature information indicates what
the signature is intended to convey. A brief definition or summary of the affidavit might appear
in the meaning column of the signature section on all forms that require signatures.
Form and case book signatures
The InForm application enables trials to be configured so that your signature is attached to a
single form, several forms, or an entire case book. For example, a trial could be configured to
require a signature on certain key forms for each patient and also to require a signature on the
case book for each patient.
When a trial is set up, specific forms are designated as signing CRFs. Additionally, if signing is
required for a complete case book, a single form is designated as the signing CRF for the case
book.
218
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List of required signatures
A list of required and applied signatures is displayed on the electronic, printed and PDF versions
of a form. For a signed case book, the list of signatures is displayed on the CRF that is
designated as the case book signing CRF.
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Chapter 16 Signing forms
Signature groups
The InForm application uses the mechanism of signature groups to manage trial-specific
requirements about who must sign a form or case book. During trial set-up, users who have
rights to sign forms or case books are assigned to signature groups. A signing form is designated
as requiring signature by a member of one or more signature groups. The meaning of the
signature is included in the definition of the signature group.
For example, if both a PI and a CRA must sign a CRF, the trial can be set up so the PI is a
member of the Responsible Party signature group, and all CRAs are members of the Reviewer
signature group. A signing CRF requires signature by a member of the Responsible Party signature
group (the PI) and the Reviewer signature group (any authorized CRA).
The InForm application tracks the forms signing status, and displays a list of required and
applied signatures at the bottom of each form requiring signatures.
The Signature Status Details form provides details about signature status, the meaning of the
signature, and the date which the form was signed. The Machine Name column displays the
computer with which the user was logged on when signing.
Invalidation of signature by data update or query
When a form or case book is signed, it is expected that data entry is complete, source verification
has been performed, and all queries are resolved and closed. However, later information can
result in data entry changes or new queries after the form or case book has been signed.
When this happens, InForm application invalidates the previous signature or signatures and
updates the signature listings and each form to indicate that the form or case book must be
signed again.
Data that has been exported from InForm application by using AutoCode or Central Coding
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functionality and reimported after coding has special invalidation considerations. Coded data is
often designed to be hidden on a form; if the import of coded data invalidates a signature, it
might not be possible to see which item caused the invalidation. Therefore, study designers can
specify whether imported data invalidates a signature.
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Chapter 16 Signing forms
Signing a CRF or case book
The procedures for signing a CRF or a case book are the same, with the following exceptions:
•
To sign a case book, you sign the form designated as the form on which a signature
represents a signature on the entire case book.
•
The buttons and controls used to sign a form and a case book are labeled differently; you
can access the form signature page from a Sign button or link, but you access the case book
signature page from a Sign Book button or link.
Before you can sign a CRF, the following conditions must be true:
•
The CRF is set up as a signing form.
•
You have the right to sign CRFs.
•
You are in the same signature group as the CRF.
•
No other user in the signature group has already signed the CRF.
•
The CRF has at least one data item entered.
Before you can sign a case book, the following conditions must be true:
•
A CRF has been set up as the form used to sign case books.
•
You have the right to sign case books.
•
You are in the same signature group as the case book.
•
No other user in the signature group has already signed the case book.
•
At least one data item is entered in the final CRF of the case book.
To sign a CRF or case book:
1
222
In the Navigation pane, click Signatures.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The Required Signatures page appears.
2
InForm 4.6 SP3
Use the drop-down lists at the top of the page to select the CRF or case book signing
information you need. The following table summarizes the criteria you can select. In addition
to these selection criteria, you can select All to display all forms or case books in the
category.
To display forms or case books for a …
Select from the …
Site.
Site list. This list is visible if you have rights to
view information for more than one site.
Patient.
Patient list.
CRF or case book signature.
Type list.
Signing status (signed or unsigned).
Status list.
Form or case book completion status (All, All
Signatures Complete, Not All Signatures
Complete, With Queries, With Missing Values,
Missing & Queries, Frozen, Locked, Ready for
SV, Completed SV, SVed and Complete,
Complete, Not Done, Deleted).
CRF/Book status list. Note that the InForm
application ignores filters that do not apply to
the selected Type. For example, if you select
case book from the Type list and select Ready
for SV in the CRF/Book status list, the
InForm application ignores the Ready for SV
filter, since SV readiness applies only at the
CRF level.
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Chapter 16 Signing forms
Note: Use the page indexer control to navigate through multiple pages of the Required
Signatures page.
3
Click the Sign or Sign Book link for the form you want to sign.
The signing affidavit appears.
4
Read the affidavit. In the User name and Password boxes type your InForm application
username and password.
Note: You need to enter both username and password only the first time you sign the
form during an InForm session. If you need to re-sign a form because of intervening
activity that causes the form to become unsigned, enter only your password.
5
224
Click Submit.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The InForm application updates the signing status on the Required Signatures page, on the
Signature Status Details page, and on the CRF.
Note: Another way to access the signing affidavit for a signing CRF, without going
through the Required Signatures list, is to click Sign CRF on the signing CRF. Another
way to access the signing affidavit for the CRF designated for signing case books is to
click Sign Book on the Time and Events Schedule or on the form.
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Chapter 16 Signing forms
Viewing signature status
To review signature status, use the Required Signatures page. Two versions of this page are
available:
•
My signatures
•
All signatures
My signatures
This version of the Required Signatures page displays the signature status of CRFs and case
books that require signature by a member of your signature group. This version is available and
is the default view if you have been assigned the right to sign CRFs or case books and you are a
member of a signature group. In this version, Signature column indicates the signing status of the
CRFs or case books for which your signature group is responsible.
To review signatures by using this version of the Required Signatures page:
226
1
In the Navigation pane, click Signatures.
2
Optionally, filter the list of documents that require signatures by using the desired
drop-down lists.
3
Review the Signature column. The icon or signing link indicates the signing status of the
document.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
All signatures
This version of the Required Signatures page displays the signature status of CRFs and case
books by site, regardless of the signature group that must sign them. This version is available if
you have been assigned the right to view CRF or case book signature information. You can
display this version of the page if you have both signing and viewing rights. In this version, the
All Signatures column in the required signatures table indicates the signing status of all CRFs and
case books for the site.
To review signatures by using this version of the Required Signatures page:
InForm 4.6 SP3
1
In the Navigation pane, click Signatures.
2
Click View All Signatures.
3
Optionally, filter the list of signature-requiring documents by using the desired drop-down
lists.
4
Review the All Signatures column. The icon or signing link indicates the signing status of the
document.
227
Chapter 16 Signing forms
Viewing signature details
228
1
In the Navigation pane, click Signatures.
2
Optionally, to filter the list of documents that require signatures, use the drop-down lists.
3
In the Details column of the list, click the View link for the patient and CRF or case book for
which you want to review signature history.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
What to do if...
A form changes after signature
If it is necessary for a query to be issued or a data update to be made after a form has been
signed, the InForm application automatically invalidates the previous signature or signatures and
resets the signing status as follows:
•
Single signed CRF—The InForm application sets the signing status to unsigned, and the
form must be re-signed by all required signature authorities, often after the appropriate
source verification and query resolution activities.
•
Signed CRF in a signed case book—If a user enters data in a CRF that requires individual
signature, the InForm application sets the signing status of the CRF to unsigned, and the
CRF must be re-signed by all required signature authorities, after the appropriate source
verification activity. Additionally, the signing status of the case book is set to unsigned, and
the case book must be signed again.
•
Unsigned CRF in a signed case book—If a user enters data in any CRF that does not
require signature, the InForm application sets the signing status of the case book to
unsigned, and the case book must be re-signed after the appropriate source verification
activity. If the case book also contains individually signed CRFs, those CRFs are not
considered unsigned and do not need to be re-signed.
The Sign or Sign Book link for the form reappears in the Signature column of the Required
Signatures page. The Signature Status Details page maintains an audit trail on the previous
signatures, and the message at the top of the page indicates the signature groups from which a
member must re-sign the form.
When a signature is invalidated and must be obtained again, follow the steps in Signing a CRF
or case book (on page 222) to repeat the signing process.
Your signature fails processing
If you enter an incorrect user name or password while signing, try to re-enter your user name
and password, just as you would when logging on to the InForm application. You have the same
number of tries as you would when you log on; this number is set up for your trial.
If you fail to enter the correct user name and password after the configured number of tries, the
InForm application logs you out and inactivates your user account. To be reinstated, you must
contact the system administrator for your trial.
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Chapter 16 Signing forms
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InForm 4.6 SP3
CHAPTER 17
Printing
In this chapter
Printing a CRF .................................................................................................................................... 232
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Chapter 17 Printing
Printing a CRF
To print a CRF:
232
1
Navigate to the CRF you want to print.
2
In the Select Action drop-down list, select Print Preview, and then click Apply.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The InForm application displays a preview of the CRF.
3
Click Print.
For more information, see Printing an SV Report for offline verification (on page 165).
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Chapter 17 Printing
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InForm 4.6 SP3
CHAPTER 18
Generating data listings
In this chapter
Overview: Data listings...................................................................................................................... 236
Generating listings .............................................................................................................................. 237
What to do if... .................................................................................................................................... 244
InForm 4.6 SP3
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Chapter 18 Generating data listings
Overview: Data listings
Listings enable you to take a snapshot of patient data and download it. Downloaded listings are
in a file of comma-separated values (a CSV file) that you can open in a Microsoft Excel
spreadsheet or in another program that reads CSV files.
You choose the sites and the data items you want to capture, and the InForm application
generates a listing of each data item for each patient in the database. After generating a listing,
and opening it in a Microsoft Excel spreadsheet, you can navigate back from the spreadsheet to
the CRF that is the source of the data.
If you need to generate the same selection of data items multiple times, you can save the
selection and recall it at a later date to run again.
Note: To generate data listings, you need the Data Export Listings right in InForm
Administration.
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Generating listings
Creating a new listing
To create a listing:
1
In the Navigation pane, click Listings.
The Listings Export Tool window appears.
2
InForm 4.6 SP3
Select listings options by using the checkboxes at the top of the page:
Select this option
To
Global Save
Allow any user with the right to generate listings to open a saved
listing definition. If you do not select this option, only you can
view a listing definition that you have saved.
