SAS Clinical Standards Toolkit 1.4 Installation Qualification

SAS  Clinical Standards Toolkit 1.4 Installation Qualification
SAS
Clinical Standards Toolkit 1.4
®
Installation Qualification
The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2011. SAS Clinical
Standards Toolkit 1.4: Installation Qualification. Cary, NC: SAS Institute Inc.
®
SAS® Clinical Standards Toolkit 1.4: Installation Qualification
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iii
Contents
Chapter 1 Installation Qualification 1
Purpose 2
Notes and Assumptions 2
Test 1: SDTM 3.1.1 Validation 4
Introduction 4
Steps 4
Sign-Off 7
Test 2: SDTM 3.1.1 Report Process Results 8
Introduction 8
Steps 8
Sign-Off 9
Test 3: SDTM 3.1.2 Validation 10
Introduction 10
Steps 10
Sign-Off 11
Test 4: SDTM 3.1.2 Build Source Data 12
Introduction 12
Steps 12
Sign-Off 13
Test 5: SDTM 3.1.2 Build Source Metadata 14
Introduction 14
Steps 14
Sign-Off 15
Test 6: SDTM 3.1.2 Build SAS Formats 16
Introduction 16
Steps 16
Sign-Off 17
Test 7: SDTM 3.1.2 Report Check Metadata 18
Introduction 18
Steps 18
Sign-Off 19
Test 8: CRT-DDS Validate 20
Introduction 20
Steps 20
Sign-Off 20
Test 9: CRT-DDS Create SAS CRT-DDS from SDTM 21
Introduction 21
iv
Contents
Chapter Error! No text of specified style in document.
Steps 21
Sign-Off 21
Test 10: CRT-DDS Create SAS CRT-DDS from Define.xml 22
Introduction 22
Steps 22
Sign-Off 23
Test 11: CRT-DDS Import from XML Export to XML (Round Trip) 24
Introduction 24
Steps 24
Sign-Off 25
Test 12: CRT-DDS Create Define.xml 26
Introduction 26
Steps 26
Sign-Off 27
Test 13: ODM 1.3.0 Create SAS ODM from XML 28
Introduction 28
Steps 28
Sign-Off 29
Test 14: ODM 1.3.0 Validate SAS ODM 30
Introduction 30
Steps 30
Sign-Off 31
Test 15: ODM 1.3.0 Create ODM XML from SAS ODM 32
Introduction 32
Steps 32
Sign-Off 32
Test 16: ODM 1.3.0 Find Unsupported Tags in ODM XML 33
Introduction 33
Steps 33
Sign-Off 33
Test 17: SDTM Controlled Terminology 201104 34
Introduction 34
Steps 34
Sign-Off 35
Test 18: ADaM Controlled Terminology 201101 36
Introduction 36
Steps 36
Sign-Off 37
Test 19: CDASH Controlled Terminology 201104 38
Introduction 38
Steps 38
Sign-Off 39
v
Test 20: ADaM 2.1 Validation 40
Introduction 40
Steps 40
Sign-Off 42
Test 21: ADaM 2.1 Report Process Results 43
Introduction 43
Steps 43
Sign-Off 44
Final Sign-Off 45
vi
Contents
Chapter Error! No text of specified style in document.
1
C H A P T E R
1
Installation Qualification
Purpose .......................................................................................................................................................... 2
Notes and Assumptions ................................................................................................................................. 2
Test 1: SDTM 3.1.1 Validation...................................................................................................................... 4
Introduction............................................................................................................................................ 4
Steps ....................................................................................................................................................... 4
Sign-Off .................................................................................................................................................. 7
Test 2: SDTM 3.1.1 Report Process Results .................................................................................................. 8
Introduction............................................................................................................................................ 8
Steps ....................................................................................................................................................... 8
Sign-Off .................................................................................................................................................. 9
Test 3: SDTM 3.1.2 Validation.................................................................................................................... 10
Introduction.......................................................................................................................................... 10
Steps ..................................................................................................................................................... 10
Sign-Off ................................................................................................................................................ 11
Test 4: SDTM 3.1.2 Build Source Data ....................................................................................................... 12
Introduction.......................................................................................................................................... 12
Steps ..................................................................................................................................................... 12
Sign-Off ................................................................................................................................................ 13
Test 5: SDTM 3.1.2 Build Source Metadata ............................................................................................... 14
Introduction.......................................................................................................................................... 14
Steps ..................................................................................................................................................... 14
Sign-Off ................................................................................................................................................ 15
Test 6: SDTM 3.1.2 Build SAS Formats ..................................................................................................... 16
Introduction.......................................................................................................................................... 16
Steps ..................................................................................................................................................... 16
Sign-Off ................................................................................................................................................ 17
Test 7: SDTM 3.1.2 Report Check Metadata ............................................................................................... 18
Introduction.......................................................................................................................................... 18
Steps ..................................................................................................................................................... 18
Sign-Off ................................................................................................................................................ 19
Test 8: CRT-DDS Validate .......................................................................................................................... 20
Introduction.......................................................................................................................................... 20
Steps ..................................................................................................................................................... 20
Sign-Off ................................................................................................................................................ 20
Test 9: CRT-DDS Create SAS CRT-DDS from SDTM ............................................................................... 21
Introduction.......................................................................................................................................... 21
Steps ..................................................................................................................................................... 21
Sign-Off ................................................................................................................................................ 21
Test 10: CRT-DDS Create SAS CRT-DDS from Define.xml....................................................................... 22
Introduction.......................................................................................................................................... 22
Steps ..................................................................................................................................................... 22
Sign-Off ................................................................................................................................................ 23
Test 11: CRT-DDS Import from XML Export to XML (Round Trip).......................................................... 24
Introduction.......................................................................................................................................... 24
Steps ..................................................................................................................................................... 24
Sign-Off ................................................................................................................................................ 25
Test 12: CRT-DDS Create Define.xml ......................................................................................................... 26
Introduction.......................................................................................................................................... 26
Steps ..................................................................................................................................................... 26
