IRBNet User`s Manual

IRBNet User`s Manual

HCA-HealthONE IRB

IRBNet User’s Guide

HCA-HealthONE IRB

IRBNet

INTRODUCTION

The HCA-HealthONE IRB is responsible for ensuring that any research study under its jurisdiction is in compliance with federal, state, and institutional regulations. All submissions must be submitted electronically to the HCA-HealthONE IRB through IRBNet. IRBNet is a hosted service that supports electronic, on-line submissions. No hard copies will be accepted. IRBNET can be accessed at the following web address:

The Web Address: www.irbnet.org

The purpose of this document is to provide guidance for submitting to the HCA-HealthONE IRB via

IRBNet. Step-by-step instructions will be given for each type of submission.

OPTIONS AVAILABLE FOR GUIDANCE

TRAINING VIDEOS: For new users, IRBNet has developed Training videos that take you through the steps of using their system. You may access the training videos by going to: www.irbnetresources.org/tresources/training.html

and entering in the following: username: hca-healthone password: training1

The

New User Registration

Instructions provides instructions for Registering with IRBNet.

The

New Project Submission

video walks through the process of submitting an Initial Submission and the

Post-Submission Advanced Topics

video walks through the process of submitting subsequent materials like Continuing Reviews, Amendments, Study Closures, etc.

TRAINING ENERGIZERS: Training Energizers are documents developed by IRBNet that provide step by step visuals of the IRBNet Login Registration Process and the IRBNet electronic submission process that help users understand how to use the system. It is recommended that you print these documents and keep them as a reference to help you navigate in IRBNet.

If you have any questions regarding submitting via IRBNet, please contact the HCA-HealthONE IRB administrative office at 303-584-2300.

Thank You!

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TABLE OF CONTENTS

1. Registration Instructions……………………………………………………..

2. Track Training Tool Instructions…………………………………………

3. Instructions for Initial Submissions (Create a New Project)

4. Continuing Review Submission Instructions………………………

5. Amendment/Modification Submission Instructions…………..

6. Study Closure Submission Instructions……………………………..

7. AE’s, Protocol Deviations and UAE’s………………………………….

8. Response to Modifications Required………………………………...

9. Incomplete Submissions…………………………………………………...

10. Other Submissions………………………………………………………

11. Frequently Asked Questions (FAQ’s)……………………………...

12. Explanation of IRBNet Terms/Glossary…………………………

13. How to Label Your Submission Types……………………………

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I. INSTRUCTIONS FOR REGISTERING WITH IRBNET

1. Go to http://www.irbnet.org

2. Click on the ‘New User Registration’ link in the upper right-hand corner of the screen

3. Create your username and password. Fill out the required information. Your password must contain 8 characters. Click ‘Continue

4. Read and Accept the Individual User Terms of Use

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5. To add your affiliation, type the word ‘HCA-HealthONE’ into the search box. Click ‘Display’.

Select ‘HCA-HealthONE LLC, Denver, CO’ from the organization box. Click ‘Continue

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6. Enter your contact information. Enter the email address you will use to receive communications through the IRBNet system. (e.g. notification of IRB decisions, communications from your research team or administrator). Click ‘Continue

7. Review the information you provided and edit as necessary. When you are satisfied, click

Register

IMPORTANT: An email will be sent to the email address you provided in Step 6, with ‘IRBNet

Activation Required’ in the subject line. If you do not receive the confirmation in a short period then check your junk folder to see if it is there. You will need to click on the link provided in this registration email in order to activate your account. Clicking on the link will take you to the

IRBNet homepage.

If you have problems activating your account or have forgotten your password, please click on the

Forgot your Password

?” text in the upper right corner of the IRBNet home page.

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NONS FOR USING THE TRACK TRAINING

TOO

INSTRUCTIONS FOR USING THE TRACK TRAINING TOOL

Step 1: Upload appropriate Training and Credential (T&C) documents to your User Profile (i.e.,

NIH or CITI Human Subjects Protection Training documents, CV’s.)

I

NSTRUCTIONS

Click on ‘Add New Record

S

Step 2: Enter the appropriate information and select the correct T&C document. Be sure to enter accurate Credit Hours and Expiration Date if applicable.

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Click ‘Attach’ to upload the document. Click ‘Browse’ to select the correct T&C document to upload.

Step 3: Submit uploaded T&C documents to the HCA-HealthONE IRB.

Click ‘ Submit ’ to submit the document to the HCA-HealthONE IRB

Step 4: Upload additional T&C documents as needed and keep your existing documents up to date as credentials change

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The highlighted expiration date indicates the document will expire within the next 60 days.