HTTP Links
Generate links that enable you to click a cell in Microsoft Excel
spreadsheet created from a listing and navigate back to the form
and data item in the InForm application.
Comments
Include comments as well as data items in the listing.
3
From the Site list, select the site for which you want to run the listing. The default is All
Sites.
4
In the list of forms and form items, select the checkbox at the left of each item for which
you want to generate a listing.
5
Each form includes a set of checkboxes indicating the visits in which the form occurs in the
Time and Events Schedule. Select each visit for which you want to extract the items you
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selected in the previous step.
Tips:
6
•
To specify that you want all visits in which the form occurs, select the All checkbox.
•
To select all item and visit checkboxes at once, click the check button
in the upper-left corner of the pane.
•
To clear the Listings Extract Tool page of all data selections, click New.
that is located
Click Generate.
As the listing runs, the InForm application displays the progress of the listing as a percentage
of completion.
When the listing is complete, the InForm application displays a window instructing you to
click Download or Delete:
•
To download the listing to a Microsoft Excel Comma Separated Values (CSV)
file:
Click Download.
The InForm application displays a message box prompting you to save the extracted
data file on your local computer or specify that you want to open it without saving it.
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Note: If you do not have Microsoft Excel on your computer, do not open the file
(do not click Open).
In this message box, click Save, and in the dialog box that appears, specify where you
want it saved.
•
To delete the listing:
Click Delete.
7
If you chose Download, when the file finishes downloading to the specified folder, you can
open it with Microsoft Excel from the folder where you saved it.
In the spreadsheet, each column contains the value of the patient data for one of the data
items you selected. The column heading identifies the data item and the visit and form it
comes from.
Note: If Microsoft Excel is not installed on your computer, when you open the file from
the folder where you saved it, the file opens as a comma-separated text file in the
application to which .csv files are mapped in your Microsoft Windows Folder Options.
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Saving a listing specification
If you expect to generate the same data listing multiple times, you can save the listing
specification and run it later using the name you give it.
To save a listing specification:
1
2
Create a new listing (see "Creating a new listing " on page 237), but do not generate the
new listing.
Click Save or Save As.
A dialog box appears so that you can specify a name for the listing specification.
3
Type a name for the listing specification in the text box.
4
Click OK.
After you save the listing specification, you can do either of the following:
•
Click Generate to generate the listing.
•
Open it (see "Opening a saved listing specification " on page 240) at any later time to
generate the same information without having to re-specify it.
Note: You can create a listing specification, open it, refine it, and save it under another
name by using the Save As button.
Opening a saved listing specification
After you have saved a listing specification, you can open and run it at any time.
To open a saved listing specification:
1
In the Navigation pane, click Listings.
2
In the Listings Report list at the bottom of the page, select the listing specification you want
to run.
3
Click Open.
Canceling a listing
Generating a listing can take a substantial amount of time. If you realize that you made a mistake
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in submitting a listing request, or you do not want to wait for a listing to complete, you can
cancel it.
To cancel a listing while the listing is processing:
1
At the bottom of the Listings page, click Cancel.
2
Confirm the cancellation in the cancellation message box.
The InForm application displays a window prompting you to download or delete the listing
3
Do either of the following:
•
To download the listing to a Microsoft Excel Comma Separated Values (CSV)
file:
Click Download.
The InForm application displays a message box prompting you to save the extracted
data file on your local computer or specify that you want to open it without saving it.
Note: If you do not have Microsoft Excel on your computer, do not open the file
(do not click Open).
In this message box, click Save, and in the dialog box that appears, specify where you
want it saved.
•
To delete the listing:
Click Delete.
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Deleting a listing
If you start a listing and then move away from the Listings page or close the browser window
before it completes, or if the listing does not complete before the session times out, the InForm
application continues to process the listing on the server. The next time you click the Listings
button, the listing that was in process is available for resolution. If the listing has completed, you
can download or delete it.
Deleting a completed listing
When you log back on to the InForm application after leaving a listing in process, or when a
listing completes during your InForm application session, a window appears prompting you to
download or delete the listing.
To delete a completed listing:
•
At the bottom of the page, click Delete. You must delete a completed listing before you can
generate a new one.
Deleting a saved listing specification
To delete a saved listing specification:
1
In the Navigation pane, click Listings.
2
Open the listing specification you want to delete. For more information, see Opening a
saved listing specification (on page 240).
3
Click Delete.
A prompt box opens, containing the name of the listing specification.
4
Click OK.
Note: If you know the name of the listing specification you want to delete, skip step 2,
and type the name of the listing specification in the prompt box.
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Navigating from a listing to the source form
To navigate from a data cell in a generated listing spreadsheet to the corresponding data item in a
form:
1
Generate a listing (see "Creating a new listing " on page 237) with the HTTP Links option
2
Open the generated CSV file in Microsoft Excel.
3
Click the cell displaying the data in the spreadsheet.
4
In the browser window that appears, log on to the InForm application.
selected.
The InForm application opens, and the form containing the data item appears.
Customizing a listing
To further customize the listing in Microsoft Excel:
InForm 4.6 SP3
1
From the Data menu choose Filter/AutoFilter. A drop-down list appears in the column
heading
2
Open the drop-down list and select a predefined filter, or choose Custom.
3
If you choose Custom, a dialog box opens in which you can specify a custom filter parameter
through which to view the data.
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What to do if...
You cannot download a listing
Before you can generate listings, an administrator must configure the computer on which you are
running the InForm application through a browser for listing generation.
Note: You must have Microsoft Excel spreadsheet software installed on your computer to
view data listing files.
Your session times out before a listing completes
If your session times out before a listing completes, the InForm application continues to process
the listing on the server. The next time you click Listings, you see a message indicating the status
of the listing you started. When you click OK in the message window, you can:
244
•
Cancel an incomplete listing or wait for it to complete.
•
Download or delete a completed listing.
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CHAPTER 19
Using study documentation
In this chapter
Overview: Using study documentation........................................................................................... 246
Viewing study documentation .......................................................................................................... 247
Displaying help for a form ................................................................................................................ 248
Working with FAQs........................................................................................................................... 250
What to do if... .................................................................................................................................... 255
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Overview: Using study documentation
Online study documentation is an optional feature of the InForm application. Depending on the
way your trial is set up, you can have access to one or more of the following types of study
documentation:
•
Protocol—A copy of the sponsor’s trial protocol, formatted for online viewing.
•
CRF help—A set of instructions and other details about specific CRF data items or about
an entire CRF. CRF help can also include:
•
Information about the edit checks on CRF items.
•
Frequently Asked Questions (FAQs), which provide answers to questions about CRF
items. FAQs are responses to questions and issues that come up when users enter data
in CRFs. Based on the experiences of users who are entering data, a FAQ can clarify
instructions, provide additional details, or point users to resources that might be useful.
FAQs are associated with specific data items on CRFs. Users with rights to maintain
FAQs can add or update them in response to questions that come up during the course
of a trial.
•
Visit calculator—A copy of the Visit Calculator page that appears at the end of the
enrollment process. The Visit Calculator page computes suggested visit dates based on the
date of the enrollment visit. You can edit the start date to determine suggested visit dates
that conform to the visit timing specified in the study protocol.
•
Sample trial case book—A complete set of read-only blank CRFs that you can use to
familiarize yourself with the layout of the forms and visits.
As well as giving access to study documentation through the document window, the InForm
application enables you to link directly to CRF help on a CRF or CRF item, if your trial is set up
to provide those links. If these links are set up, the CRF name and the item descriptions in a
CRF are underlined. As you pass the mouse cursor over a link, the cursor changes to a
pointing-hand icon.
To display the CRF help for a CRF or CRF item:
•
246
Click the underlined CRF name or item text.
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Viewing study documentation
To view study documentation:
1
In the Navigation pane, click Documents.
2
Click the tab indicating the type of document you want to display.
If you selected the Protocol or CRF Help tab, the left pane of the Documents window
contains a table of contents that applies to the displayed document.
3
InForm 4.6 SP3
To navigate to a specific topic within the document, click the appropriate link in the table of
contents.
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Displaying help for a form
If your trial is set up to support this method, you can navigate from a form to the applicable part
of CRF help:
Note: If your trial supports this type of navigation to form help, the text of the CRF name and
item descriptions are underlined.
248
1
In the Navigation pane of the InForm window, click Patients.
2
In the Case Books List, click the traffic light icon for the patient and visit.
3
Click the tab for the form.
4
Do one of the following:
•
To view form help on the entire form—At the top of the page, click the underlined
form name.
•
To view form help on a specific form item—Click the underlined item description.
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Working with FAQs
FAQs are responses to questions and issues that arise when users enter data in CRFs. Based on
the experience of users who are entering data, a FAQ can clarify instructions, provide additional
details, or point users to resources that might be useful. This section describes how a user who
has rights to maintain FAQs can add or edit a FAQ.
Adding a FAQ
1
In the Navigation pane, click Documents.
The document window opens.
2
Click the CRF Help tab.
The left pane displays the table of contents for form help, with links to the help topics for
specific forms.
3
250
Use the Table of Contents to locate the topic for the form, and click on the underlined text
to display the topic.
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4
In the document window, click Add/Edit FAQ.
The document text pane splits in half. The top half displays the text of the form help,
broken down by items. Each item is labeled. The bottom half displays the FAQ Entry form.
5
In the Item list on the FAQ Entry form, select the item for which to add a FAQ.
6
In the FAQ box, enter the text of the FAQ.
7
Click Submit FAQ.
The InForm application adds a FAQ to the form help for the item, along with an audit trail
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indicating the date and time it was added and the user who created it.
Editing a FAQ
1
In the Navigation pane, click Documents.
The document window opens.
2
252
Click the CRF Help tab.
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The left pane displays the table of contents for form help, with links to the help topics for
specific forms.
3
Use the Table of Contents to locate the topic for the form, and click on the underlined text
to display the topic.
4
In the document window, click Add/Edit FAQ.
The document text pane splits in half. The top half displays the text of the form help,
broken down by items. Each item is labeled. The bottom half displays the FAQ Entry form.
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5
In the Item list on the FAQ Entry form, select the item for which to edit a FAQ.
6
Click Edit FAQ.