Sign-Off ................................................................................................................................................ 27
Test 13: ODM 1.3.0 Create SAS ODM from XML ....................................................................................... 28
Introduction.......................................................................................................................................... 28
Steps ..................................................................................................................................................... 28
2
Notes and Assumptions
Chapter 1
Sign-Off ................................................................................................................................................ 29
Test 14: ODM 1.3.0 Validate SAS ODM ..................................................................................................... 30
Introduction.......................................................................................................................................... 30
Steps ..................................................................................................................................................... 30
Sign-Off ................................................................................................................................................ 31
Test 15: ODM 1.3.0 Create ODM XML from SAS ODM ............................................................................. 32
Introduction.......................................................................................................................................... 32
Steps ..................................................................................................................................................... 32
Sign-Off ................................................................................................................................................ 32
Test 16: ODM 1.3.0 Find Unsupported Tags in ODM XML ....................................................................... 33
Introduction.......................................................................................................................................... 33
Steps ..................................................................................................................................................... 33
Sign-Off ................................................................................................................................................ 33
Test 17: SDTM Controlled Terminology 201104......................................................................................... 34
Introduction.......................................................................................................................................... 34
Steps ..................................................................................................................................................... 34
Sign-Off ................................................................................................................................................ 35
Test 18: ADaM Controlled Terminology 201101 ......................................................................................... 36
Introduction.......................................................................................................................................... 36
Steps ..................................................................................................................................................... 36
Sign-Off ................................................................................................................................................ 37
Test 19: CDASH Controlled Terminology 201104 ...................................................................................... 38
Introduction.......................................................................................................................................... 38
Steps ..................................................................................................................................................... 38
Sign-Off ................................................................................................................................................ 39
Test 20:ADaM 2.1 Validation ...................................................................................................................... 40
Introduction.......................................................................................................................................... 40
Steps ..................................................................................................................................................... 40
Sign-Off ................................................................................................................................................ 42
Test 21: ADaM 2.1 Report Process Results.................................................................................................. 43
Introduction.......................................................................................................................................... 43
Steps ..................................................................................................................................................... 43
Sign-Off ................................................................................................................................................ 44
Final Sign-Off .............................................................................................................................................. 45
Purpose
This document explains how to verify that SAS Clinical Standards Toolkit 1.4 has
been installed correctly and is functioning properly. The installation is tested by
running a series of SAS programs. These tests must be run in the sequence presented.
Notes and Assumptions
SAS 9.3 has been installed and is functioning correctly; it is not being tested.
 The SAS Clinical Standards Toolkit 1.4 has been installed.
 The person running these tests is familiar with running SAS programs. This
includes being able to submit SAS programs via the Program Editor, review the
SAS log, and review the contents of SAS data sets.
 This document is used for both the UNIX and Microsoft Windows environments.
The forward slash character ( / ) is used in file paths as the separator between
path components, which works in both operating system environments.

Installation Qualification
Notes and Assumptions
3
Within this document:
 SASINSTALL is used to denote the SAS Installation Folder. This is the
folder into which all SAS products are installed.
 The default value for SAS 9.3 on Microsoft Windows is C:/Program
Files/SASHome.
 The default value varies on UNIX machines, please consult your system
administrator.
 SASROOT is used to denote the root folder for the SAS System installation.
 The default value for SAS 9.3 is SASINSTALL/SASFoundation/9.3.
 The tests refer to the following variables, which are defined relative to
SASINSTALL. When running the tests, substitute the variables with the
following associated paths.
 CST_SDTM_311
SASINSTALL/SASClinicalStandardsToolkitSDTM311/1.4/sample/cdiscsdtm-3.1.1/sascstdemodata
 CST_SDTM_312
SASINSTALL/SASClinicalStandardsToolkitSDTM312/1.4/sample/cdiscsdtm-3.1.2/sascstdemodata
 CST_ODM
SASINSTAL/SASClinicalStandardsToolkitODM130/1.4/sample/cdisc-odm1.3.0
 CST_CRTDDS
SASINSTALL/SASClinicalStandardsToolkitCRTDDS10/1.4/sample/cdisccrtdds-1.0
 CST_ADAM
SASINSTALL/SASClinicalStandardsToolkitADam21/1.4/sample/cdisc-adam2.1/sascstdemodata
 Tests 2, 7, and 21 generate PDF files. On Microsoft Windows, when the PDF is
generated, a browser window should automatically appear containing the PDF for
viewing. On UNIX, if you have not set up the SAS configuration variable
SAS.helpBrowser, you get a popup message: “The requested information could not
be displayed because the connection to the remote browser server failed”. Click OK
to continue. Configure your UNIX SAS environment to support a browser that can
display PDF files or copy the PDF file to an environment where you can examine
it.

4
Test 1: SDTM 3.1.1 Validation
Chapter 1
Test 1: SDTM 3.1.1 Validation
Introduction
This test runs the sample program that ships as part of the SDTM 3.1.1 standard. If
this program runs successfully and produces the expected results, then the SDTM 3.1.1
standard is correctly installed and functioning properly.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program and select
CST_SDTM_311/programs/validate_data.sas.
3
Select Run-  Submit.
It outputs to the SAS Log and generates two SAS data sets: Validation_results
and Validation_metrics. These data sets can be found in the Results library within
the SAS Explorer window.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set Validation_results for errors.
It should be consistent with the following table. It contains additional columns,
but checking these is sufficient. Bolded values are dynamic and subject to change
at time the code is submitted.
Installation Qualification
Row
Result
Identifier
Validation
Check
Identifier
Unique
Invocation
of resultid
Seq #
within
resultseq
Test 1: SDTM 3.1.1 Validation
Source data
1 CST0108
1
1 CST_SETPROPERTIES
2 CST0102
1
1 CST_CREATEDS
3 CST0200
1
1 CSTUTIL_PROCESSSETUP
4 CST0108
1
1 CST_SETPROPERTIES
5 CST0108
1
1 CST_SETPROPERTIES
6 CST0200
1
1 SDTM_VALIDATE
7 CST0200
1
2 SDTM_VALIDATE
8 CST0200
1
3 SDTM_VALIDATE
9 CST0200
1
4 SDTM_VALIDATE
10 CST0200
1
5 SDTM_VALIDATE
11 CST0200
1
6 SDTM_VALIDATE
12 CST0200
1
7 SDTM_VALIDATE
13 CST0200
1
8 SDTM_VALIDATE
14 CST0200
1
9 SDTM_VALIDATE
15 CST00200
1
10 SDTM_VALIDATE
16 CST0025
SDTM0011
1
1 SRCDATA.SUPPAE
17 CST0025
SDTM0011
2
1 SRCDATA.SUPPAE
18 CST0025
SDTM0012
1
1 SRCDATA.SUPPAE
19–133 Many additional similar rows are reported.
