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:
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 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 http://ftp.sas.com/techsup/download/hotfix/12clintlkt.html.
The installation instructions and Installation Qualification documentation are included with the download.
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).
These papers introduce you to SAS Clinical Standards Toolkit and can help you understand how it functions.
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.