The InForm application displays the current text of the FAQ.
254
7
In the FAQ box, edit the text of the FAQ.
8
Click Submit FAQ.
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What to do if...
Certain forms or items always cause confusion
If certain forms or items are particularly confusing, or generate many queries, ask your trial
administrator to do one or both of the following:
InForm 4.6 SP3
•
Create additional form help for the forms or items.
•
Create a FAQ that covers the forms or items.
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256
InForm 4.6 SP3
CHAPTER 20
Using InForm online help
In this chapter
Displaying online help ....................................................................................................................... 258
Navigating InForm online help ........................................................................................................ 259
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Chapter 20 Using InForm online help
Displaying online help
Online help appears in a separate browser window from the study.
To open the online help window:
•
258
In the Navigation pane, click Help.
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Navigating InForm online help
Within the online help window, you can find topics of interest and display them from several
points of reference.
Using the Table of Contents
The Table of Contents is an expanding and collapsing hierarchical list of all of the topics in the
online help system. When you open the online help window, the Table of Contents is visible.
To display any topic:
•
In the Table of Contents, click the name of the topic.
The topic appears in the right pane of the online help window, and a box appears around its
name in the Table of Contents to mark your place.
To expand a book and display its related topics:
•
Click the plus icon.
To collapse a group of topics and display only the book topic:
•
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Click the minus icon.
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Chapter 20 Using InForm online help
To display the Table of Contents when the Index page is visible:
•
Click the Contents tab at the top of either the left or the right pane of the online help
window.
Using the Index
The Index is an alphabetical listing of keywords that refer to topics in the online help.
260
To
Click the
Jump to the topics for a particular letter
of the alphabet.
Letter in the alphabet box at the top of the Index page.
Jump to a topic listed in the Index.
Topic name.
Display the Index when the Table of
Contents is visible.
Contents tab at the top of either the left or the right
pane of the online help window.
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Using the Search tool
The Search tool enables you to find topics based on search text that you enter. To use the Search
tool:
1
Click Search at the top of the help window.
2
Type a keyword or phrase in the text box.
3
Press Enter.
The help window displays the results of the search. If the keyword or phrase appears in a topic
title, the window displays the title. If the keyword or phrase appears in the text of a topic, the
window displays the topic title and the text containing the keyword or phrase. To display a topic
in the search results list, click the underlined text.
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Using other links
In addition to the Table of Contents and Index, you can use links within topics to navigate the
online help system.
In-topic navigation buttons
A set of navigation buttons appears at the top of each topic. You can use these buttons to move
through the online help system.
In This Chapter lists
Each book topic includes a list of related topics. To display one of these topics, click its name in
the In This Chapter list.
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Links within topics
Some topics contain links to other topics. These links appear as underlined text. To display the
topic referred to by the link, click the underlined text.
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CHAPTER 21
Synchronizing a trial
In this chapter
Overview: Synchronizing a trial ....................................................................................................... 266
Data conflict messages on comments ............................................................................................. 267
What is synchronizing? ...................................................................................................................... 270
Before you can synchronize.............................................................................................................. 271
Ways to synchronize .......................................................................................................................... 272
About conflicts ................................................................................................................................... 273
Synchronizing a trial manually .......................................................................................................... 275
Using the Sync Message Exchange tool.......................................................................................... 276
Ways to synchronize manually ......................................................................................................... 279
Synchronizing from within InForm Unplugged............................................................................ 280
Transferring data as files ................................................................................................................... 281
Viewing synchronization status information ................................................................................. 284
Viewing connection status details .................................................................................................... 285
Resolving conflicts ............................................................................................................................. 289
What to do if... .................................................................................................................................... 301
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Overview: Synchronizing a trial
The InForm Unplugged module of the InForm application enables users in different locations to
work on copies of a trial that run on separate computers. By using this version of the InForm
application, users can carry a trial database and the InForm application on a laptop or other
mobile computer and work without being connected through a browser to a central database.
Of course, if multiple users are updating different copies of the InForm database, those
databases become more and more out of sync over time. The synchronization service of the
InForm Unplugged software keeps the copies of the InForm database synchronized by copying
new and changed data across specific connections between the different computers that are
running the trial. This chapter describes several ways to exchange data between copies of a trial
that run independently on multiple computers.
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Data conflict messages on comments
Like patient data values, comments can be in conflict when users who are working on the same
patient with different copies of the trial attempt to synchronize the trial. If configured to issue
data conflict messages, the InForm Unplugged software issues a data conflict message when
comments are in conflict. The item or form that gets the data conflict message depends on the
comment:
•
If the conflict occurs on a data item, the InForm Unplugged software generates the data
conflict message on the data item.
In this example, both BJ Smith and ME Miller entered comments documenting the fact that
the results of the test could not be obtained.
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•
If the conflict occurs on a form-level comment, the InForm Unplugged software generates
the data conflict message on the first item on the CRF.
In this example, BJ Smith and ME Miller each entered a form-level comment documenting
the fact that the physical examination covered by the PE form was conducted a few days
later than the date called for in the protocol. The data conflict message generated by these
actions appears on the first item of the form.
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•
If a form-level comment on two computers documents a reason why the form is incomplete,
the InForm Unplugged software shows the data with the latest date time stamp on the form
and generates a data conflict message on each item.
In this example, ME Miller and BJ Smith both entered a form-level comment on the CGI
form before synchronizing. The CGI form reflects the later entry and comment text. Each
item on the form receives a data conflict message on the comment. In addition, because the
reasons that the form was incomplete differed, the data values shown on the form are
different for each user (one form indicates Not Done, the other form indicates Not
Applicable). Therefore, the InForm Unplugged software issued data conflict messages on
the data values as well as on the comments.
To resolve data conflict messages on comments, use the same process that you would use to
resolve a data conflict message on a data item:
•
Consult to agree on the appropriate comment text.
•
Answer the data conflict message.
•
If the appropriate comment text is other than the latest value displayed in the Comments
page, update the comment text appropriately.
For more information, see Answering queries (on page 133) and Updating form data (on
page 115).
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What is synchronizing?
Synchronizing is a mechanism that is used to create identical copies of a trial on multiple
computers. It is the process of copying trial definition and patient data from a source computer
to a destination computer along a predefined connection.
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Before you can synchronize
Before you can synchronize data between two computers in your system, the following
prerequisites must be satisfied:
InForm 4.6 SP3
•
The InForm Unplugged software must be installed on both computers.
•
An administrator must set up a connection definition between the computers.
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Ways to synchronize
The InForm Unplugged software module enables you to synchronize automatically, on a
schedule specified in a connection definition, or manually. When you allow synchronization to
occur automatically on the defined schedule, data is transferred in one direction—from the
source computer to the destination. If the connection definitions on both computers have the
same schedules, synchronization occurs in both directions at nearly the same time, in two,
opposite, one-way synchronization actions.
However, if you synchronize manually by using the Synchronize New Data button in the Admin
feature of the InForm Unplugged software, the source computer sends a message to the
destination computer to tell it to synchronize back. Therefore, in this manual synchronization
mode, two-way synchronization occurs on the initiation of the user at the source computer. The
Sync Message Exchange tool, which enables mobile computer users to synchronize to a central
computer with a static IP address, also performs a two-way synchronization. A third way to
synchronize is to transfer new data to a set of files and email the files to the person using the
computer you want to synchronize with.
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About conflicts
Conflict resolution is the process that the InForm Unplugged software uses to handle the
possibility that multiple users might have updated the same object, potentially with different data
values, between synchronizations.
How a conflict could occur
Consider the following scenario:
•
A CRA on the road enters the text of a query, inadvertently making a typographical error.
Arriving at the next site, the CRA performs a synchronization with the home computer.
•
Back at the home office, a CDM reviews the query text, notices the typo, and corrects it.
•
That night in the hotel room, the CRA reviews the previous day’s work, notices the same
typo, also corrects it, and adds an additional note.
•
The CRA performs another synchronization with the home computer, and a conflict
situation exists. The CRA and CDM have updated the same data before synchronization,
and the InForm Unplugged software must resolve the conflict.
Note: When performing conflict resolution, the InForm Unplugged software determines which
version is current without regard to the actual value of the data that was changed. Thus, even
if the value of the data is the same in both versions, performing a synchronization results in
choosing one of the versions as the current version.
How the InForm Unplugged software handles conflicts
The InForm Unplugged software uses a set of rules to determine how to handle the
synchronization of objects that have been updated on both the source and destination
computers in a synchronization connection.
•
The first rule that applies in all situations is that data entered on any computer in the
synchronization topology is never discarded, and the InForm Unplugged software maintains
an audit trail of all data entries and updates.
•
The second rule is that the latest data value entered on any computer is considered the
current value after synchronization.
When a conflict exists, the InForm Unplugged software highlights the fact and depends on users
to communicate with each other, identify the true current value, and update the CRFs in the
appropriate manner. The software uses the following methods to highlight the existence of a
conflict:
InForm 4.6 SP3
•
If two users update the same patient data item or comment on two different copies of the
trial, the InForm Unplugged software issues a data conflict message in the form of a query, if
the trial is configured to do so.
•
If two users change the state of the same query in different ways, the InForm Unplugged
software identifies a query conflict if it cannot automatically resolve the state.
•
If two users change the text of the same query in different ways, the InForm Unplugged
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Chapter 21 Synchronizing a trial
software identifies a query conflict.
•
If two users update the same patient data item on two different versions of the same form (if
a form has been revised and the revision has not been synchronized before the data entry
occurs), the software creates a conflict visit and form.
When conflicts occur, the users whose data updates are in conflict must resolve the conflicts
manually. For more information, see Resolving conflicts.
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Synchronizing a trial manually
For the most part, synchronization happens automatically on the schedules that administrators
define. However, there might be times when it is advantageous to synchronize without waiting
for the next automatic synchronization. In these cases, you can override the schedule defined in
your computer’s synchronization connections by starting a synchronization manually. If a
connection is defined with no schedule, manual synchronization is the only way that
synchronization can occur.
Note: It is anticipated that most CRCs will run the InForm application through a browser
connected to a server on which synchronization occurs automatically on schedule. CRAs who
travel between sites might find it advantageous to work offline and synchronize manually when
an internet connection is available.