N = 133
Additional columns for rows 1–18 are as follows:
5
6
Test 1: SDTM 3.1.1 Validation
Row
Chapter 1
Resolved message text from message file
Result
Severity
resultflag _cst_rc
1 The properties were processed from the PATH
c:/cstGlobalLibrary/standards/cst-framework1.4/programs/initialize.properties
Info
0
0
2 work.sasreferences was created as requested
Info
0
0
Info
3 Process setup is using this SASReferences:
C:\DOCUME~1\userid\LOCALS~1\Temp\SAS Temporary
Files\_TD2932/sasreferences
0
0
4 The properties were processed from the PATH
c:/cstGlobalLibrary/standards/cdisc-sdtm-3.1.11.4/programs/initialize.properties
Info
0
0
5 The properties were processed from the PATH
!sasroot/../../SASClinicalStandardsToolkitSDTM311/1.4/
sample/cdisc-sdtm-3.1.1/sascstdemodata/programs/
validation.properties
Info
0
0
6 PROCESS STANDARD: CDISC-SDTM
Info
0
0
7 PROCESS STANDARDVERSION: 3.1.1
Info
0
0
8 PROCESS DRIVER: SDTM_VALIDATE
Info
0
0
9 PROCESS DATE: 2011-08-05T13:59:31
Info
0
0
Info
0
0
Info
11 PROCESS SASREFERENCES:
C:\DOCUME~1\userid\LOCALS~1\Temp\SAS Temporary
Files\_TD2932/sasreferences.sas7bdat
0
0
Info
12 PROCESS STUDYROOTPATH:
!sasroot/../../SASClinicalStandardsToolkitSDTM311/1.4/sampl
e/cdisc-sdtm-3.1.1/sascstdemodata
0
0
13 PROCESS GLOBALLIBRARY: c:\cstGlobalLibrary
Info
0
0
14 PROCESS CSTVERSION: 1.4
Info
0
0
15 PROCESS CONTROLLED TERMINOLOGY SOURCE:
c:/cstGlobalLibrary/standards/cdisc-terminology-1.4/cdiscsdtm/200810/formats/cterms (Controlled Terminology
released by NCI on 2011-04-08)
Info
0
0
16 Data set not found in reference standard - compliance not
assessed
Warning:
Check
incomplete
1
0
17 Data set not found in reference standard - compliance not
assessed
Warning:
Check
incomplete
1
0
18 Data set not found in reference standard - compliance not
assessed
Warning:
Check
incomplete
1
0
10 PROCESS TYPE: VALIDATION
19–133 Many additional similar rows are reported.
N = 133
6
Close the SAS session.
Installation Qualification
Sign-Off
Test 1:SDTM 3.1.1 Validation
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 1: SDTM 3.1.1 Validation
7
8
Test 2: SDTM 3.1.1 Report Process Results
Chapter 1
Test 2: SDTM 3.1.1 Report Process Results
Introduction
This test produces a sample report based on SDTM 3.1.1 process results.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_SDTM_311/programs/cst_report.sas.
3
Select Run  Submit.
This code outputs to the SAS log and generates a PDF file. No result data set is
created.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the PDF file; it is named cstreport.pdf and is located in the folder
CST_SDTM_311/results.
As noted in the Notes and Assumptions section, this PDF file should be displayed
automatically on Microsoft Windows. If you are on UNIX, refer back to this section
for instructions for approaches for viewing the PDF.
a) All five of the following report panels should be generated.
i.
ii.
Report Summary
Process Inputs/Outputs
iii.
Process Metrics
iv.
General Process Reporting
v.
Process Results (contains many bookmarks)
b) All titles, paths, dates, etc., should appear correct.
6
Close the SAS session.
Installation Qualification
Sign-Off
Test 2: SDTM 3.1.1 Report Process Results
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 2: SDTM 3.1.1 Report Process Results
9
10 Test 3: SDTM 3.1.2 Validation
Chapter 1
Test 3: SDTM 3.1.2 Validation
Introduction
Now, run tests for SDTM 3.1.2. The tests are located in a different base directory than
those for SDTM 3.1.1. This test verifies that the files required to validate a set of SDTM
3.1.2 domains are properly defined.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program. Select
CST_SDTM_312/programs/validate_data.sas.
3
Select Run  Submit.
This program outputs to the log and creates the data sets Validation_results and
Validation_metrics. These data sets can be found in the Results library within the
SAS Explorer window.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set Validation_results.
It is located in the Results library in the Explorer.
a) For the records where the column labeled “Validation check identifier” (named
checkid) is blank, examine the message column and check for correct paths
and process metadata.
b) The column labeled “Process status” (named _cst_rc) should be 0 for all records
and there should not be any checks with result severity = ’Warning: Check not
run’.
c)
6
The data set should contain 100 records.
Review the data set Validation_metrics.
It should contain the following in the last few rows:
Metric parameter
# of distinct check invocations
13
# check invocations not run
0
Errors (severity=High) reported
0
Warnings (severity=Medium) reported
Notes (severity=Low) reported
Structural errors, warnings and notes
Content errors, warnings and notes
7
Count of records
End the current SAS session.
10
0
85
0
Installation Qualification
Sign-Off
Test 3: SDTM 3.1.2 Validation
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 3: SDTM 3.1.2 Validation 11
12 Test 4: SDTM 3.1.2 Build Source Data
Chapter 1
Test 4: SDTM 3.1.2 Build Source Data
Introduction
This test references derived data from a CRT-DDS (define.xml) file to build a library
of SDTM 3.1.2 domains.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_SDTM_312/programs/create_sasdatafromxpt.sas.