Manage each T&C document using the icons. To update a document, use the Pencil icon.

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III. INSTRUCTIONS FOR INITIAL SUBMISSIONS

To submit a study for review, you must first

CREATE A NEW PROJECT

(Study) to hold your documents. Any type of document can be uploaded, but your study MUST include all the required forms for a complete package before any action can be taken on behalf of the board. A good place to start is ‘Checklist – New Submissions’ which includes a list of the required forms for a New

Study. This and other checklists can be found under “Other Tools” (Forms and Templates) on the left side of your screen.

Please Note: If you are submitting on behalf of the Principal Investigator (PI), the PI must be registered in IRBNet so that he/she can sign your package later in the submission process.

Step 1:

Step 2:

Log In to www.irbnet.org

using your username and password (for First Time Users, you must Register with IRBNet; please see INSTRUCTIONS FOR REGISTERING

WITH IRBNET/ page 3.)

The default page will be

MY PROJECTS

, where you will have access to all of your existing studies as well as the ability to create new studies. Click

CREATE NEW

PROJECT

(on the left side of your screen).

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Fill in the relevant information about your project (title, PI name), click ‘Continue’

Step 3: You will now be on the DESIGNER page where you will download forms, templates, and reference materials to assemble a new study. Select ‘HCA-HealthONE, LLC,

Denver, CO’ from the ‘Select a Library’ drop-down menu

Then Select the necessary forms that pertain to your initial submission from the

Select a Document’ drop down menu. Save these documents to your computer in a place where you can find them again (i.e., desktop, My Documents, etc.). Click the

Browse” button and find the completed document on your hard drive. Once you find the document, click the “Attach” button to upload the document. Assemble your document package through clicking on ‘Add New Document’ until all documents have been added, and use the checklist as a reference guide.

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Label your documents appropriately using the drop down list on the ‘Attach

Document’ screen (i.e., Application Form, Consent Form, Protocol, Letter, etc).

Once you have attached a document to your study package, the Study Designer page will now list your documents.

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Step 4:

On-Line Document

Please Note: The On-Line Document provides detailed information about your study that may not be listed in the protocol or the informed consent. The On-Line Document

MUST be completed for ALL initial submissions.

Go to the ‘On-Line Document’ (IRB Registration Form) at the bottom of the

DESIGNER page and click ‘ADD’. Complete this form, then click ‘SAVE AND EXIT’.

User Tip: You do not need to complete the entire online form in one sitting; you can

‘save and exit’, and then go back and update the document by clicking the pencil icon next to the document listed in the designer. When you have completed the IRB

Registration Form, click “Preview” to see what the completed form looks like, and confirm that all the information provided is accurate.

All other required forms are to be completed, saved and attached to the submission.

SHARE THIS PROJECT

with your research team. Click the ‘Share this Project’ button on the left side of your screen; click the blue ‘Share’ link to grant access to this project.

Select ‘HCA-HealthONE. LLC Denver, CO’ from the organization box; click ‘Select

Organization’ and search for registered users with whom you’d like to share this project (i.e. your Principal Investigator, Co-Investigators, other study staff, etc.)

Grant each user a level of ACCESS:

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Please Note: To ‘Share’ your research with someone, they must be registered with irbnet.org

Step 5:

Step 6:

Selected users will be notified automatically via email that the project has been shared with them, and you may enter comments to be included within the email.

When all the necessary documents are uploaded to the package, the Principal

Investigator must sign your package electronically. Send an e-mail to the PI using the “Send Project Mail” function and request that the PI sign the package.

Click on

SIGN THIS PACKAGE

. The Principal Investigator MUST sign the package before it is submitted. Select your appropriate role from the dropdown box and click ‘Sign’.

Note: If a submission is submitted without the Principal Investigator signature, the submission will not be accepted for review.

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Step 7: Once the PI has signed the package, click

SUBMIT THIS PACKAGE

. Select “HCA-

HealthONE IRB, Denver, CO” in the “Search for Organization” drop down menu

(This will be your default location and should be highlighted already).

Then click the ‘Continue’ button. In the Submission Type drop-down menu, select ‘New

Project’ and click ‘Submit’. Once you hit the “Submit” button, you will be given a confirmation showing the time your submission occurred.

Once you hit the “Submit” button, you will be given a confirmation showing the time your submission occurred.

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Step 8: To review what has been sent, click

PROJECT OVERVIEW

. The submission will be under ‘Pending Review’ status until a decision by the board has been made. Once a decision letter is formulated, an email will be sent to everyone who has full access and the letter and any supporting documents can be printed.

User Tip: Keep in mind that once you click “Submit” your study is now locked and no

other changes can be made to this package. Take the time to be sure all documents

are attached and in the final version prior to submitting. Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections.