Reasons to synchronize manually
Examples of reasons to synchronize manually:
InForm 4.6 SP3
•
A trial developer has created a new version of a CRF to reflect a change in the trial protocol.
•
You are a CDM and you just froze a case book.
•
You are a PI and you signed several CRFs.
•
You travel with a mobile computer that has no defined synchronization schedule.
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Using the Sync Message Exchange tool
The Sync Message Exchange tool enables users to update all synchronization connections from a
dialup, wireless, or other internet connection that uses a dynamic IP address, without being
connected to a specific trial instance through a browser. This is particularly useful for mobile
computer users who might not have an open connection to the network.
Before you can use the Sync Message Exchange tool
Before you can use the Sync Message Exchange tool, an administrator must log on to the
primary computer and define a connection to the mobile computer. This process is described in
the InForm Unplugged Administrator’s Training Companion.
Additionally, on the mobile computer, an administrator should set up the options that determine
how the Sync Message Exchange tool appears and behaves to users.
Synchronizing with the Sync Message Exchange tool
Using the Sync Message Exchange tool
To use the Sync Message Exchange tool:
1
Select Start > Programs > Phase Forward > InForm 4.6 > InForm Sync Exchange.
The Sync Message Exchange dialog box appears on your desktop, if it is set up to do so, and
a traffic light icon appears in the system tray at the lower-right corner of your screen.
2
276
Select the name of the trial running on your computer. Alternatively, if you have more than
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one trial running on your computer, and you want to synchronize all trials at once, select
ALL.
3
Select Synchronize New Data.
The connection is automatically established and data is exchanged between the two
computers. First, the data is pulled from the computer at the other end of the connection to
the mobile computer. Next, the data is pushed from the mobile computer to the destination
computer. The status bar in the Sync Message Exchange dialog box shows each step in the
synchronization. At each stage of the synchronization, the colors of the traffic lights (in the
icon that is located in the lower right corner of your screen) reflect the following changes in
status:
Traffic light colors
Indicate this status
Flashing yellow and green
Connecting, preparing, or synchronizing
Green
Complete
Red
Error
Note: If your trial has a connection to more than one other computer, the Sync Message
Exchange tool performs a synchronization on each connection. If you are working on
more than one trial on your computer, and you elect to synchronize all trials at once by
selecting All in the Source Trial list, the Sync Message Exchange synchronizes each trial
in turn, and a trial status bar appears in the window to indicate which trial the tool is
working on.
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Hiding the Sync Message Exchange tool
For your convenience, you can hide the Sync Message Exchange dialog box while the tool is
working.
To hide the Sync Message Exchange tool:
•
Click Hide.
Note: An administrator of your computer can make this hidden mode the default.
To make the Sync Message Exchange tool visible:
•
278
In the lower-right corner of your screen, right-click the traffic light icon, and select Show
Detail Window.
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Ways to synchronize manually
The InForm Unplugged module provides the following ways to synchronize manually:
InForm 4.6 SP3
•
Use the Sync Message Exchange tool. This tool is a separate utility that runs on your
computer desktop and enables you to synchronize if you can connect to another computer
by using a dialup, wireless, or other internet connection. If you are a mobile computer user,
this method is recommended.
•
Use the Synchronize New Data button within the InForm Unplugged software. This
method is useful if you are running the InForm application on a network computer and you
have performed a critical update activity that should be synchronized throughout the system
as soon as possible.
•
Use the file transfer utility to copy new data to media that can be mailed to another user
for uploading. This method provides a backup form of transport if no other methods of
synchronizing are practical or available.
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Synchronizing from within InForm Unplugged
To synchronize a trial:
1
In the Navigation pane, click Admin.
2
Click Synchronization.
The Synchronization Connections page appears.
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3
Find the name of the server with which you want to synchronize and click the checkbox to
the left of that row.
4
Click Synchronize New Data. On the computer where you are initiating the synchronization,
the InForm Unplugged software collects any data that has been added or updated since the
last synchronization, puts it into a queue, and copies it to the server to which you are
connected. The destination computer performs the same actions in reverse with data that
has been added or updated since the last synchronization.
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Transferring data as files
A specialized form of manual synchronization uses the file transfer utility of the InForm
Unplugged software. This utility gives anyone using a computer without access to a dial-up
connection or a LAN a method of transferring data via files. During file transfer, you can copy
data to be synchronized:
•
From the trial running on your computer to a removable medium such as floppy disks, a Zip
drive, a CD-ROM, a tape, or an external SCSI drive. After transferring the trial data, you can
send the disks by mail or delivery service to the user of the destination computer.
Alternatively, if you have a lot of data to send, you can store the trial data on a directory on
your computer and then copy them manually to the removable storage medium.
•
From media received from another user to the trial on your computer.
Before you can transfer by file
Before you can use the file transfer utility, an administrator must set up a connection on your
computer. This connection identifies the computer with which you will be synchronizing and
indicates that data will be transferred by file.
Transferring data to or from the trial
You can use the file transfer utility to copy data from the trial on your computer to a file or to
copy data from a file to the trial.
To download patient data to a file
1
In the Navigation pane, click Admin.
2
Click the Synchronization tab.
The Synchronization Connections page appears.
InForm 4.6 SP3
3
Select the checkbox for the File type connection you want to synchronize. You can identify
this connection by the name of the computer displayed in the Machine Name column.
4
In the Connection Type column, select the File link.
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The File Transfer page appears.
5
In the File Transfer Media text box, enter the drive and directory path where you want the trial
data copied. This can be an external drive (for example, A:\) or a hard drive on your
computer.
If you are copying to the floppy drive, make sure the first disk is in the disk drive and ready
to receive data.
6
Click Download.
The status field appears and tells you the progress of the download.
If the data you are exchanging does not fit on one floppy disk, the InForm Unplugged
software prompts you to insert additional disks.
Note: If you are using floppy disks, make sure you number the floppy disks as the
InForm Unplugged software copies data to them. The user who receives them must
load the disks onto the destination computer in the same order in which the data is
copied from the source computer.
To copy patient data from a file to your trial database
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1
In the Navigation pane, click Admin.
2
Click the Synchronization tab.
3
In the Connection Type column, select File for the connection you want to synchronize. You
can identify this connection by the name of the computer displayed in the Machine Name
column.
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Step by Step for CRCs and CRAs
The File Transfer window appears.
4
In the File Transfer Media text box, enter the drive where the files you want to copy to your
trial are stored. This could be an external driver (for example, A:\) or a network drive to
which you have access.
5
Make sure the first disk or other media is in the specified drive.
6
Click Upload.
The status field appears and tells you the progress of the upload.
If the data you are exchanging is on more than one floppy disk, the InForm Unplugged
software prompts you to insert additional disks.
Note: The floppy disks must be inserted in the same order in which data was copied to
them by the source computer. If the floppy disks are inserted in the wrong order, the
synchronization process stops and resumes only when the missing information arrives.
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Viewing synchronization status information
You can see a summary of each specific connection state on the Synchronization Connections
window, including:
•
Name of the computer with which the connection is established.
•
Type of connection (HTTP or file).
•
Date and time of the last synchronization.
•
Date and time of the next scheduled synchronization.
•
Connection state (enabled or disabled).
•
Status of the last synchronization:
•
Initializing
•
Processing
•
New Data
•
Error
•
Complete
Additionally, for each connection definition, you can view a synchronization status log.
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Viewing connection status details
The synchronization log screens enable you to view connection status history at a summary and
detailed level. You can use these screens to:
•
Resend data that has not been received in a synchronization.
•
Display and capture information about the synchronization transmission for the help desk.
Viewing the log summary
To view the log summary:
1
Click Admin and then the Synchronization tab.
The Synchronization Connections page appears.
2
In the Log column for the connection you want to examine, click Details.
The Log Summary page appears, showing how many messages have been:
•
Queued for processing at the source computer.
•
Sent through the connection.
•
Received at the destination computer.
•
Confirmed as processed by the destination computer.
This log is cumulative over all transmissions.
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Viewing synchronization log details
For additional details about transmitted messages:
1
Click Admin and then the Synchronization tab.
The Synchronization Connections page appears.
2
In the Log column for the connection you want to examine, click Details.
3
Click Log Detail.
The log detail page appears and displays status information about each message. For each
message, you can see:
•
Transaction type—Incoming or outgoing at the local computer.
•
Status
•
Date and time that the message was sent from the source computer.
Note: If you have the Synchronize All/Re-Send Message right, you can resend all or selected
messages from the log detail page. For more information, see If you have problems during
data exchange (see "You have problems during data exchange" on page 301).
Viewing details about a specific transaction batch
To view details about a specific transaction batch:
1
Click Admin and then the Synchronization tab.
The Synchronization Connections page appears.
2
In the Log column for the connection you want to examine, click Details.
3
Click Log Detail.
4
On the Log Detail page, click an underlined message.
The Log page appears and provides the following information:
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•
Source and destination computer and the InForm server names.
•
Synchronization date and time.
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•
Number of transactions in the transaction batch.
Additionally, if the transaction batch failed to synchronize and generated a message in the
Microsoft Windows Event Viewer, the text of that message appears on the Log page.
Viewing the XML listing of a transaction batch
The Log page provides access to a view of the actual XML of the selected message, for the
purpose of debugging a failed transmission.
To display the XML details:
1
Click Admin and then the Synchronization tab.
The Synchronization Connections page appears.
InForm 4.6 SP3
2
In the Log column for the connection you want to examine, click Details.
3
Click Log Detail.
4
Click an underlined message on the log detail page.
5
Click View XML.
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A new browser window opens and displays the text of the XML transmitted in the selected
transaction batch.
6
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If you are instructed to do so by help desk personnel, save this text on your local computer
as a file with the extension HTM, and email it as an attachment to your help desk contact.
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Resolving conflicts
This section describes how to deal with conflicts that arise when any of the following situations
occur with two users who are working on different copies of a trial:
•
The users update the same data item before synchronizing.
•
The users change the state of the same query in different ways.
•
The users change the text of the same query in different ways.
•
One trial has a newer version of a form than the other, and the two users update data on the
same form before the form change is synchronized.