3
Select Run  Submit.
The code outputs to the SAS log and creates a data set xpt_results under
CST_SDTM_312/results and 33 data sets under CST_SDTM_312/derived/data. For
this program, the library information was cleaned up, so these files are not
immediately accessible under Libraries in the SAS Explorer. On Microsoft
Windows, you can access these files through the SAS Explorer by navigating from
within the SAS Explorer starting at the node labeled “My Computer”. On UNIX, it
is necessary for you to copy these data sets into a folder that is viewable by the
SAS Explorer (e.g., your Home Directory listed under Favorite Folders).
4
Review the log to see if there are any errors or warnings; there should not be any
errors.
You might sporadically see warnings in the SAS log such as “WARNING: Libname
<libref> is not assigned.” These occur with redundant requests to clear SAS librefs
and/or filerefs and do not indicate a problem with the SAS Clinical Standards
Toolkit installation.
5
Review the data set xpt_results.
a) Examine the “Resolved message text from message file” column (named
message) and check for correct paths and process metadata.
b) The column labeled “Process status” (named _cst_rc) should be 0 for all records
and there should not be any checks with resultseverity=’Warning: Check not
Installation Qualification
Test 4: SDTM 3.1.2 Build Source Data 13
run’.
c)
6
The data set should contain 14 records, and the last record should report
“Process completed successfully”. See the sample output in screenshot above;
values that refer to temporary folders/files or PROCESS DATE: vary.
Review the folder CST_SDTM_312/derived/data.
a) There should be 33 new SAS data sets.
b) The data set dm should have 70 records and 20 columns.
7
End the current SAS session.
Sign-Off
Test 4: SDTM 3.1.2 Build Source Data
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
14 Test 5: SDTM 3.1.2 Build Source Metadata
Chapter 1
Test 5: SDTM 3.1.2 Build Source Metadata
Introduction
This test references derived data from a CRT-DDS (define.xml) file to build a set of
SDTM 3.1.2 metadata in a structure required by SAS Clinical Standards Toolkit.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_SDTM_312/programs/create_sourcemetadata.sas.
3
Select Run  Submit.
This code outputs to the SAS log and create data sets in both the results and
derived/metadata subfolders under CST_SDTM_312. As in Test 4, the library
information was cleaned up by the program so these files are not immediately
accessible under Libraries in the SAS Explorer. On Microsoft Windows, you can
access these files through the SAS Explorer by navigating from within the SAS
Explorer starting at the node labeled “My Computer”. On UNIX, you need to copy
these data sets into a folder that is viewable by the SAS Explorer.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set srcmeta_results under CST_SDTM_312/results.
a) Examine the “Resolved message text from message file” column (named
message) and check for correct paths and process metadata.
b) The column labeled “Process status” (named _cst_rc) should be 0 for all
records.
Installation Qualification
c)
6
Test 5: SDTM 3.1.2 Build Source Metadata 15
The data set should contain 16 records. The last 3 records should report that
study reference data was created in folder CST_SDTM_312/derived/metadata.
See the sample output in screenshot above; values that refer to temporary
folders/files or PROCESS DATE: vary.
Review the folder CST_SDTM_312/derived/metadata.
a) There should be three new data sets: source_columns, source_study, and
source_tables.
b) The data set source_tables should have 33 records and 15 columns.
7
End the SAS session.
Sign-Off
Test 5: SDTM 3.1.2 Build Source Metadata
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
16 Test 6: SDTM 3.1.2 Build SAS Formats
Chapter 1
Test 6: SDTM 3.1.2 Build SAS Formats
Introduction
This test references derived data from a CRT-DDS (define.xml) file to build a SAS
format catalog representing the codelists in the CRT-DDS file.
Steps
1
Start a new SAS session
2
In the SAS Program Editor, select File  Open Program and select
CST_SDTM_312/programs/create_formatsfromcrtdds.sas.
3
Select Run  Submit.
The code outputs to the SAS log and creates data set codelist_results in
CST_SDTM_312/results and creates a catalog named cterms under
CST_SDTM_312/derived/formats. As in tests 4 and 5, the library information was
cleaned up by the program so these files are not immediately accessible under
Libraries in the SAS Explorer. On Microsoft Windows, you can access these files
through the SAS Explorer by navigating from within the SAS Explorer starting at
the node labeled “My Computer”. On UNIX, it is necessary to copy these data sets
into a folder that is viewable by the SAS Explorer. At the end of the run, the
FMTLIB output appears.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set codelist_results under CST_SDTM_312/results.
a) Examine the “Resolved message text from message file” column (named
message) and check for correct paths and process metadata.
b) The column labeled “Process status” (named _cst_rc) should be 0 for all records
and there should not be any checks with result severity=’Warning: Check not
run’.
Installation Qualification
c)
Test 6: SDTM 3.1.2 Build SAS Formats 17
The data set should contain 14 records. The last record should report “Process
completed successfully”. See the sample output in screenshot above; values
that refer to temporary folders/files or PROCESS DATE: vary.
Folder CST_SDTM_312/derived/formats should contain a catalog cterms (named
cterms.sas7bcat).
6
Open cterms and verify that it has 32 formats.
The data set can show 39 formats if it previously existed; in this case, the 32
formats are appended to the file.
7
End the current SAS session.
Sign-Off
Test 6 – SDTM 3.1.2 Build SAS Formats
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
18 Test 7: SDTM 3.1.2 Report Check Metadata
Chapter 1
Test 7: SDTM 3.1.2 Report Check Metadata
Introduction
This test verifies that all metadata about SDTM 3.1.2 validation checks is properly
installed. A sample report itemizes this metadata.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_SDTM_312/programs/cst_metadatareport.sas.
3
Select Run  Submit.
This code outputs to the SAS log and generates a PDF file named
cstcheckmetadatareport.pdf in directory CST_SDTM_312/results. No result data
set is created.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the PDF file. Sample output from Page 1 below.
a) All four of the following report sections should be generated.
i.
ii.
The Report Procedure (Check Overview)
Additional Check Details
iii.
Validation Message Details
iv.
