Sas Clinical Data Standards Toolkit User Manual

SAS® Clinical Data Standards
Toolkit 1.3

Installation Qualification

The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2010.

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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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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