Resolving conflicting patient data
If your trial is configured to issue queries when data conflicts arise, the InForm Unplugged
software opens a query if two users working with different copies of the trial update the same
patient data item or comment before the trial copies are synchronized.
The queries alert you that a conflict exists; they do not automatically resolve the conflict. If the
InForm Unplugged software issues a query on conflicting patient data, do the following:
1
Contact the other user who updated the same data item.
2
Determine the correct value.
3
Update the data value if necessary.
4
Answer the data conflict message.
Note: The InForm Unplugged software initially creates the data conflict message on the
computer where the data was first changed. Then it copies the data conflict message across the
synchronization connection. Depending on synchronization timing, the copies of the data
conflict message might not appear until the following synchronization.
Queries on data items
The following example illustrates a situation that results in a data conflict message on a patient
data item.
InForm 4.6 SP3
1
A user named BJ Smith starts patient LIL on the DOV form of the Baseline visit. BJ Smith
is running the trial on a computer called Boston AC Unit and has a connection to the
Waltham AC Unit computer.
2
Before BJ Smith has a chance to synchronize to the trial that is running on the Waltham AC
Unit computer, a user named ME Miller starts the same patient by entering data in the DOV
form of the Baseline visit.
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When the two computers synchronize:
290
•
The InForm Unplugged software sets the date to the value ME Miller entered, since it is the
date and time of entry is later than the date and time BJ Smith entered the data.
•
The Audit trail shows both updates.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
•
The InForm Unplugged software issues a data conflict message against the data item.
As a result of the data conflict, the following things should happen:
•
ME Miller and BJ Smith consult to see which value is the appropriate value.
•
One of them answers the data conflict message.
•
If the correct data value differs from the latest data value that is displayed in the audit trail,
the user updates the data item to reflect the correct value.
For more information, see Answering queries (on page 133) and Updating form data (on
page 115).
Resolving query conflicts
The previous section describes data conflict messages issued by the InForm Unplugged software
in response to data entry and data update actions taken by users on different copies of a trial.
Similar conflicts can occur during data review and correction if more than one user opens,
answers, reissues, closes, or deletes the same query before synchronizing different copies of a
trial.
As with data entry and data update conflicts, query conflicts require manual resolution by users
who have the right to resolve them.
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How query conflicts can occur
Query conflicts can occur if users working on two different copies of a trial change either of the
following before the first user’s change is synchronized to the other user’s computer:
•
The text of a query.
•
The state of a query.
Query text conflicts
Query text conflicts arise when two users on different copies of a trial do any of the following
and choose different query text:
•
Open the same Candidate query.
•
Answer the same Opened query.
•
Reissue the same Answered query.
Query state conflicts
Under normal circumstances, as a query progresses from the time it is first issued until it is
resolved, the status of the query changes.
•
When a query first issued, it can be in Candidate or Opened state. A Candidate query can be
opened or deleted.
•
After a query is placed in Opened state, it must be answered.
•
An Answered query can be reissued or closed.
•
A reissued query can be in Candidate or Opened state.
Any time a user performs an action that changes the state of a query, the opportunity for a
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conflict arises if another user working on a different copy of the trial works with the same query.
A conflict occurs if both users change the query to different states—for example, if one user
changes a Candidate query to Opened and the other deletes it.
When a query conflict occurs, the InForm application updates the Query Listing page to show
the query in a conflict state.
Additionally, the Queries page for the specific query shows both versions of the query so that a
user with the authority to resolve the conflict can do so.
Before a query with a conflict can progress to the next step in resolution, the conflict must be
resolved. In this case, before a site user can answer the query, a sponsor with the right to resolve
queries must decide which version of the query to use.
Site and sponsor conflicts
Query conflicts can be either site or sponsor conflicts. This is important because only a site user
can resolve a site conflict, and only a sponsor user can resolve a sponsor conflict.
•
InForm 4.6 SP3
Site conflicts occur when two users on different copies of a trial answer the same query and
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select or type different query text.
The following example illustrates a site conflict: users ME Miller and BJ Smith have both
answered the same query but have used different query answer text.
•
294
Sponsor conflicts occur when two users on different copies of a trial do any of the
following to the same query:
•
Reissue the query in different states.
•
Open the query with different query text.
•
Reissue the query with different query text.
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Step by Step for CRCs and CRAs
The following example illustrates a sponsor conflict: users Tom Allen and Susan Merkel
have taken different actions on the same answered query: Tom Allen has reissued it in the
candidate state, and Susan Merkel has closed it.
Resolving a query conflict
The procedure for resolving either site or sponsor query conflicts is the same:
1
Log on to the InForm application as a user who has the right to resolve a query conflict.
2
In the Navigation pane, click Queries.
The Query Listing appears. When a query must be resolved, the listing includes the label
SiteConflict or SponsorConflict in the Status column.
Note: To resolve a query that has the label SiteConflict, you must be a site user. To
resolve a query that has the label SponsorConflict, you must be a sponsor user.
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3
Click the underlined form name for the query you want to resolve.
The Queries page appears. The two conflicting entries are highlighted with red text and a
pink background.
296
4
Consult the users who entered the conflicting information to determine which version of the
query is the correct one.
5
In the farthest left column, click the radio button for the query version you want.
6
In the Reason item, select or enter the text of the conflict resolution explanation.
7
Click Submit.
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The InForm application updates the query history to show the resolution date, time, user,
and reason, along with the server where the correct version was entered.
Additionally, the Status column in the Queries Listing indicates the resolved state of the
query.
Resolving study version conflicts
Recall that the InForm application handles the possibility that multiple versions of the same
form can exist in the same copy of a trial. Once a form for a patient is started, the patient keeps
that form version even if the form changes midway through a trial. When the new version of the
form is added to the trial, patients for whom that form’s data has not been collected get the new
version of the form. The same rule applies in a synchronization environment.
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How a study version conflict can occur
When synchronization enters the picture, it is possible for the same patient to be started on
different versions of a CRF. For example:
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1
BJ Smith, a CRC working remotely, enters data for patient LIL in the Clinical Global
Impression (CGI) form.
2
Meanwhile, in the home office, the CGI form is updated to capture an additional data item.
3
ME Miller, a CRC connected to the home office computer, starts patient LIL on the new
CGI form.
4
The traveling CRC synchronizes to the home office.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The versions of the CGI form are in conflict. There is no way to know whether the data
entered on the old version of the form is appropriate to the new version. If the
synchronization accepts the data associated with the latest version of the form as current,
valid data entered in the earlier version could be lost.
The InForm Unplugged software resolves this situation by:
InForm 4.6 SP3
•
Updating both copies of the trial with the most recent version of the CRF, along with the
data entered on it.
•
Creating a special visit and form in both copies of the trial to hold the data entered in the old
version. This visit is called Conflict; it appears on the timeline above the CRF, in the Time
and Events Schedule, and in the Case Books List.
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Working with the Conflict visit
The Conflict visit contains the original version of the updated form. In the example scenario, the
Clinical Global Impression form in the Conflict visit contains the data as it was entered by BJ
Smith.
Although the two copies of the trial have been synchronized to the most recent data entry done
by ME Miller, the InForm Unplugged software retains the original version in the Conflict visit
version of the form so the differences can be resolved.
To resolve a data entry difference that results from a study version conflict, a user with the
authority to update CRF data should:
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1
Consult the users who updated the two versions of the form to determine which values are
correct.
2
Update the form to reflect the correct values. If the correct values are the ones entered on
the new version of the form, no change is necessary.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
What to do if...
You have problems during data exchange
If you have problems during data exchange, you can check on the status of your transactions and
resend those that are having problems. View the status of individual transactions on the Log
Detail window. If any of the transactions have a status of Send Failed, you can manually resend
them.
Resending transactions
To resend transactions:
1
Open the Log Detail window for the connection with which you are exchanging data.
2
Check the boxes to the left of the transactions you want to resend.
3
Click Resend.
Resending all the transactions
To resend all the transactions:
InForm 4.6 SP3
1
Open the Log Detail window for the connection with which you are exchanging data.
2
Select Resend All Data.
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CHAPTER 22
Transferring patients
In this chapter
Overview: Patient record transfer.................................................................................................... 304
How to transfer patients.................................................................................................................... 309
Transferring one patient at a time.................................................................................................... 310
Viewing transferred patients ............................................................................................................. 315
Viewing the patient transfer audit trail ............................................................................................ 317
Viewing a patient archive .................................................................................................................. 320
Contents of a patient archive ............................................................................................................ 323
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Overview: Patient record transfer
The patient record transfer feature of InForm allows you to transfer a patient's information from
one site to another.
You can transfer patients one at a time using the InForm application user interface. You can also
transfer patients in bulk using InForm Data Import.
Use the InForm application user interface to transfer patients who meet any of the following
criteria:
•
Change permanent address before completing the study.
•
Have multiple residences throughout the course of the study.
•
Were initially assigned to the wrong sites or to an investigator who is no longer with the
study.
Use the InForm Data Import tool to transfer of patients if for any reason you need to transfer
several patients from one site to another at the same time. You might need to do a bulk-transfer
if, for instance, a site is closed down within the course of a study.
Whether you transfer patients individually, or transfer them in bulk, keep in mind that:
•
The InForm application allows you to transfer patients from one site to another only if the
study version at the destination site is the same or greater than the study version at the patient's
current site. (Note: To see what study version is in effect for a site, display its detail page,
available from the Sites tab of the InForm software Admin interface.)
•
You can transfer only patients who are fully enrolled; you cannot transfer a patient who is
screened but not enrolled or a patient who has failed enrollment.
•
You cannot use the patient record transfer feature if you are also using the site filtering
feature of the` InForm Unplugged application.
Audit history and patient record transfer archive
When you transfer a patient, the InForm application transfers all of the data of the patient that is
associated with the current site to the destination site. When you initiate the patient record
transfer, the InForm application automatically creates:
•
Patient transfer audit history—Audit trail information shows the date and time of the
transfer, the originating and destination site, the time zone of the destination site, the user
who performed the transfer, and the reason for the transfer.
•
Patient transfer archive—The InForm application creates an XML archive of the history
of the patient, up to and including the patient record transfer. You can use the patient
archive for submission to regulatory authorities or for a site audit.