Reference Information
b) All titles, footnotes, column headers, and cell contents should appear correct.
Installation Qualification
c)
6
In the Reference Information section, look for at least one value of
“OpenCDISC” in the column named Source of Information (e.g., the row for
validation check SDTM0231).
End the current SAS session.
Sign-Off
Test 7 – SDTM 3.1.2 Report Check Metadata
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 7: SDTM 3.1.2 Report Check Metadata 19
20 Test 8: CRT-DDS Validate
Chapter 1
Test 8: CRT-DDS Validate
Introduction
This test validates a SAS representation of the metadata and data that is defined in
the SAS representation of the CRT-DDS model.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_CRTDDS/Programs/validate_crtdds_data.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates a validation_results data set and a
validation_metrics data set under CST_CRTDDS/results. This code can fill up the
LOG window if running interactively. If so, save the output of the log to a file
when prompted to do so.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the validation_results data set under CST_CRTDDS/results.
In the SAS Explorer, you can also view it as Validation_results in the Results
library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The data set should contain 196 records.
c)
6
In rows 15 and 16, there should be two records with Warning: Check not run.
Both of these records have checkid="CRT0100" and resultid="CST0022".
Review the data set validation_metrics under CST_CRTDDS/results.
In the SAS Explorer, you can also view it as Validation_metrics in the Results
library.
a) The data set should contain 329 records.
b) The last record should report that there were 21 records with "Content errors,
warnings and notes".
7
End the current SAS session.
Sign-Off
Test 8 – CRT-DDS Validate
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Installation Qualification
Test 9: CRT-DDS Create SAS CRT-DDS from SDTM 21
Test 9: CRT-DDS Create SAS CRT-DDS from SDTM
Introduction
If this program runs successfully and produces the expected results, then the SAS
Clinical Standards Toolkit has derived CRT-DDS metadata from an SDTM study as a
prerequisite to building a define.xml file in Test 12.
Steps
1
Start a new SAS session, and submit the CRT-DDS Create sample program
CST_CRTDDS/programs/create_crtdds_from_sdtm.sas.
The sample program outputs to the SAS Log and creates 39 data sets in folder
CST_CRTDDS/data and a results data set in the folder CST_CRTDDS/results
folder.
2
Review the log to see if there are any errors or warnings; there should not be any.
3
Review the folder CST_CRTDDS/data.
a) There should be 39 new SAS data sets.
b) The data set codelists should have 32 records and 5 columns.
4
Close the SAS session.
Sign-Off
Test 9 – CRT-DDS Create SAS CRT-DDS from SDTM
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
22 Test 10: CRT-DDS Create SAS CRT-DDS from Define.xml
Chapter 1
Test 10: CRT-DDS Create SAS CRT-DDS from Define.xml
Introduction
This test creates a CRT-DDS SAS representation files from the define.xml.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_CRTDDS/Programs/create_sascrtdds_fromxml.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates the SAS representation of the CRTDDS data sets under CST_CRTDDS/deriveddata.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set read_results under CST_CRTDDS/results.
In the SAS Explorer, you can also view it as Read_results in the Results library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The column named resultflag should be 0 for all records.
c)
The data set should contain 45 records.
d) There should be a record, with scrdata="CRTDDS_READ", reporting that the
define.xml file was read successfully.
e) There should be a record, with srcdata="JAVA CHECK"; the record should
report “No java issues”.
6
The folder CST_CRTDDS/deriveddata should contain 39 SAS data sets
representing the SAS interpretation of the CRT-DDS format.
7
Open the clitemdecodetranslatedtext SAS data set. It should contain 2909
observations. Below is a screen shot of the first 17 observations.
Installation Qualification
8
End the current SAS session.
Sign-Off
Test 10 – CRT-DDS Create SAS CRT-DDS from Define.xml
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 10: CRT-DDS Create SAS CRT-DDS from Define.xml 23
24 Test 11: CRT-DDS Import from XML Export to XML (Round Trip)
Chapter 1
Test 11: CRT-DDS Import from XML Export to XML (Round Trip)
Introduction
This test reads a CRT-DDS define.xml and creates the 39 SAS data sets in the Work
library representing the CRTDDS model. It then exports these generated data sets and
creates a CRT-DDS define.xml file. This verifies the round tripping from XML to data to
XML.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_CRTDDS/Programs/import_sascrtdds_fromxml_export_toxml.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates a define1-0-0.xsl and a
define_export.xml under CST_CRTDDS/sourcexml. It also creates a data set,
import_results, under CST_CRTDDS/results.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data in the work directory under the SAS Explorer.
There are 39 data sets representing SAS interpretation of the CRTDDS model.
These data sets do not contain any underscores in their names.
6
Review the data set import_results under CST_CRTDDS/results.
In the SAS Explorer, you can also view it as Import_results in the Results library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The column named resultflag should be 0 for all records.
c)
The data set should contain 43 records.
d) There should be a record, with scrdata="CRTDDS_READ", reporting that the
define_import.xml file was read successfully.
e) There should be a record, with srcdata="JAVA CHECK", should report “No
java issues”.
7
Review the data set export_results under CST_CRTDDS/results.
In the SAS Explorer, you can also view it as Export_results in the Results library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The column named resultflag should be 0 for all records.
c)
The data set should contain 97 records.
d) There should be a record, with scrdata="CRTDDS_WRITE", reporting that the
define_export.xml file was created (row76).
e) There should be a record, with srcdata="JAVA CHECK", should report “No
java issues” (row 78).
8
Under CST_CRTDDS/sourcexml, the define_import.xml and define_exporet.xml
should be the same size of 201 KB.
Installation Qualification
9
Test 11: CRT-DDS Import from XML Export to XML (Round Trip) 25
Click the define_export.xml file to open it and click Vital Signs next to the VS
table.
This takes you to the VS table. Click the variable VSTESTCD.
10 In the next screen, click the SIZE variable in the VSTESTCD–FRMSIZE row.
The table should look like the following:
11 End the current SAS session.
Sign-Off
Test 11 – CRT-DDS Import from XML Export to XML (Round Trip)
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
26 Test 12: CRT-DDS Create Define.xml
Chapter 1
Test 12: CRT-DDS Create Define.xml
Introduction
If this program runs successfully and produces the expected results, then the SAS
Clinical Standards Toolkit Java and XML-related libraries have been installed correctly.
