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CDISC Support

Base SAS

SAS® Clinical Standards Toolkit

The SAS® Clinical Standards Toolkit 1.4 provides support of multiple CDISC standards, including SDTM (3.1.1 and 3.1.2), CRTDDS (reading and creating define.xml files), ODM (reading and creating 1.3.0 xml files) and ADaM 2.1. This tool is the platform used by SAS to support Health and Life Sciences industry data model standards. SAS Clinical Standards Toolkit is under active development with multiple releases planned in its product roadmap.

The recent release of SAS Clinical Standards Toolkit 1.4 provides full support of the CDISC-ODM 1.3.0 standard (reading and creating ODM xml files), the CDISC ADaM 2.1 standard (ADSL, Basic Data Structure and Analysis Results Metadata templates, as well as version 1.1 of the ADaM validation checks), and a CDISC Controlled Terminology package that includes the cumulative set of terminology as posted to the NCI FTP site as of April 2011. This set of terminology is sufficient to support the CDISC-SDTM 3.1.2 and ADaM 2.1 standards.

SAS Clinical Standards Toolkit 1.4 is supported with SAS 9.3 on the following operating systems:

• Windows 32
• Windows x64
• Linux x64
• Solaris SPARC
• Solaris AMD
• HP-UX Itanium

The toolkit is a separately orderable component that is available at no additional charge to currently licensed SAS customers. Contact your SAS Account Representative concerning availability.

Ordering the Toolkit

SAS 9.3

SAS Clinical Standards Toolkit version 1.4 for SAS 9.3 must be ordered through normal channels. Contact your SAS representative to have SAS Clinical Standards Toolkit added to your existing SAS license(s) for no additional fee.

SAS 9.2

SAS Clinical Standards Toolkit version 1.4 is not supported on SAS 9.2. SAS Clinical Standards Toolkit version 1.3 is currently available for SAS 9.2.

SAS 9.1.3

SAS Clinical Standards Toolkit version 1.2 for SAS 9.1.3 Windows customers (not supported on UNIX) is available for download at http://ftp.sas.com/techsup/download/hotfix/12clintlkt.html. The installation instructions and Installation Qualification documentation are included with the download.

Toolkit Documentation

Product documentation

for all production releases of SAS Clinical Standards Toolkit is available for download.

Tutorial files (.zip)

for Clinical Standards Toolkit 1.2 and 1.3. Unzip this archive into your c:\ directory. This ZIP file contains both the SAS 9.2 and SAS 9.1.3 files. If you extract the entire ZIP archive, you should get a copy of the Quick Start document along with two directories of tutorial files, cstQuickStart (for SAS 9.2) and cstQuickStart9.1.3 (for SAS 9.1.3).

Papers

These papers introduce you to SAS Clinical Standards Toolkit and can help you understand how it functions.

• The Implementation of Nested Value Level Metadata in the SAS Representation of the CRT-DDS v1.0.0 Model in the SAS Clinical Standards Toolkit (.pdf) by Lex Jansen, SAS Institute Inc., Cary, NC (SAS Institute white paper 2012)

• Using the SAS Clinical Standards Toolkit 1.4 for define.xml creation (.pdf) | and workshop materials (.zip) by Lex Jansen, SAS Institute Inc., Cary, NC (PharmaSUG 2012)

• How to Register a New Custom Standard within the Clinical Standards Toolkit (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (SAS Institute white paper 2011)

• Using the SAS Clinical Standards Toolkit to Work with the CDISC ODM Model (.pdf) by Lex Jansen, SAS Institute Inc., Cary, NC (PhUSE 2011)

• Implementing ADaM Using SAS Clinical Standards Toolkit 1.4 (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (PhUSE 2011)

• Implementing, Managing, and Validating a Clinical Standard Using SAS Clinical Standards Toolkit 1.3 (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (PhUSE 2010)

• Define.xml - Tips and Techniques for Creating CRT-DDS (.pdf) by Julie Maddox, SAS Institute Inc., Cary, NC, and Mark Lambrecht, SAS Institute Inc., Tervuren, Belgium (PhUSE 2010)

• The SAS Clinical Standards Toolkit (.pdf) by Dave Smith, SAS Institute Inc., Cary, NC (PhUSE 2009)

• Introduction to SAS Clinical Standards Toolkit (.pdf) by Andreas Mangold and Nicole Wachter, HMS Analytical Software GmbH, Heidelberg, Germany (PhUSE 2010)

Preproduction Updates

Periodically, preproduction functionality for the next release of SAS Clinical Standards Toolkit is made available here. Users are encouraged to download and use this functionality, and post feedback on the SAS and Clinical Trials community to help guide development. For SAS Clinical Standards Toolkit 1.5, the following preproduction updates are under consideration:

• Updates to the CDISC-ADaM model, such as ADAE and ADTTE
• Ability to create a define.xml file based on CDISC-ADaM content
• Additional CDISC-SDTM domains (such as those in support of medical devices and therapeutic areas) and changes captured in the SDTM Amendment 1
• Ability to create a printable (PDF) version of the define.xml file
• Support of value-level metadata for CDISC-CRTDDS
• Support of additional CDISC standards such as CDASH, SEND and PRM.

Check back with this site periodically for updates. Contact your SAS representative if any of these updates are of particular interest to you, or if you have other suggestions for product updates.