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IV. INSTRUCTIONS FOR SUBMITTING A CONTINUING REVIEW

THE SUBMISSION OF A CONTINUING REVIEW OF AN OPEN STUDY REQUIRES THE CREATION

OF A SUBSEQUENT PACKAGE IN A PROJECT.

Step 1:

Step 2:

Login to IRBNet; www.irbnet.org

. This will take you to the

MY PROJECTS

page.

This is where all of the studies that you have access to will be housed.

Click on the Title of the project that you would like to continue/renew (click on the exact IRBNet project referenced in the e-mail you received reminding you to renew your study). Then click on the

PROJECT HISTORY

Step 3: Click on

CREATE NEW PACKAGE

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Step 4: A

NEW DOCUMENT PACKAGE

will appear as a “Work in Progress”. Click on the

New Document Package

title and you will be brought to the

DESIGNER

screen where you can add your documents for this package.

Step 5: You will now be on the

DESIGNER

page.

This is where you can access the library of forms as well as any documents from previous packages you have submitted.

From the HCA-HealthONE IRB Library (Step 1 – top of screen), Select and download both ‘Checklist – Continuing Reviews’ and ‘ Continuing Review

Application’ from the ‘Select A Document’ drop down box.. From here, choose

File>Save As to save the document to your computer, complete the Continuing

Review Application Form, save it to your hard drive, and use the checklist as a reference.

View the On-Line Document (IRB Registration Form) and verify that the data accurately reflects the current status of your study. If changes have occurred to your study that have not previously been reviewed and approved by the IRB, then an amendment/modification will be required (see Section IV).

Attach supporting documents for your continuing review package by clicking on the ‘Add New Document’ button and browsing your computer:

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In the Document Type drop-down box, pick the best match for the document you are uploading. If it is the application, choose the “Continuing Review/Progress

Report” choice. If the type of document you are submitting is not in the list then choose “Other” and enter the type of document in the Description field. Click the

Browse’ button and find the document on your hard drive. Once you find the document click the ‘Attach’ button to upload the document.

Step 6: When all required continuing review documents are uploaded, the PI needs to sign your package electronically. Send a Project email (Send Mail) to the PI for them to sign the package.

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Step 7: To sign a package, click

SIGN THIS PACKAGE

. The Principal Investigator MUST sign the package before it is submitted. Select your appropriate role from the dropdown box and click ‘Sign’.

Step 7:

Note: If a submission is submitted without the PI signature, the submission will not be accepted for review.

Once the PI has signed the package, click SUBMIT THIS PACKAGE. Select “HCA-

HealthONE IRB, Denver, CO” in the “Search for Organization” drop down menu

(This will be your default location and should be highlighted already).

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Then click the ‘Continue’ button. In the Submission Type drop-down menu, select ‘Continuing Review/Progress Report’ and click ‘Submit’.

Once you hit the “Submit” button, you will be given a confirmation showing the time your submission occurred.

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Step 8: To review what has been sent, click

PROJECT OVERVIEW

. The submission will be under ‘Pending Review’ status until a decision by the board has been made.

Once a decision letter is formulated, an email will be sent to everyone who has full access and the letter and any supporting documents can be printed.

User Tip: Keep in mind that once you click “Submit” your study is now locked. Take

the time to be sure all documents are attached and in the final version prior to

submitting. Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections.

V. INSTRUCTIONS FOR SUBMITTING AN AMENDMENT

THE SUBMISSION OF AN AMENDMENT OF AN OPEN STUDY REQUIRES THE CREATION OF A

SUBSEQUENT PACKAGE IN A PROJECT.

Step 1:

Step 2:

Login to IRBNet; www.irbnet.org

. This will take you to the

MY PROJECTS

page.

Click on the Title of the project that you would like to amend/modify. Then click on the

PROJECT HISTORY

Step 3: Click on the

CREATE NEW PACKAGE

button and then the

NEW DOCUMENT

PACKAGE

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A

NEW DOCUMENT PACKAGE

will appear as a “Work in Progress”. Click on the

New Document

Package

title and you will be brought to the

DESIGNER

screen where you can add your documents for this package.

Step 4: You will now be on the

DESIGNER

page.

This is where you can access the library of forms as well as any documents from previous packages you have submitted.

From the HCA-HealthONE IRB Library (Step 1 – top of screen), Select and download both ‘Checklist – Amendment/Modifications’ and

‘Amendment/Modification Application’ from the ‘Select A Document’ drop down box. From here, choose File>Save As to save the amendment document to your computer, complete the Application Form, save to your hard drive and use the checklist as a reference guide.

