SAS® Clinical Data Standards
Toolkit 1.3
Installation Qualification
The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2010.
®
SAS
Clinical Data Standards Toolkit 1.3: Installation Qualification. Cary, NC: SAS
Institute Inc.
®
SAS
Clinical Data Standards Toolkit 1.3: Installation Qualification
Copyright © 2010, SAS Institute Inc., Cary, NC, USA
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1st electronic book, November 2010
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iii
Contents
Chapter 1 Installation Qualification 1
Purpose 1
Notes and Assumptions 2
Test 1 – SAS Hot Fix for ISO 8601 Informats Has Been Installed 3
Steps 3
Sign-off 3
Test 2 –SDTM 3.1.1 Validation 3
Steps 3
Sign-off 5
Test 3 – SDTM 3.1.1 Report Process Results 5
Steps 6
Sign-off 6
Test 4 – SDTM 3.1.2 Validation 6
Steps 6
Sign-off 7
Test 5 – SDTM 3.1.2 Build Source Data 7
Steps 7
Sign-off 8
Test 6 – SDTM 3.1.2 Build Source Metadata 8
Steps 8
Sign-off 9
Test 7 – SDTM 3.1.2 Build SAS Formats 9
Steps 9
Sign-off 10
Test 8 – SDTM 3.1.2 Report Check Metadata 10
Steps 10
Sign-off 11
Test 9 – CRT-DDS Create 11
Steps 11
Sign-off 11
Test 10 – CRT-DDS Create Define.xml 11
Steps 12
Sign-off 13
Test 11 – ODM 1.3.0 Create SAS ODM from XML 13
Steps 13
Sign-off 14
Test 12 – Controlled Terminology 200810 14
iv Contents Chapter Error! No text of specified style in document.
Steps 14
Sign-off 15
Test 13 – Controlled Terminology 201003 15
Steps 15
Sign-off 16
Final Sign-off 16
1
CHAPTER CHAPTER
1
Installation Qualification
Installation Qualification 1
Purpose 1
Notes and Assumptions 2
Test 1 – SAS Hot Fix for ISO 8601 Informats Has Been Installed 3
Steps 3
Sign-off 3
Test 2 –SDTM 3.1.1 Validation 3
Steps 3
Sign-off 5
Test 3 – SDTM 3.1.1 Report Process Results 5
Steps 6
Sign-off 6
Test 4 – SDTM 3.1.2 Validation 6
Steps 6
Sign-off 7
Test 5 – SDTM 3.1.2 Build Source Data 7
Steps 7
Sign-off 8
Test 6 – SDTM 3.1.2 Build Source Metadata 8
Steps 8
Sign-off 9
Test 7 – SDTM 3.1.2 Build SAS Formats 9
Steps 9
Sign-off 10
Test 8 – SDTM 3.1.2 Report Check Metadata 10
Steps 10
Sign-off 11
Test 9 – CRT-DDS Create 11
Steps 11
Sign-off 11
Test 10 – CRT-DDS Create Define.xml 11
Steps 12
Sign-off 13
Test 11 – ODM 1.3.0 Create SAS ODM from XML 13
Steps 13
Sign-off 14
Test 12 – Controlled Terminology 200810 14
Steps 14
Sign-off 15
Test 13 – Controlled Terminology 201003 15
Steps 15
Sign-off 16
Final Sign-off 16
Purpose
This document explains how to verify that SAS Clinical Standards Toolkit 1.3 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 that is
presented.
2 Notes and Assumptions Chapter 1
Notes and Assumptions
The SAS System itself is assumed to be installed and functioning correctly. It is
not being tested.
SAS Clinical Standards Toolkit 1.3 has been installed.
The following code should be run to confirm that the post-installation step to
update the CDISC-SDTM 3.1.2 data set validation_master has been completed.
%cstutil_setcstgroot;
libname refcntl "&_cstGRoot./standards/cdisc-sdtm-3.1.2-
1.3/validation/control";
data _null_;
set refcntl.validation_master (where=(checkid='SDTM0602'));
if columnscope='' then
put "Post-installation step verified.";
else
do;
put "Warning: It appears that the post-installation step has not been
completed.";
put "Warning: Review the installation instructions to ensure Toolkit
functions properly.";
end;
run;
The person running these tests is familiar with running SAS programs. This
includes being able to submit SAS programs using the Program Editor, review the
SAS log, and review the contents of SAS data sets.
This document is used for both the UNIX and Windows environments. The
forward slash character ( / ) is used in file paths as the separator between path
components, which works on both OS environments. There is one table that
contains SAS output from a Windows environment that has a backslash in the file
paths.
Within this document
SASINSTALL is used to denote the SAS installation folder. This is the folder
into which all SAS products are installed.
SASROOT is used to denote the root folder for the SAS system installation.
The default value for SAS 9.1.3 is SASINSTALL/SAS 9.1.
The default value for SAS 9.2 is SASINSTALL/SASFoundation/9.2.
The tests refer to the following variables, which are defined relative to
SASINSTALL. When running the tests, you need to substitute the variable with
the following associated paths.
CST_SDTM_311
SASINSTALL/SASClinicalStandardsToolkitSDTM311/1.3/sample/cdisc-sdtm-
3.1.1/sascstdemodata
CST_SDTM_312
SASINSTALL/SASClinicalStandardsToolkitSDTM312/1.3/sample/cdisc-sdtm-
3.1.2/sascstdemodata
CST_ODM
SASINSTALL/SASClinicalStandardsToolkitODM130/1.3/sample/cdisc-odm-
1.3.0
CST_CRTDDS
SASINSTALL/SASClinicalStandardsToolkitCRTDDS10/1.3/sample/cdisccrtdds-1.0
Installation Qualification / / Test 2 –SDTM 3.1.1 Validation 3
Test 1 – SAS Hot fix for ISO 8601 Informats has been installed
Signature
Date Test Was Executed
Did the test pass? (Yes or No)
Comments
Some of the tests (Tests 3 and 8) generate a PDF file. In Windows, when the PDF
is generated, a browser window should automatically appear that contains the
PDF for viewing. On UNIX, if you have not set up the SAS configuration variable
SAS.helpBrowser, then you get a dialog box that states “The requested
information could not be displayed because the connection to the remote browser
server failed.” Click OK to continue. You should either configure your UNIX SAS
environment to support a browser that can display PDF files or you need to copy
the PDF file to an environment where you can examine it.
Test 1 – SAS Hot Fix for ISO 8601 Informats Has Been Installed
This test only needs to be run if you are running SAS Version 9.1.3. If you have
downloaded SAS Clinical Data Standards Toolkit 1.3 from the SAS hot-fix site, then you
should verify that the SAS hot fix for the ISO 8601 SAS Informats has installed.
The identifier for this hot fix is E9BD36 and the URL for downloading the Windows
version is
other platforms, go to
and search on that page for E9BD36.
http://ftp.sas.com/techsup/download/hotfix/e9_win_sbcs.html#E9BD36
http://ftp.sas.com/techsup/download/hotfix/e9_sbcs_prod_list.html
. For
Steps
1 Verify that this hot fix has been installed following the standard SAS System hot
fix installation practices. Refer to the product documentation to identify which hot
fix is required. Additional information about hot fixes can be located at
http://ftp.sas.com/techsup/download/hotfix/hotfix.html
Sign-off
Test 2 –SDTM 3.1.1 Validation
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 Submit the SDTM 3.1.1 validation sample program
CST_SDTM_311/programs/validate_data.sas.
It outputs to the SAS log and generate two SAS data sets: Validation_results and
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