The SAS Clinical Standards Toolkit and libraries can be used to create a CRT-DDS
(define.xml) file.
Steps
1
Start a new SAS session and submit the CRT-DDS Create Define.xml sample
program CST_CRTDDS/programs/create_crtdds_define.sas.
It writes to the SAS Log and generates two files in CST_CRTDDS/sourcexml and a
results data set in the folder CST_CRTDDS/results folder.
2
Review the log to see if there are any errors or warnings; there should not be any.
3
Two files should have been generated in CST_CRTDDS/sourcexml: define.xml and
define1-0-0.xsl.
4
You need to examine the define.xml in a Web browser.
On Microsoft Windows, you can open it by double-clicking it in the SAS Program
Editor. This renders the file in your default Web browser or any other application
that has been associated with XML files. On UNIX, if you have not set up your
browser configuration in SAS, you need to copy the two files to an environment
where you can bring up the define.xml in a Web browser. The style sheet
information in define1-0-0.xsl is not guaranteed to work for all browser types and
versions to produce the correct HTML, but it does work for Internet Explorer
version 6.0 and higher. In the browser, the define.xml contains a number of tables.
The first table should appear similar to the following table (only the first few rows
are provided here). Minor variations in appearance are possible and are not a
problem. Reviewing these rows is sufficient to confirm that the product is installed
and functioning properly.
5
The define.xml also contains tables for the following:
a) For each domain, a table lists its variables.
b) Computational Algorithms Section
c)
Controlled Terminology
Installation Qualification
Test 12: CRT-DDS Create Define.xml 27
The last table in define.xml contains controlled terminology. The last few items in
the file should be values for VSTESTCD, including the values BMI and WEIGHT.
6
End the SAS session.
Sign-Off
Test 12 – CRT-DDS Create Define.xml
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
28 Test 13: ODM 1.3.0 Create SAS ODM from XML
Chapter 1
Test 13: ODM 1.3.0 Create SAS ODM from XML
Introduction
This test reads a CDISC ODM 1.3.0 XML file and builds a SAS representation of the
metadata that is defined in the XML.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_ODM/Programs/create_sasodm_fromxml.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates data sets in the formats, metadata
and data subfolders under CST_ODM/derived and also creates a read_results data
set under CST_ODM/results.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the read_results data set under CST_ODM/results.
In the SAS Explorer, you can also view it as Read_results in the Results library.
a) Examine the message column to verify correct paths and process metadata
b) The column labeled Process status (named _cst_rc) should be 0 for all records.
c)
The data set should contain 49 records.
d) The last record should report that the ODM file was read successfully.
The folder CST_ODM/derived/metadata should contain two data sets:
source_tables and source_columns.
You can also view these data sets in the SAS Explorer in the library named
Srcmeta.
a) The data set source_tables should have 66 rows and 10 columns.
b) The data set source_columns should have 315 rows and 16 columns.
6
Review the folder CST_ODM/derived/data.
a) There should be 66 new SAS data sets.
b) The data set codelists should have 23 records and 5 columns.
7
Review the folder CST_ODM/derived/formats
a) There should be three new data sets and three new format catalogs.
b) The odmfmtcat_en data set should have 957 records and five columns.
8
End the current SAS session.
Installation Qualification
Sign-Off
Test 13 – ODM1.3.0 Create SAS ODM From XML
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 13: ODM 1.3.0 Create SAS ODM from XML 29
30 Test 14: ODM 1.3.0 Validate SAS ODM
Chapter 1
Test 14: ODM 1.3.0 Validate SAS ODM
Introduction
This test validates a SAS representation of the metadata that is defined in the CDISC
ODM 1.3.0 XML file.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_ODM/Programs/validate_odm_data.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates a validation_results data set and a
validation_metrics data set under CST_ODM/results. This code can fill up the
LOG window if running interactively. If so, save the output of the log to a file
when prompted to do so.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the validation_results data set under CST_ODM/results.
In the SAS Explorer, you can also view it as Validation_results in the Results
library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The data set should contain 343 records.
c)
6
There should be 2 records with resultflag=1 and resultseverity="Error". Both
of these records have checkid="ODM0110" and resultid="ODM0110". The
errors messages start with "The foreign key OID does not have a
corresponding value in the target data set".
Review the data set validation_metrics under CST_ODM/results.
In the SAS Explorer, you can also view it as Validation_metrics in the Results
library.
a) The data set should contain 604 records.
b) The last record should report that there were two records with "Content
errors, warnings and notes".
7
End the current SAS session.
Installation Qualification
Sign-Off
Test 14 – ODM1.3.0 Validate SAS ODM
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 14: ODM 1.3.0 Validate SAS ODM 31
32 Test 15: ODM 1.3.0 Create ODM XML from SAS ODM
Chapter 1
Test 15: ODM 1.3.0 Create ODM XML from SAS ODM
Introduction
This test creates a CDISC ODM 1.3.0 XML file from the SAS representation of the
metadata.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_ODM/Programs/create_odmxml.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates an XML file odm_sample_out.xml in
the CST_ODM/sourcexml folder and also creates a write_results data set under
CST_ODM/results.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set write_results under CST_ODM/results.
In the SAS Explorer, you can also view it as Write_results in the Results library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The column named resultflag should be 0 for all records.
c)
The data set should contain 65 records.
d) There should be a record, with scrdata="ODM_WRITE", reporting that the
ODM file was created.
e) The last record, with srcdata="ODM_XMLVALIDATE", should report that no
errors were found in the ODM file.
6
The folder CST_ODM/sourcexml should contain a new XML file
odm_sample_out.xml, which should have the same size in Kb (317 Kb) as the XML
file odm_sample.xml in the same folder.
7
End the current SAS session.