If the amendment changes any of the data included in the previously approved On-

Line Document (IRB Registration Form), i.e., personnel, study locations, contact information, then this form will need to be updated as a part of your amendment submission.

Attach supporting documents for your amendment package by clicking on the ‘Add

New Document’ button and browsing your computer:

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In the Document Type drop-down box, pick the best match for the document you are uploading. If it is the application, choose the “Application Form” choice. If the type of document you are submitting is not in the list then choose “Other” and enter the type of document in the Description field. Click the ‘Browse’ button and find the document on your hard drive. Once you find the document click the

Attach’ button to upload the document.

Repeat the steps to upload until all documents have been uploaded to your package.

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Step 5:

Step 6:

When all documents are uploaded the PI needs to sign the package electronically.

Send an e-mail (Send Project Mail) to the PI and have them

SIGN THIS PACKAGE

.

To sign a package, click

SIGN THIS PACKAGE

. The Principal Investigator MUST sign the package before it is submitted. Select your appropriate role from the dropdown box and click ‘Sign’.

Step 7: Once the PI has signed the package, click

SUBMIT THIS PACKAGE

. Select “HCA-

HealthONE IRB, Denver, CO” in the “Search for Organization” drop down menu

(This will be your default location and should be highlighted already).

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Then click the ‘Continue’ button. In the Submission Type drop-down menu, select

‘Amendment/Modification’ and click ‘Submit’.

Once you hit the “Submit” button, you will be given a confirmation showing the time your submission occurred.

Step 8: To review what has been sent, click

PROJECT OVERVIEW

. The submission will be under ‘Pending Review’ status until a decision has been made. Once a decision letter is formulated, an email will be sent to everyone who has full access and the letter and any supporting documents can be printed.

User Tip: Keep in mind that once you click “Submit” your study is now locked and

you can no longer make any other changes to this package. Take the time to be sure

all documents are attached and in the final version prior to submitting. Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections.

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VI. INSTRUCTIONS FOR SUBMITTING A STUDY CLOSURE

THE SUBMISSION OF A STUDY CLOSURE OF AN OPEN STUDY REQUIRES THE CREATION OF A

SUBSEQUENT PACKAGE IN A PROJECT.

Step 1:

Step 2:

Login to IRBNet; www.irbnet.org

. This will take you to the

MY PROJECTS

page.

Click on the Title of the project that you would like to close. Then click on the

PROJECT HISTORY

Step 3: Click on the

CREATE NEW PACKAGE

button

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A

NEW DOCUMENT PACKAGE

will appear as a “Work in Progress”. Click on the

New Document

Package

title and you will be brought to the

DESIGNER

screen where you can add your documents for this package.

Step 4: You will now be on the

DESIGNER

screen where you can add your documents for this package.

From the HCA-HealthONE IRB Library (Step 1 – top of screen), Select and download ‘Final Report Application’ from the ‘Select A Document’ drop down box.

From here, choose File>Save As to save the document to your computer, complete the Application Form and save to your hard drive.

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Attach supporting documents for your amendment package by clicking on the ‘Add

New Document’ button and browsing your computer:

Step 5: Attach supporting documentation for your closure of the study. In the ‘Document

Type’ box, pick the Closure/Final Report document type in the drop-down box. If the type of document you are submitting is not in the list then choose ‘Other’ and enter the type of document in the Description field. Click the ‘Browse’ button and find the document on your hard drive. Once you find the document, click the

Attach’ button to upload the document.

Step 6:

Repeat the steps to upload until all documents have been uploaded to your package.

When all required documents are uploaded to the package, the PI needs to

SIGN

THIS PACKAGE

electronically. In order to sign a package, select your appropriate role from the dropdown box and click ‘Sign’.

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Note: If a submission is submitted without the PI signature, the submission will not be accepted for review.

Step 7: Once the PI has signed the package, click SUBMIT THIS PACKAGE. Select “HCA-

HealthONE IRB, Denver, CO” in the “Search for Organization” drop down menu

(This will be your default location and should be highlighted already).

Then click the ‘Continue’ button. In the Submission Type drop-down menu, select

‘Closure/Final Report’ and click ‘Submit’.

Once you hit the “Submit” button, you will be given a confirmation showing the time your submission occurred.

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Step 8: To review what has been sent, click

PROJECT OVERVIEW

. The submission will be under ‘Pending Review’ status until an acknowledgement is granted. Once a decision letter is formulated, an email will be sent to everyone who has full access and the letter and any supporting documents can be printed.

User Tip: Keep in mind that once you click “Submit” your study is now locked and no

other changes can be made to this package. Take the time to be sure all documents

are attached and in the final version prior to submitting. Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections.