Patient record transfer flow
When you transfer a patient, InForm application transfers all of the data associated with the
current site to the destination site. When you initiate the patient transfer, InForm application
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automatically creates:
•
Patient transfer audit history—Audit trail information includes such information as the
date and time of the transfer, the originating and destination site, time zone of the
destination site, and the reason for the transfer.
•
Patient transfer archive—The InForm application creates an XML archive of the history
of the patient, up to and including the patient record transfer. You can use the patient
archive should the originating site need to submit patient data to the FDA (via CRF submit).
The following table illustrates patient record transfer flow. The example follows the transfer of
patient XYZ from:
•
Site A to Site B
•
Site B to Site C
•
Site C back to site A
Site A
Site B
Site C
Step 1: Enroll patient XYZ.
Step 2: Add data for patient
XYZ.
Step 3: Initiate transfer for
patient XYZ to Site B.
Step 4: The InForm application
transfers patient XYZ to Site B.
Site B has edit access and control
The InForm application creates
over all data for Patient XYZ.
an archive that includes all
forms for the patient as well as
the audit history up to and
including the patient transfer.
Site A can no longer edit the
patient's data.
Step 5: Add more data for
patient.
Step 6: Initiate transfer for
patient XYZ to Site C.
The InForm application creates
an archive that includes all
patient data from both Site A
and Site B, up to and including
the most recent patient transfer.
Site B can no longer edit the data
of the patient.
Step 7: The InForm
application transfers patient
XYZ to Site C. Site C has edit
access and control over all data
for patient XYZ.
Step 8: Add more data for
patient.
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Chapter 22 Transferring patients
Site A
Site B
Site C
Step 9: Initiate transfer for
patient XYZ back to site A.
The InForm application
creates an archive that includes
all patient data from Site A,
Site B, and Site C, up to and
including the most recent
patient transfer. Site C can no
longer edit the data of the
patient.
Step 10: Data for patient XYZ
successfully transferred to Site
A. Site A regains edit access
and control over all data for
patient XYZ.
Patient status and record transfer
Study sponsors develop and maintain their own practices regarding patient status and
transferring patient records to another site. When you use the InForm application user interface
to transfer patients, the application displays patient status, so that sponsors can view patient
status before they execute the transfer. The application displays the following patient status
information:
•
Signature status—The number of required signatures that are missing for the patient.
•
Query status—The number of queries that are open for the patient.
•
Source verification status—The number of forms that have yet to be source-verified for
the patient. A form is counted as needing source verification if any entered items on the
form have not been source verified.
Note: While it might be good practice to ensure that all forms for a patient are signed and
source-verified, and that all queries a resolved before transferring a patient, Phase Forward
acknowledges that each study might have different processes and procedures. The InForm
application does not prevent the transfer of a patient with outstanding queries, outstanding
required signatures, or forms that are not source-verified.
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Patient number conflicts
The patient number is an identifier assigned to each patient at enrollment. If your study is
configured to require unique patient numbers at a site, the patient record transfer feature
prevents the creation of duplicate patient numbers at the destination site.
If you transfer patients using the InForm interface—When you begin transferring a patient,
the InForm application assumes no patient number conflict on the destination site and
automatically retains the current number of the patient for the transfer.
When you submit the transaction, the InForm application checks for any patient number conflict
at the destination site:
•
If no conflict is found at the destination site, the InForm application completes the transfer
and the patient retains his or her original patient number after moving to the destination site.
•
If a conflict is found at the destination site, the InForm application allows you to change the
patient number and resubmit the transaction.
If you transfer patients using the InForm Data Import tool—To transfer patients in bulk
using the InForm Data Import tool, you load a MedML file that specifies details of the patient
transfer. During the load process, the InForm application checks for patient number conflicts at
the destination site. If a conflict is found, processing stops for that patient, and the following
error message appears for the patient:
Patient number is not unique. Site for patient not changed.
Processing continues with the next patient in the file.
Note: Patient screening numbers do not change when a patient transfers to another site.
Patient initials and DOB conflicts
Study designers can configure a study to require that the combination of patient initials and date
of birth be unique within a site or throughout the study. If your study requires unique initials and
date of birth only within a site, it is possible to have patients at different sites with the same
combination of initials and date of birth.
If you transfer a patient to a site where another patient exists with the same initials and date of
birth, and your study requires unique initials and date of birth at the site, the patient transfer fails.
You must change the patient initials to make the combination unique.
Patient transfer and study version
The InForm application allows you to transfer patients to only those sites running a study
version that is the same or greater than the one run at the current site. When you transfer a
patient to a site at a different study version, the InForm application follows the same versioning
rules as when any site moves to a new study version:
InForm 4.6 SP3
•
If the study version at the destination site includes a new item on a form, the new item
appears only for patients who had not started the form in the source site.
•
If the study version at the destination includes a new form, the new form appears only for
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patients added after the new version is implemented.
If you are transferring patients using the InForm application user interface—The InForm
application filters the list of destination sites, displaying only those who meet this study version
criteria. You cannot choose a site that has an unacceptable study version.
Note: To see what study version is in effect for a site, display its detail page, available from
the Sites tab of the InForm software Admin interface.
If you are transferring several patients using the InForm Data Import tool—If the patient
transfer MedML file specifies a destination site with an unacceptable study version, processing
stops for that patient, and the following error message appears for the patient:
Error: A patient cannot be moved to a site which is using an older study version.
Site for patient not changed.
The patient transfer process continues with the next patient in the file.
Who can transfer patients?
To be able to transfer patients from one site to another, users must:
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•
Be assigned to an InForm rights group that enables the right to transfer patient records.
•
Be associated with both the originating and destination sites.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
How to transfer patients
The InForm application provides two different methods for transferring patients to new sites.
The method you use depends on whether you want to transfer a single patient, or whether you
want to transfer patient records in bulk.
•
Transferring one patient at a time by using the InForm software Admin interface. This
option is described in this document.
•
Transferring several patients at once by using the InForm Data Import tool. This option
is described in the InForm Utilities Guide and in the online help for the InForm Data Import
tool.
Note: To transfer patients by using the InForm application user interface, you must have
appropriate InForm access rights to be able to transfer patient records. In addition, you must
have access to both the originating site and the destination site.
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Transferring one patient at a time
To transfer a single patient record to a different site:
1
In the Navigation pane, click Admin.
2
Click the Sites tab.
A list of sites appears. The tab also displays the site abbreviation, the email address for the
site contact, and a Patients column.
3
310
Identify the current site for the patient you want to move. In the Patients column for that
site, click Transfer.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
A list of patients at the site appears.
4
Identify the patient you want to move and click Transfer in the Action column.
The Patient Record Transfer page appears.
5
InForm 4.6 SP3
Read and understand the information in these sections of this page:
311
Chapter 22 Transferring patients
•
Patient Record Transfer Affidavit—This section is customized for your trial. It
provides guidance on the responsibility of the administrative user regarding moving a
patient from one site to another.
•
Patient Status—This section makes you aware if any of the following are outstanding
for the patient: missing required signatures, queries that are not closed, or forms that
require source verification.
After reading these sections of the page, you can choose to continue with the patient
transfer, or to cancel. If you choose to continue, you are assuming responsibility for the
patient transfer as described in the affidavit.
6
Complete the fields in the Enter Patient Record Transfer Information section of the page, as
follows:
Field
Description
Current Site
Display only. The current site to which the patient belongs.
Destination Site
Choose a destination site from the drop-down list. The
Destination Site list includes only those sites that you have access
to and that are running study versions that are the same as or
greater than the study version at the current site.
Patient number
The patient number. This read-only field defaults to the patient
number used at the current site. If the InForm application finds
no patient number conflict at the destination site, the patient will
retain his or her patient number when the transfer is complete.
If, however, the InForm application finds a conflict after you
submit this transaction, this screen appears again, allowing you to
edit the Patient number field.
Reason for change
Indicate the reason for the patient transfer by selecting one of
these radio buttons:
•
•

Patient change of address.

Patient is a seasonal resident.

Investigator no longer with study.
Select the Other radio button. In the text box, type a
description of the reason for the transfer.
7
Click Submit, then OK to confirm the transfer.
8
The InForm application checks the study versions at the current and destination sites:
9
312
Select the top radio button and choose one of these
predefined reason for the transfer.
•
If the current site is at a lower study version than the destination site—The
InForm application prompts you to confirm the transfer by resubmitting it.
•
If the current site is at a higher study version than the destination site—You
cannot complete the transfer.
The InForm application checks to ensure there is no conflict with the patient number at the
InForm 4.6 SP3
Step by Step for CRCs and CRAs
destination site:
•
If the InForm application finds no conflict at the destination site—The transfer
completes.
•
If the InForm application finds a duplicate patient number at the destination
site—The transfer stops until you resolve the patient number conflict, as duplicate
patient numbers at a site are not permitted in patient record transfers. The Patient
Record Transfer page displays again, allowing you to edit the patient number and
resubmit the transaction.
If the current site is at a lower study version than the destination site
You can transfer a patient only to those sites running a study version that is the same as or
greater than the version run at the current site. If the destination site for a patient transfer is at a
higher study version than the current site, the InForm application displays a message prompting
you to confirm the transfer by resubmitting it.
To resubmit:
1
Click OK to clear the message.
2
Click Submit.
3
In the confirmation message, click OK.
If the current site is at a higher study version than all other sites
You can transfer a patient only to those sites running a study version that is the same as or
greater than the version run at the current site.
When you begin transferring a patient from the Patient Record Transfer page, the InForm
application displays only the sites that you have access to and that meet this study version
criteria.
If no sites participating in the study meet the study version criteria, the Patient Record Transfer
page displays a message indicating there are no acceptable sites to which to transfer the patient.
If the InForm application finds a duplicate patient number at the destination
site
After you submit the patient transfer transaction, the InForm application determines whether
there is a patient number conflict at the destination site. If a duplicate patient number exists at
the destination site, the transfer stops until you resolve the patient number conflict; duplicate
InForm 4.6 SP3
313
Chapter 22 Transferring patients
patient numbers at a site are not permitted in patient record transfers. Follow these steps to
change the patient number.
1
Complete the Patient Record Transfer page. For more information, see Transferring one
patient at a time.