Sign-Off
Test 15 – ODM1.3.0 Create ODM XML from SAS ODM
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Installation Qualification
Test 16: ODM 1.3.0 Find Unsupported Tags in ODM XML 33
Test 16: ODM 1.3.0 Find Unsupported Tags in ODM XML
Introduction
This test parses a CDISC ODM 1.3.0 XML file and finds elements and attributes that
SAS Clinical Standards Toolkit does not recognize by default. These might be, for
example, vendor or customer extensions or new tags implemented in a later version of
ODM.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_ODM/Programs/find_unsupported_tags.sas.
3
Select Run  Submit.
This code outputs to the SAS log and creates a readxmltags_results data set under
CST_ODM/results.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the data set readxmltags _results under CST_ODM/results.
In the SAS Explorer, you can also view it as Readxmltags_results in the Results
library.
a) The column labeled Process status (named _cst_rc) should be 0 for all records.
b) The column named resultflag should be 0 for 4 records, and should be 1 for all
other records.
c)
The data set should contain 24 records.
d) There should be four records (with checkid=” ODM0900”) where the column
named message indicates "Element found in XML file that is not present in
CDISC ODM Model".
6
End the current SAS session.
Sign-Off
Test 16 – ODM1.3.0 Find Unsupported Tags in ODM XML
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
34 Test 17: SDTM Controlled Terminology 201104
Chapter 1
Test 17: SDTM Controlled Terminology 201104
Introduction
This test verifies that controlled terminology package 201104 for SDTM is installed
and is available to SAS Clinical Standards Toolkit processes.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, enter the following SAS code.
%cstutil_setcstgroot;
libname fmts "&_cstGRoot./standards/cdisc-terminology-1.4/cdiscsdtm/201104/formats";
options fmtsearch=(fmts.cterms);
* Does expected format exist? *;
data _null_;
result = put('Albumin/Creatinine',$LBTEST.);
run;
data _null_;
set fmts.cterms (where=(codelist='LBTEST')) end=last;
attrib result format=$200.;
retain found 0 result '';
if _n_=1 then
result='Albumin/Creatinine';
if cdisc_submission_value=result then
do;
found=1;
result=catx(' ','Formatted value',result,'found');
put result=;
end;
if last and found=0 then put result= 'not found';
run;
If the format cannot be found (SAS log reports “ERROR 48-59: The format
$LBTEST was not found or could not be loaded.”) or if the specific test value is not
found, then there are problems with the installation and/or availability of the
controlled terminology package to the SAS Clinical Standards Toolkit processes.
You should see the following line at the end of the SAS log:
result=Formatted value Albumin/Creatinine found
3
End the current SAS session.
Installation Qualification
Sign-Off
Test 17 – SDTM Controlled Terminology 201104
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 17: SDTM Controlled Terminology 201104 35
36 Test 18: ADaM Controlled Terminology 201101
Chapter 1
Test 18: ADaM Controlled Terminology 201101
Introduction
This test verifies that controlled terminology package 201101 for ADaM has been
installed and is available to SAS Clinical Standards Toolkit processes.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, enter the following SAS code.
%cstutil_setcstgroot;
libname fmts "&_cstGRoot./standards/cdisc-terminology-1.4/cdiscadam/201101/formats";
options fmtsearch=(fmts.cterms);
* Does expected format exist? *;
data _null_;
result = put('DERIVED',$PARAMTYP.);
run;
data _null_;
set fmts.cterms (where=(codelist='PARAMTYP')) end=last;
attrib result format=$200.;
retain found 0 result '';
if _n_=1 then
result='DERIVED';
if cdisc_submission_value=result then
do;
found=1;
result=catx(' ','Formatted value',result,'found');
put result=;
end;
if last and found=0 then put result= 'not found';
run;
If the format cannot be found (SAS log reports “ERROR 48-59: The format
$PARAMTYP was not found or could not be loaded.”) or if the specific test value is
not found, then there are problems with the installation and/or availability of the
controlled terminology package to the SAS Clinical Standards Toolkit processes.
You should see the following line at the end of the SAS log:
result=Formatted value DERIVED found
3
End the current SAS session.
Installation Qualification
Sign-Off
Test 18 – ADaM Controlled Terminology 201101
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 18: ADaM Controlled Terminology 201101 37
38 Test 19: CDASH Controlled Terminology 201104
Chapter 1
Test 19: CDASH Controlled Terminology 201104
Introduction
This test verifies that controlled terminology package 201104 for CDASH has been
installed and is available to SAS Clinical Standards Toolkit processes.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, enter the following SAS code.
%cstutil_setcstgroot;
libname fmts "&_cstGRoot./standards/cdisc-terminology-1.4/cdisccdash/201104/formats";
options fmtsearch=(fmts.cterms);
* Does expected format exist? *;
data _null_;
result = put('AEROSOL',$CMDOSFRM.);
run;
data _null_;
set fmts.cterms (where=(codelist='CMDOSFRM')) end=last;
attrib result format=$200.;
retain found 0 result '';
if _n_=1 then
result='AEROSOL';
if cdisc_submission_value=result then
do;
found=1;
result=catx(' ','Formatted value',result,'found');
put result=;
end;
if last and found=0 then put result= 'not found';
run;
If the format cannot be found (SAS log reports “ERROR 48-59: The format
$CMDOSFRM was not found or could not be loaded.”) or if the specific test value
is not found, then there are problems with the installation and/or availability of
the controlled terminology package to the SAS Clinical Standards Toolkit
processes. You should see the following line at the end of the SAS log:
result=Formatted value AEROSOL found
3
End the current SAS session.
Installation Qualification
Sign-Off
Test 19 – CDASH Controlled Terminology 201104
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Test 19: CDASH Controlled Terminology 201104 39
40 Test 20:ADaM 2.1 Validation
Chapter 1
Test 20: ADaM 2.1 Validation
Introduction
This test runs the sample program that ships as part of the ADaM 2.1 standard. If
this program runs successfully and produces the expected results, then the ADaM 2.1
standard is correctly installed and functioning properly.
Steps
1
Submit the ADaM 2.1 validation sample program
CST_ADAM/programs/validate_data.sas.
It outputs to the SAS Log and generate two SAS data sets: Validation_results and
Validation_metrics. These data sets can be found in the Results library within the
SAS Explorer window.