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VII. INSTRUCTIONS FOR SUBMITTING ADVERSE EVENTS or EXTERNAL

SAE’S FROM SPONSOR AND REPORTABLE EVENTS

INCLUDING REPORTABLE EVENTS (Non AE) SUCH AS LOCAL AEs, PROTOCOL DEVIATIONS,

UNANTICIPATED PROBLEMS, OR COMPLIANCE CONCERNS

THE SUBMISSION WILL REQUIRE THE CREATION OF A SUBSEQUENT PACKAGE IN A

PROJECT.

If you are unsure whether to submit as an Adverse Event or a Reportable Event, consult the

HCA-HealthONE IRB website for guidance or call the administrative office at 303-584-2300.

Step 1: Login to IRBNet; www.irbnet.org

. This will take you to the

MY PROJECTS

page

Step 2: Click on the Title of the project of which you are reporting. Then click on

PROJECT

HISTORY

button

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Step 3: Click on the

CREATE NEW PACKAGE

button

A

NEW DOCUMENT PACKAGE

will appear as a “Work in Progress”. Click on the

New Document

Package

title and you will be brought to the

DESIGNER

screen where you can add your documents for this package.

Step 4: You will now be on the

DESIGNER

screen where you can add your documents for this package.

From the HCA-HealthONE IRB Library (Step 1 – top of screen), Select and download the appropriate form for your submission type (i.e., Adverse Event

Report Form, Protocol Deviation Report Form, etc.) from the ‘Select A Document’ drop down box. From here, choose File>Save As to save the document to your computer, complete the appropriate form(s) and save to your hard drive.

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Add supporting documentation to your submission such as sponsor reports, etc.

Attach supporting documents for your package by clicking on the ‘Add New Document’ button and browsing your computer:

Label your documents appropriately using the drop down list on the ‘Attach

Document’ screen (i.e., Adverse Event Report, Report, Protocol Deviation/Violation

Report, Unanticipated Problem Report, Letter, etc).

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Step 5: When all required documents are uploaded to the package, the PI needs to

SIGN

THIS PACKAGE

electronically. In order to sign a package, select your appropriate role from the dropdown box and click ‘Sign’.

Note: If a submission is submitted without the PI signature, the submission will not be accepted for review.

Step 6: Once the PI has signed the package, click SUBMIT THIS PACKAGE. Select “HCA-

HealthONE IRB, Denver, CO” in the “Search for Organization” drop down menu

(This will be your default location and should be highlighted already).

Then click on the ‘Continue’ button.

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In the Submission Type drop-down menu, select the appropriate submission type, either ‘Adverse Event’ or ‘Reportable Event (Non-AE)’ or ‘Protocol Deviation’ and click ‘Submit’.

Once you hit the “Submit” button, you will be given a confirmation showing the time your submission occurred.

To review what has been sent, click

PROJECT OVERVIEW

. The submission will be under ‘Pending Review’ status until an acknowledgement is granted or an action has been taken. Once a decision letter is formulated, an email will be sent to everyone who has full access and the letter and any supporting documents can be printed.

User Tip: Keep in mind that once you click “Submit” your study is now locked and no

other changes can be made to this package. Take the time to be sure all documents

are attached and in the final version prior to submitting. Any incomplete submissions will not be reviewed by the IRB and will be returned for corrections.

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VIII. INSTRUCTIONS FOR SUBMITTING REVISIONS REQUESTED

BY THE BOARD (MODIFICATIONS REQUIRED)

If you have submitted a package and the IRB has determined that “Modifications are Required”, then you need to submit a ‘Revision’.

Step 1: Login to IRBNet; www.irbnet.org

. This will take you to the

MY PROJECTS

page.

Step 2: Click on the Title of the project of which you submitting revisions. Then click on the

PROJECT HISTORY

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Step 3: Click on the

CREATE NEW PACKAGE

button and then the

NEW DOCUMENT

PACKAGE

A

NEW DOCUMENT PACKAGE

will appear as a “Work in Progress”. Click on the

New Document

Package

title and you will be brought to the

DESIGNER

screen where you can add your documents for this package.

Step 4: You will now be on the

DESIGNER

screen where you can add your documents for this package.

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2. To revise an uploaded document (.doc, .xls, .pdf, etc.) from a previous package:

• First download the document by clicking on its Document Type or the paper icon. Note: If

you will be revising a consent document, be careful to ensure that the document in your designer that you will be downloading and revising is identical to the most current, stamped,

IRB-approved version that sits in the Board Documents Section [See Review Details Page]

• Make necessary changes and save the revised document to your computer. Be sure to include both a tracked changes version of your document showing what is changing as well as a clean copy for approval.