If the InForm application finds a conflict, an error message appears.
2
Click OK.
The Patient Record Transfer page appears again.
Note: The Patient Number field is now editable.
3
Change the Patient Number field to a number that is not currently used at the destination site.
4
Click Submit.
The patient transfer transaction is complete.
314
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Viewing transferred patients
All users can see a list of all patients who have been moved to or from the current site.
To view patients that have been transferred:
1
In the Navigation pane, click Patients.
The Case Books List appears. If you have access to more than one site, the Site filter list
includes the sites to which you have access. The Case Books List displays only the patients
currently enrolled in the site or sites to which you have access.
Note: If you want to filter the display to show patients transferred to and from a
particular site, use the Site filter drop-down list.
2
Click Show Transferred.
The Transferred Patients page appears. It displays the patients who have been transferred to
or from the site or sites.
InForm 4.6 SP3
315
Chapter 22 Transferring patients
Note: If you filtered the Case Books List, the same filter is applied to the Transferred
Patients page. If you have access to more than one site, you can filter the data again
on the Transferred Patients page.
The following table describes the columns on the Transferred Patients page:
Field
Description
Patient
Patient number at the current site.
From site
The current, or originating site for the patient, before the patient
transfer transaction.
To site
The destination site.
If you had to change the patient number because of a conflict at the
destination site, the new patient number also appears enclosed in square
brackets.
If no patient number is appended on the end of the To site value, the
same patient number is used at both the originating site and the
destination site.
316
Date (GMT)
The date on which the patient transfer occurred. Note that this date is
expressed in Greenwich Mean Time (GMT).
Archive
A link to the archive of the case book of the patient. The archive shows
the data that was entered before the transfer.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Viewing the patient transfer audit trail
Users who are authorized to transfer patients or to manage site information can view the audit
trail that the InForm application creates when a patient is transferred.
To view the audit trail for transferred patients:
1
In the Navigation pane, click Admin.
The InForm application Admin interface appears.
2
InForm 4.6 SP3
Click the Sites tab.
317
Chapter 22 Transferring patients
A list of sites appears. The tab also displays the site abbreviation, the email address for the
site contact, and a Patients column.
318
3
Identify the site at which the patient whose audit trail you wish to see is currently enrolled
and click the link in the Patients column for that site. (Depending on your rights, the link
might be labeled Transfer or List). A list of patients at the site appears.
4
Click the audit trail icon (in the Audit Trail column) for the patient.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
The Site Audit Trail for Patient page appears.
The Site Audit Trail for Patient page displays the following information about each transfer
for the patient.
InForm 4.6 SP3
Field
Description
Patient Number
The patient number assigned to the patient at the site. The patient
number might be the same for every transfer a patient undergoes.
However, the patient number will vary, if, for instance, the patient
number had to be changed, due to a conflict at the destination
site.
Site
The site at which the patient is enrolled after the audited action is
taken.
Date
The date for the patient transfer. This date reflects the local time
and time zone of the destination site.
User
The InForm user who initiated the patient transfer transaction.
Reason
The reason, in text form, for the patient transfer.
319
Chapter 22 Transferring patients
Viewing a patient archive
When you transfer a patient to a new site, the InForm application generates an archive of the
case book of the patient at the originating site.
To view this archive:
1
Display the list of transferred patients. For more information, see Viewing transferred
patients (on page 315).
2
Click the View link for the patient whose case book you want to review.
A new browser window opens, displaying the initials and patient number of the transferred
patient, along with links to each form in the case book, organized by visit. Common forms
appear at the end of the list of links.
3
320
To display the archive of a particular form, click its link.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
An image of the form appears, along with links to whatever detailed information is available.
4
InForm 4.6 SP3
To display details about a form or item, click the link for the details you want.
321
Chapter 22 Transferring patients
5
322
To navigate to the previous location in the archive, click Back in your browser window.
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Contents of a patient archive
Each CRF page in a patient archive can contain the following data:
•
Form and item comments.
•
Signature history.
•
Item audit trail.
The CRF page includes links to the following types of detailed information:
Click this link
Link location
Association Summary
Right column of
Summary of repeating form instances
repeating form instance associated with the instance where the link
appears. From the association summary table,
you can navigate to either association audit
history or each of the individual associated
pages.
Audit Trail
Right column of item
Audit trail of data changes and query activity
for the item.
Comments
Right column of item
Audit trail of comments made on the item.
eCRF Audit Trail history
Top of form
Audit summary for the entire form showing
data changes and query activity for each item
in the form.
Form Comments
Top of form
Audit trail of comments made on the form.
Initial Entry
Right column of item
Record of the initial entry of data on the item.
This link is visible only if no activity has
occurred since the initial entry. If the item
data has changed or includes query activity,
the initial entry is included in the Audit Trail
of the item.
Repeating Pages
Right column of
Snapshot of current data values in the
repeating form instance repeating form instance.
InForm 4.6 SP3
To display the
323
Chapter 22 Transferring patients
Deleted items
Within the InForm application, items that are deleted appear crossed out. If you create an
archive for a form that contains a deleted item, the item appears with the word DELETED in
bold above it.
Repeating forms
Repeating forms are displayed individually and in summary form. The summary page shows only
the data for the first key items in a single table. The details of each form appear in following
tables. For example, for the Adverse Events section, a summarized version of the form appears
first, with a list of all the adverse events entered. The details of each instance follow the list.
324
InForm 4.6 SP3
Glossary
A
Ad Hoc Reporting
The Reporting and Analysis module, which allows
you to create, run, and save customized reports on
clinical and trial-management data.
adverse event (AE)
An undesirable symptom or occurrence that a trial
subject experiences during or after a clinical trial.
association
The many-to-many relationship that can exist
between two repeating forms.
audit trail
A complete record of changes that are made in the
trial database.
C
clinical project manager
A person who is responsible for all aspects of one
or more clinical trials or for the entire clinical plan
for a drug, device, or procedure.
clinical reporting package
An Ad Hoc Reporting package that provides
access to both clinical and trial-management data
for reporting. Clinical reporting packages are
unique for each trial.
clinical research associate (CRA)
A person who is hired by a sponsor to supervise
and monitor the progress of sites that are
participating in a trial.
Also called monitor, site monitor.
clinical research coordinator (CRC)
An assistant to the investigator at a site.
case book
Also called site coordinator, trial coordinator.
The collection of all case record forms (CRFs) for
a single trial participant. Also called a case record
book (CRB).
clinical trial
case record form (CRF)
coding dictionary
A form that is used to record clinical data about
trial participants.
A standardized collection of terms and the codes
that correspond to those terms.
clinical data
common form
The data that is entered on a CRF.
A form that occurs in multiple visits and contains
cumulative data.
clinical data manager (CDM)
A person who is responsible for preparing and
maintaining a trial database and for reviewing data.
InForm 4.6 SP3
See trial (on page 328).
content pane
The area that is located on the right side of the
InForm window that displays CRFs, summary
lists, CRF item details, and so on.
325
Glossary
content-specific pane
The bar that is located at the bottom of the page
that displays command buttons and navigation
controls, which vary depending on what is
displayed in the content pane.
control
A generic term for a form component, such as a
radio button, checkbox, or drop-down list, in
which you select or enter data.
control path
A sequence of IDs that define the physical
location of a data point in the InForm database.
CRF help
A study document that contains details about how
to complete the items on a form.
customer-defined database (CDD)
An extract of the trial database that gives sponsor
personnel access to the clinical data that is
collected before the trial is completed.
when a rule fails.
exclusion criteria
A list of admission criteria, any one of which
excludes a potential subject from participation in a
clinical trial.
execution plan
A script that is associated with an event, and that
sends an email message or writes to the Windows
event log.
expected form
A form that appears in the Time and Events
Schedule for a subject, based on current known
subject data. An expected form is a dynamic form
that has been activated, or appears within a
scheduled visit or a started unscheduled visit.
F
form
The data collection mechanism that is used in a
clinical trial to gather patient data.
D
G
design note
generic rule
A comment about a form component.
A rule that the trial developer can attach to
multiple items.
display override
H
A property of items that can be set to Editable,
Read-Only, or Hidden. Also called item blinding.
home page
dynamic form
The page that appears when you log on to an
application.
A form that is created in a trial only if certain
conditions are met.
I
E
inclusion criteria
element
A list of admission criteria that potential subjects
must meet to be eligible for participation in a trial.
An option that you can select from a drop-down
list, checkbox group, or radio group.
InForm Reporting and Analysis
event
A reporting application, developed by Cognos
Corporation, which has been customized and
integrated into the InForm software by Phase
A component that specifies the action to take
326
InForm 4.6 SP3
Step by Step for CRCs and CRAs
Forward.
Q
InForm Trial Management package
query
An Ad Hoc Reporting package that provides
access to trial management data for reporting and
allows users to share reports across trials.
A question that is automatically generated by the
InForm software or manually issued by a CRA.
Institutional Review Board (IRB)
RefName
A group that reviews biomedical research that
involves human subjects.
A name that uniquely identifies a trial component
definition.
investigator
regular form
The clinician who is responsible for treating
subjects, executing the protocol of a study at a
specific site, and filling out CRFs for subjects.
A CRF that is used to collect data that is specific
to the visit in which the form occurs.
Also called clinical investigator, investigator,
primary investigator.
repeating form
itemset
R
A form that can have multiple instances within a
visit.
A collection of repeating items on a form.
rule
M
A script that checks whether data is valid or that
sets the value of an item based on a calculation.
medical monitor
A person who designs the trial protocol and
reviews data.
N
navigation pane
The left side of the InForm window, which
displays navigation buttons that you use to enter
the functional areas of the InForm software.
P
rule dependency
An additional item that is required for rule
processing.
S
screening and enrollment
The process of adding a subject to a study.
serious adverse event
A grouping of reporting elements from one or
more data models. Two reporting packages are
installed with every InForm trial: the InForm Trial
Management package and a trial-specific clinical
reporting package.
An adverse medical occurrence that is
life-threatening, or results in death or persistent or
significant disability or incapacity; involves an
overdose or the development of cancer, a
congenital anomaly, or a birth defect; requires
inpatient hospitalization, or lengthens a hospital
stay.
protocol
signature group
The detailed plan for a clinical study.