2
Review the log to see if there are any errors or warnings; there should not be any.
Test 20:ADaM 2.1 Validation 41
Installation Qualification
3
Review the data set Validation_results for errors.
It should be consistent with the following table. Values that refer to temporary
folders/files, user IDs, or PROCESS DATE: vary (in bold below). It contains
additional columns, but checking these is sufficient.
Row
Result
Identifier
Validation
Check
Identifier
Unique
Invocation
of resultid
Seq #
within
resultseq
Source data
1 CST0108
1
1 CST_SETPROPERTIES
2 CST0102
1
1 CST_CREATEDS
3 CST0200
1
1 CSTUTIL_PROCESSSETUP
4 CST0108
1
1 CST_SETPROPERTIES
5 CST0108
1
1 CST_SETPROPERTIES
6 CST0200
1
1 ADAM_VALIDATE
7 CST0200
1
2 ADAM_VALIDATE
8 CST0200
1
3 ADAM_VALIDATE
9 CST0200
1
4 ADAM_VALIDATE
10 CST0200
1
5 ADAM_VALIDATE
11 CST0200
1
6 ADAM_VALIDATE
12 CST0200
1
7 ADAM_VALIDATE
13 CST0200
1
8 ADAM_VALIDATE
14 CST0200
1
9 ADAM_VALIDATE
15 CST0200
1
10 ADAM_VALIDATE
16 CST0100
ADAM0001
1
1 SRCDATA.ADSL
17 CST0100
ADAM0002
1
1 WORK._CSTCOLUMNMETADATA
18 CST0025
ADAM0003
1
1 WORK._CSTCOLUMNMETADATA
19 CST0025
ADAM0007
1
1 WORK._CSTCOLUMNMETADATA
20-38 Many additional similar rows are reported.
N = 38
Additional columns for rows 1–19 are as follows:
Row
Resolved message text from message file
Result
Severity
resultflag
_cst_rc
1 The properties were processed from the PATH
c:/cstGlobalLibrary/standards/cst-framework1.4/programs/initialize.properties
Info
0
0
2 work.validation_sasrefs was created as requested
Info
0
0
3 Process setup is using this SASReferences:
C:\DOCUME~1\userid\LOCALS~1\Temp\SAS
Temporary Files\_TD4812/validation_sasrefs
Info
0
0
4 The properties were processed from the PATH
c:/cstGlobalLibrary/standards/cdisc-adam-2.11.4/programs/initialize.properties
Info
0
0
Info
5 The properties were processed from the PATH
!sasroot/../../SASClinicalStandardsToolkitADaM21/1.4/sam
ple/cdisc-adam2.1/sascstdemodata/programs/validation.properties
0
0
42 Test 20:ADaM 2.1 Validation
Row
Chapter 1
Resolved message text from message file
Result
Severity
resultflag
_cst_rc
6 PROCESS STANDARD: CDISC-ADAM
Info
0
0
7 PROCESS STANDARDVERSION: 2.1
Info
0
0
8 PROCESS DRIVER: ADAM_VALIDATE
Info
0
0
9 PROCESS DATE: 2011-08-10T14:32:59
Info
0
0
10 PROCESS TYPE: VALIDATION
Info
0
0
11 PROCESS SASREFERENCES:
C:\DOCUME~1\userid\LOCALS~1\Temp\SAS
Temporary Files\_TD4812/validation_sasrefs.sas7bdat
Info
0
0
Info
12 PROCESS STUDYROOTPATH:
!sasroot/../../SASClinicalStandardsToolkitADaM21/1.4/sam
ple/cdisc-adam-2.1/sascstdemodata
0
0
13 PROCESS GLOBALLIBRARY: c:/cstGlobalLibrary
Info
0
0
14 PROCESS CSTVERSION: 1.4
Info
0
0
15 PROCESS CONTROLLED TERMINOLOGY SOURCE:
c:/cstGlobalLibrary/standards/cdisc-terminology-1.4/cdiscadam/201101/formats/cterms (Controlled Terminology
released by NCI on 2011-01-07)
Info
0
0
16 No errors detected in SRCDATA.ADSL
Info
0
0
17 No errors detected in source data
Info
0
0
18 No errors detected in source data
Info
0
0
19 No errors detected in source data
Info
0
0
20–38 Many additional similar rows are reported.
N = 38
4
Close the SAS session.
Sign-Off
Test 20 – ADaM 2.1 Validation
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Installation Qualification
Test 21: ADaM 2.1 Report Process Results 43
Test 21: ADaM 2.1 Report Process Results
Introduction
This test produces a sample report based on ADaM 2.1 process results.
Steps
1
Start a new SAS session.
2
In the SAS Program Editor, select File  Open Program, and select
CST_ADAM/programs/cst_report.sas.
3
Select Run  Submit.
This code outputs to the SAS log and generates a PDF file. No result data set is
created.
4
Review the log to see if there are any errors or warnings; there should not be any.
5
Review the PDF file; it is named cstreport.pdf and is located in the folder
CST_ADAM/results.
As noted in the Notes and Assumptions section, this PDF file should automatically
be displayed on Microsoft Windows. If you are on UNIX, refer back to this section
for instructions for approaches for viewing the PDF.
a) All five of the following report panels should be generated.
i.
ii.
Report Summary
Process Inputs/Outputs
iii.
Process Metrics
iv.
General Process Reporting
v.
Process Results (will contain many bookmarks)
b) All titles, paths, dates, etc. should appear correct. Compare to image below.
6
Close the SAS session.
44 Test 21: ADaM 2.1 Report Process Results
Chapter 1
Sign-Off
Test 21 – ADaM 2.1 Report Process Results
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Installation Qualification
Final Sign-Off 45
Final Sign-Off
In the table below, indicate your final assessment about whether or not SAS Clinical
Standards Toolkit 1.4 is installed correctly and is functioning properly.
If any of the IQOQ tests listed above did not pass, then the final IQOQ assessment
must not be passed, unless you have provided sufficient documentation to explain
otherwise.
Final assessment of all testing.
Signature
Date Test Was Executed
Did the IQOQ pass? (Yes or No)
Comments
46 Final Sign-Off
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