Helpful Hint: You can find instructions on how to use ‘tracked changes’ under the Forms and

Templates tab under ‘Other Tools’. Look for the document entitled ‘GUIDANCE – How to Use

Track Changes in Documents’.

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• Click on the pencil icon for that document in the Designer.

Browse your computer and select your revised version of the document to upload, make changes to the Document Type and Description as appropriate, and click the Update button.

An icon will now show that there are multiple documents to be viewed. This will allow a reviewer (and you) to see the original document and the revised document in one place.

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If you need to add a new document, then click on the ‘Add New Document’ button.

3. To revise

the IRB Registration Form

from a previous package for committee review:

• Click on the pencil icon for the Registration Form.

• This will open up the IRB Registration Form (IRBNet Document Wizard screen).

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• Use the Jump To: feature in the upper right corner of the IRBNet Document Wizard page to Jump to the section that you are revising

• Click on the Save and Exit button when you have made all of your changes

• The document will move to the ’New and Revised Documents in this Package’ section on the

DESIGNER

page.

Step 5: Click

SIGN THIS PACKAGE

. The PI signature is required for all submissions

The lead researcher should sign as “Principal Investigator”. Studies will not be scheduled for review if the PI has not signed off on the Revisions.

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Step 6: Click on

SUBMIT THIS PACKAGE

; click on “HCA-HealthONE IRB, Denver, CO in the

‘Select Organization’ box. Then click on ‘Continue’

In the Submission Type drop-down menu, select ‘Revisions’ and click ‘Submit’

In the “Your Comments” section, specify what the revision is for - i.e., response to new study submission, amendment submission, continuing review submission, etc. This will assist the board in processing your revision in a timelier manner.

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To review what has been sent, click

PROJECT OVERVIEW

. The submission will be under ‘Pending

Review’ status until a decision has been made.

Helpful Hints:

Take the time to be sure all documents are attached and in the final version prior to

submitting. Any incomplete submissions will be unlocked and will not be reviewed by the IRB. An e-mail will be sent to identify the missing documents or items in the package.

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IX. INSTRUCTIONS FOR SUBMITTING REVISIONS REQUESTED BY

THE HCA-HealthONE IRB Administrative Office [Incomplete

Submissions]

You will receive an email that lists what is missing or what changes need to made to your document.

Step 1: Login to IRBNet; www.irbnet.org

. This will take you to the

MY PROJECTS

page

Step 2: Click on the Title of the project of which you are submitting missing/corrected documents.

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Step 3: Click the

DESIGNER

.

From here, you can upload revised documents for your study by clicking on ‘Add

New Document’. Browse for your revised documents and any other relevant information from your computer and assign the proper Document Type from the drop down menu. Click ‘Attach’.

Step 4: To relock the package, Click on ‘

Mark Revisions Complete

.’

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Step 5: Check the status of your review. Go to

Review Details

Review Details include Agenda Date, Review Type, Status, Effective and Expiration

Dates, and Board Documents

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X. INSTRUCTIONS FOR SUBMITTING OTHER SUBMISSIONS

(such as Other Correspondences or Communications from Study Sponsor)

An investigator is responsible for reporting any new information as it is obtained during the study.

Other submissions besides the submission types listed above are submitted using the same methods.

• Log-In to www.irbnet.org

• Click the appropriate title of the study

• Access the Designer

• Click the ‘Add New Document’ icon

• Attach the Document

• Have the PI Sign the Package

• Submit the package to the appropriate IRB (HCA-HealthONE IRB, Denver, CO) by designating the ‘Other’ Submission Type.

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FAQ’s:

What studies do I have access to?

The

MY PROJECTS

screen can be found by clicking on “My Projects’ on the left side of your screen.

This will show you the list of studies to which you have access – those you have created and those which have been shared with you. Studies which have not been submitted are labeled “Work in

Progress” in the Status column. Studies which have been submitted but not reviewed by the IRB are labeled “Pending Review.”

Clicking on the title of any project will take you to the

PROJECT OVERVIEW

page for the selected project which contains project details.

What if I submit an incomplete package?

If you have forgotten to add a necessary document or need to make a quick change to a recently submitted project package, contact the HCA-HealthONE IRB administrative office at 303-584-2300.

My PI says he signed up in IRBNet but I cannot share the project with him?

Anyone can trigger an Activation email by logging into their account on IRBNet and clicking the link provided. If they are not finding the Activation email in their inbox, please have them check their Spam folder. Once they open the Activation email, clicking the link provided will activate his account and allow him/her to log in on IRBNet.