A group of users who are authorized to sign a
specific set of CRFs.
package
InForm 4.6 SP3
327
Glossary
source verification
U
The process of comparing data that is on forms to
data on source documents, checking for
inconsistencies or errors, and recording the results
of the review.
unscheduled visit
A visit that occurs in addition to the visits
prescribed by the study protocol.
V
sponsor
visit
The individual, company, or organization that is
responsible for the initiation, management, or
financing of a clinical study.
A subject evaluation checkpoint when data is
collected.
standard report
A scheduling aid that enables you to compute and
print suggested visit dates based on the patient
start date. The visit calculator page appears when a
patient is enrolled and is also available as part of
the trial documents.
A report that is included within all Reporting and
Analysis installations.
started form
visit calculator
A CRF that is submitted or that contains data, a
query, or a comment.
started visit
A visit in which at least one non-common
expected form has been started.
SV Report
A printed version of one or more CRFs that CRAs
use to perform offline source verification.
T
trial
The systematic study of a test article (a treatment,
drug, or device) in human subjects.
trial management data
The metric and status data pertaining to a study,
which is used to report on the status of a study
relative to its completion.
trial-specific clinical model
An Ad Hoc Reporting data model that is specific
to a trial, and that contains references to subject
data that site users enter on forms.
328
InForm 4.6 SP3
Index
A
adding a FAQ • 226
affidavit for signing • 198
answering a query
concepts • 124
methods • 124
procedure • 126
archive, patient record transfer • 296
association, form • 101
audit trail • 111
audit trail icons • 19
Audit Trail page • 55
automatic query • 170
C
cancel navigation mode icon • 21
Case Book
freezing • 191
sample • 222
signatures • 196
unfreezing • 191
unlocking • 191
Case Book list • 44
changing data • 110
changing password • 8
check box • 95
clearing data • 113
closing queries
concepts • 170
procedure • 172
comment
description of • 51
entering • 99
icons • 19
queries on • 241
Comments page • 51
common CRF • 94
concepts
acting on multiple queries • 178
answering a query • 124
changing data • 110
closing queries • 170
data entry • 94
data listings • 212
data update • 110
enrolling • 84
entering data • 94
freezing and locking • 184
InForm user interface • 18
InForm 4.6 SP3
issuing a query • 158
listings • 212
marking source verified • 132
online help • 234
patient record transfer • 278
screening • 78
signatures • 196
source verification • 136
study documentation • 222
synchronizing • 240
transferring patients • 278
updating data • 110
conflict resolution
conflict visits • 274
on queries • 265
overview • 247
query conflicts • 269
query state • 266
query text • 266
rules for • 247
site conflicts • 267
sponsor conflicts • 267
study version conflicts • 271
conflict resolution queries • 263
conflict visit • 274
conflicts
patient data • 263
query • 263
types of • 263
content pane • 18
content-specific pane • 18
controls, data entry • 95
CRF
associated • 101
common • 94
cross-reference • 50
data entry controls, types of • 95
data update • 110
freezing • 186
help on items in • 222
item details • 51
items, types of • 94
itemsets • 94
linking to CRF item help • 224
printing • 208
regular • 94
signatures • 196
status icons • 23
types of • 94
CRF help
linking to • 224
329
Index
viewing • 224
CRF indexer control • 27
cross reference view • 50
D
data entry
concepts • 94
controls • 95
procedure • 97
data listings • 212
data listings, running • 213
Data Value(s) page • 56
deleting a candidate query • 164
deleting an itemset • 117
detailed view • 49
document selection pane • 25
document text pane • 25
E
editing a FAQ • 228
enrolling
concepts • 78
procedure • 85
entering data
comments • 99
concepts • 94
procedure • 97
eraser icon • 21
erasing data • 113
F
FAQ
adding • 226
definition of • 226
editing • 228
overview • 222
file transfer synchronization • 255
filters
on Required Signatures screen • 198
form help • 57
form indexer control • 27
form navigation mode • 31, 33
form types • 94
freeze icon • 20
freezing and locking
about • 184
activities prohibited by • 184
all foms in a visit • 187
Case Book • 191
CRF • 186
icons for • 185
repeating form instances • 188
while monitoring • 189
with synchronization • 192
freezing and locking icons • 20
Frequently Asked Questions. See FAQ • 222
330
G
generating listings • 213
Go controls, home page • 30
group, signature • 197
H
help topics, related • 237
help, CRF • 57, 222
help, online
concepts • 234
procedures • 235
help, reporting • 5
hidden items • 106
home page Go controls • 30
I
icons • 19, 21, 22
audit trail • 19
cancel navigation mode • 21
comment • 19
eraser • 21
form navigation • 20
freezing and locking • 20
patient navigation mode • 21
patient order • 21
query • 20
reset value • 21
signature status • 73
traffic light • 23
visit and CRF status • 23
visit navigation mode • 21
InForm
logging in to • 8
logging out of • 64
stopping • 64
issuing a query • 159
item • 94
itemset • 94
L
linking to CRF help • 224
links, navigation • 29
listings
overview • 212
running • 213
lock icon • 20
locking
Case Book • 191
CRF • 186
Log Summary screen • 259
logging in • 8
logging off • 64
logout, automatic • 9
M
manual query • 170
manual synchronization • 249
InForm 4.6 SP3
Step by Step for CRCs and CRAs
maximum inactivity period • 9
maximum usage period • 9
meaning, signatures • 196
monitoring
closing queries • 170
freezing and locking • 184
issuing queries • 158
multiple queries • 178
source verifying • 136
most recently used pages • 30
N
navigation modes • 31, 33, 36
icons • 21
navigation pane • 25
navigation shortcuts • 30
O
offline source verification • 150
one-way synchronization • 246
online help
concepts • 234
navigating in • 235
window • 64
online source verification • 137
opening a candidate query • 162
ordering patients • 36
P
page indexer control • 26
panes
content • 18
document selection • 25
document text • 25
navigation • 25
table of contents • 25
password, changing • 8
changing • 10
hint • 12
password hint • 12
patient data conflicts • 263
patient navigation icons • 21
patient navigation mode icon • 21
patient navigation modes • 31
patient order • 36
patient order icon • 20, 21
patient record transfer
archive contents • 296
audit trail • 291
overview • 278
procedure • 284
viewing transferred patients • 289
patient visit information • 51
printing
printing a CRF • 208
protocol • 222
Protocol page • 60
Protocol window • 60
InForm 4.6 SP3
pulldown list • 95
Q
queries
and item appearance • 122
answering, methods for • 124
answering, procedure • 126
automatic • 170
closing queries, overview • 170
closing queries, procedure • 172
conflict resolution • 263
conflicts on • 265
manual • 170
on comments • 241
site conflicts • 267
sponsor conflicts • 267
state conflicts • 266
text conflicts • 266
Queries page • 53
query icons • 20
Query Listing page • 59
R
radio button • 95
read-only items • 106
recent page list • 30
Reg Docs page • 74
regular CRF • 94
regular item • 94
Required Signature page • 73
resending transactions • 275
reset value icon • 21
resolving conflicts • 263
running listings • 213
S
sample Case Book • 222
Sample Case Book • 62
screening
concepts • 78
failure • 81
procedure • 80
Screening Log page • 42
Select Action list • 28
select all checkboxes icon • 22
shortcuts, navigation • 30
signature group • 197
signatures
affidavit • 198
concepts • 196
CRF and Case Book • 196
invalidation of • 197
meaning • 196
signing a CRF or Case Book • 198
viewing signature details • 204
viewing signature status • 202
signing a CRF or Case Book • 198
signing affidavit • 198
331
Index
site conflicts on queries • 267
source verification
freezing or locking while source verifying • 149
marking SV ready • 132
offline • 150
online • 137
Source Verification Listing • 69
sponsor conflicts on queries • 267
spreadsheet, downloading data to • 212
status of synchronization • 258
stopping InForm • 64
study documentation
concepts • 222
description of • 60
procedures • 223
study protocol • 222
study version conflicts • 271
summary view • 48
SV Report page • 71
Sync Message Exchange tool • 250
synchronization
comment conflicts • 241
conflict resolution • 263
conflict resolution rules • 247
conflict visit • 274
conflicts with • 247
definition of • 244
file transfer utility • 255
freezing and locking with • 192
manual • 249
methods of • 246
one-way • 246
prerequisites for • 245
query conflicts • 265
resending transactions • 275
status information about • 258
Sync Message Exchange Tool • 250
two-way • 246
synchronization log details • 260
synchronization logs • 258
T
table of contents pane • 25
text box • 95
Time and Events Schedule • 45
traffic light icons • 21, 23
transactions, resending • 275
transferring patients
archive contents • 296
audit trail • 291
overview • 278
procedure • 284
viewing transferred patients • 289
two-way synchronization • 246
U
undeleting an itemset • 117
unfreezing
332
Case Book • 191
CRF • 186
unlocking
Case Book • 191
CRF • 186
unscheduled visit • 103
updating data
concepts • 110
deleting or undeleting an itemset • 117
procedure • 113
URL of trial • 8
V
verification, source • 136
view
cross-reference • 50
detailed • 49
summary • 48
view, cross reference • 50
viewing
CRF help • 224
online help • 235
study documentation • 223
viewing • 291
viewing transferred patients • 289
visit calculator • 222
Visit Calculator • 61
visit navigation mode • 31
visit navigation mode icon • 21
Visit Report page • 72
visit status icons • 23
visit tabs • 51
visits
conflict • 274
unscheduled • 103
W
what to do if
candidate ineligible • 90
data changes after freezing or locking • 193
data entry error • 104
data not available • 105
data update results in a query • 120
disallow enrollment • 92
enrollment data missing • 88
enrollment failure override permitted • 92
enrollment not allowed with incomplete data • 89
form changes after signature • 205
form changes after source verification • 155
form N/A, unknown, not done • 106
item N/A, unknown, not done • 105
item not editable • 106
query answer opens another query • 130
query conflict • 167
query generated • 105
signature fails processing • 205
submitting results in a • 81
synchronization fails • 275
InForm 4.6 SP3
Step by Step for CRCs and CRAs
X
XML listing of a transaction batch • 261
InForm 4.6 SP3
333
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