Download the latest release of the SAS Clinical Standards Toolkit or PROC CDISC, for define.xml creation and SDTM validation.
http://support.sas.com/rnd/base/cdisc/cst/index.html - May 18, 2013 5:13:39 PM - Sep 30, 2010 2:25:37 PM
- 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)
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
- Windows x64
- Linux x64
- 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 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 Clinical Standards Toolkit version 1.2 for SAS 9.1.3 Windows customers (not supported on UNIX) is available for download at
These papers introduce you to SAS Clinical Standards Toolkit and can help you understand how it functions.
- 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)
- Using the SAS Clinical Standards Toolkit for define.xml creation (.pdf)
- Implementing, Managing, and Validating a Clinical Standard Using SAS Clinical Standards Toolkit 1.3 (.pdf)
- Define.xml - Tips and Techniques for Creating CRT-DDS (.pdf)
- The SAS Clinical Standards Toolkit (.pdf)
- Introduction to SAS Clinical Standards Toolkit (.pdf)
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.