How do I know if my PI has signed the package?

To know when your PI has signed off on a package, ask them to click the send mail button when they have signed. This will send an automatically generated email from them letting you know they have signed. If they do not do this, you can log-in and review if they have signed by clicking on the

SIGN THIS PACKAGE

tab on the left of your screen. This will bring you to a list of who has signed this study and when it was completed.

What level of access should the members of your study team have?

It is up to you to decide what kind of access shared individuals should have. It bears repeating: only the principal investigator and maybe one other (a study coordinator) should have full access to edit and submit the project to the HCA-HealthONE IRB. Those with full access will receive emails when the IRB posts an action or decision.

How do I “Un-share” a project with someone?

When personnel leave a study, it is very important to complete an amendment to notify the IRB of the change, and also to remove their access to the study. Follow the same steps in

SHARE THIS

PROJECT

and click on “No Access”.

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What are those little red flags and how do I use them?

The Project Reminders flag lets you know when an important message or alert has arrived. Simply click on the Project Reminders flag to view these messages and alerts. As you review each message and alert, be sure to "Silence" each personal Reminder flag if you no longer need to be reminded. Note that silencing your personal Reminder flags helps you to manage your personal project list and does not affect other users. By making sure to Silence the flags you no longer need, you'll be able to easily see when new messages and alerts arrive because the Project Reminders flag will automatically turn back on.

What are Project Tags and how do I use them?

Use Tags to organize your projects, track tasks and status, and share important information with other users. When you tag a project you can choose if you want to keep the Tag personal (only you can see it) or if you want to share the Tag so it can also be seen by others (note that you can only share your Tags if you have Full or Write access to the project). For example, you may want to add a personal Tag to remind yourself of items on your individual to-do list, or you may want to add a shared Tag to let everyone on the project team know that they need to update their training credentials before your next submission. Note that shared Tags can be removed by any user that has Write or Full access to your project

How do I Archive my projects?

You can help keep your workspace clean by Archiving projects that you no longer need to see in your active project list. Note that archiving projects helps you to manage your personal project list and does not affect other users. Archived projects can be viewed at any time by clicking "Show

Archived Projects" and can also be Un-Archived at any time if you want them back in your active project list. For example, if you are an advisor or department chair that has to sign-off on large numbers of projects, you'll probably find it useful to Archive projects once you have signed off to help keep your active project list manageable.

You should note that even if you have Archived a project it will still appear in your active projects list if you have Reminders (for example, if you receive a new message or alert). Therefore, to make the most of project Archiving you should be sure to regularly review and silence your Reminders.

What does my electronic signature mean?

The HCA-HealthONE IRB requires that the Principal Investigator sign each submission.

If you are the Principal Investigator, your electronic signature that is associated with a given project means that the research described in the application and supporting materials will be conducted in full compliance with HCA-HealthONE IRB’s Policies and Federal regulations governing human subject research. Furthermore, you will:

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• Ensure that all aspects of the project will be conducted by the study team as approved by the HCA-HealthONE IRB

• Promptly report any revisions or amendments to the research activity for review and approval by the HCA-HealthONE IRB prior to commencement of the revised protocols, with the only exception to this policy being those situations where changes in protocol are required to eliminate apparent, immediate hazards to the subject,

• Promptly report any unanticipated problems or serious adverse events affecting risk to subjects or others,

• Assume full responsibility for selecting subjects in strict accordance with the inclusion/exclusion criteria outlined in the application materials,

• Use only HCA-HealthONE IRB-approved, stamped consent forms for studies in which consent form(s) have been approved for the research activity, and

• Ensure that all personnel involved with human subjects, or human data and/or biological specimens during the course of this research activity are trained in the Protection of

Human Subjects and HIPAA in Research, in full accordance with HCA-HealthONE IRB policy on this matter.

If you are a co-investigator, your electronic signature that is associated with a given project means that:

• You are fully cognizant of the details of the protocol, and will conduct all aspects of the project as approved by HCA-HealthONE IRB

• You will promptly report to the Principal Investigator any unanticipated problems or serious adverse events affecting risk to subjects or others

• You will not be involved in any aspect of the project for which you have not been trained, or conduct any procedure in which you are not certified/licensed.

Locked vs. Unlocked Status

Once a study is submitted to the IRB, it will be LOCKED.

P ackages can only be unlocked by HCA-HealthONE IRB Administrative staff. This can be done if you let us know that you’ve made an error in something that you just submitted, or if we let you know that we see something that is missing or needs to be fixed. When you need to respond to a

HCA-HealthONE IRB review, or if you want to submit an amendment, or continuing review, you will

CREATE NEW PACKAGE

for the project by adding documents in the designer for that project.

See sections I - IX for details.

The numbering system in IRBNet (What happened to the old #’s?)

You will note 2 different #’s in the IRBNet system, IRBNet #, and Local Board Reference #:

The IRBNet # is an important ‘internal tracker’ provided through IRBNet which is assigned to all studies that you create (new and continuing). The root # stays the same from creation of a project to termination thereof. The suffix of the IRBNet # (e.g., -1, -2. -3 etc) is the ‘package #’ with which you are dealing for a single project, i.e., each new package will change the suffix of the IRBNet #. Example: So if your original submission is given the

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IRBNet # 123456-1, and the IRB reviews the submission and requires changes, you will submit your response as a new package to the original, and it will be given the IRBNet #

123456-2. If it’s then approved, and you want to add an amendment, you will submit it as a new package, it will be given the IRBNet #123456-3. And so on. If you click on ‘project history’ for IRBNet #1234567-3, you will see all the packages for the study.

The local board reference # is the old number that came over from the previous electronic system, IRB Manager. For example, 2006-111.

I have submitted a Continuing Review application, why am I still receiving an IRBNet 30-Day Project Expiration Reminder?

Reminders are automatically generated until the submission has been approved by the

IRB. If you can see the Continuing Review submission in PROJECT HISTORY the IRB staff has access to it. PROJECT HISTORY will show the Status as Pending Review until it has gone to the Board.

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Project

Project Package

Submission

Principal Investigator

Amendment/Modification

Revision

My Projects

Create New Project

EXPLANATION OF IRBNet TERMS

A Project is an online version of the research protocol being submitted to the HCA-

HealthONE IRB

A package is a submission containing any number of documents that are required by the

IRB to conduct their review of a research

Project (i.e., Initial project, amendment, continuing review, protocol deviation, etc.)

IRBNet uses the term Submission to denote a

Project Package that has been submitted for official review by the IRB

IRBNet uses the term Principal Investigator (PI) to designate the person with overall responsibility for studies submitted to the HCA-

HealthONE IRB. All studies must have a PI, and all submissions must include a PI signature.

Amendments/Modifications are changes that the researcher wishes to make after a study is approved by the IRB. The researcher must submit an Amendment/Modification package for IRB approval.

A Revision is a change (or changes) required by the Institutional Review Board before a Project or package can be approved. The researcher creates a new Project Package in IRBNet to address any required revisions.

Lists all projects you have created. You enter the study by selecting it from the list

Allows you to enter a New Study for submission. The Initial Project package will include the appropriate applications, the full research protocol, any surveys or instruments, consent forms and any other required documents.

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Project Overview

Designer

Share This Project

Sign this Package

Submit this Package

Delete this Package

Send Project Mail

Project History

Board Documents

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Summarizes the selected project, displays the status and documents. Allows you to submit the package for review, and share with other

IRBNet users

This page contains two steps. Step 1 lists the document library where you can find forms to guide you or to fill out (i.e., checklists, applications). Step 2 allows you to upload your documents to a package. This is called

“Assemble your document package’. This means you are putting your proposal together

Allows you to share your project with other researchers

All packages must include the Principal

Investigator signature prior to submission

After the PI signs the package, you will need to submit the package to the HCA-HealthONE IRB.

Once you submit a package, it remains in the system permanently.

If you want to remove the package completely, this cannot be undone.

Allows you to send an e-mail between members of the project team

Lists the Actions related to this project

These are decision documents and stamped documents issued by the board in response to your package submission

HOW TO LABEL YOUR SUBMISSIONS

When submitting the following items, use the appropriate SUBMISSION TYPE within IRBNet:

ITEM

Exempt Initial Submission

SUBMISSION TYPE

New Project

Expedited/Convened IRB Initial Submission

Continuing Review

Amendment

Consent Revision

Protocol Revision

Information from Sponsor/Notification to the

IRB

Study Closure

Response to Approval with Modifications from the IRB

Response to Additional Materials Request or follow-up from the IRB

Correspondence

Any Communications from Sponsor that do not require an amendment (i.e., DSMB’s,

Investigator Brochures, Clarification Memos,

Package Inserts)

External SAE’s from Sponsor

Local SAEs

Protocol Deviation

Unanticipated Problem

Compliance Concern

New Project

Continuing Review/Progress Report

Amendment/Modification

Amendment/Modification

Amendment/Modification

Amendment/Modification

Closure/Final Report

Revision

Revision

Other

Other

Adverse Event

Reportable Event/(Non AE)

Reportable Event/(Non AE)

Reportable Event/(Non AE)

Reportable Event/ (Non AE)

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