The SAS® Clinical Standards Toolkit provides support of multiple CDISC standards,
including SDTM (3.1.1, 3.1.2 and 3.1.3), CRT-DDS (reading and creating define.xml files), ODM (reading and creating 1.3.0 and 1.3.1 xml files), ADaM 2.1, and SEND 3.0. 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 continued releases planned in its product roadmap.
The set of new functionality provided in the recent release of SAS Clinical Standards Toolkit 1.5 includes:
Introduction of the SAS Clinical Standards Toolkit Sample Library
Introduction of a set of tools to validate Toolkit metadata
CDISC-SDTM updates include:
Full support of SDTM 3.1.3
Rewrite of the SDTM check utility macro sdtmcheckutil_recordlookup to optimize performance
CDISC-ODM updates include:
Full support of ODM 1.3.1
Support for the extraction of ODM Clinical and Reference data into SAS data sets
CRT-DDS 1.0.0 (define.xml) updates:
Create define.xml for ADaM
Define value level metadata (SDTM)
Define parameter value level metadata (ADaM)
Define document metadata for annotated CRFs and supplemental documents (SDTM)
Create define.pdf for SDTM and ADaM
CDISC-ADaM 2.1 updates:
Support for ADAE Version 1.0
An sample implementation of ADTTE Version 1.0
New validation checks in support of ADAE and ADTTE
An initial implementation of the CDISC SEND 3.0 standard
Introduction of the new CT 1.0.0 standard:
Support for import of NCI CDISC Controlled Terminology (CT) in the ODM XML format
Import samples for ADaM, CDASH, SDTM, SEND, Questionnaires, and the Clinical Data Element Glossary terminology
Additional columns have been added to all SASReferences and StandardSASReferences data sets
Full i18n multiple-byte character (UTF-8 and Shift JIS) support for clinical data
Updates to previously supplied Framework macros
New Framework macros, including new validation check and validation check utility macros
Ordering the Toolkit
SAS Clinical Standards Toolkit 1.5 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.
Available with SAS 9.3 (TS1M2) or later
Available with SAS 9.3 for releases prior to TS1M2
Available only on SAS 9.2
Available only on SAS 9.1.3 Windows. 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 1.6,
the following preproduction updates are under consideration:
Support for CDISC-SDTM 3.1.4 (including any available Therapeutic Area and Device domains)
Provide support for WebDAV and Oracle library and file access
Full implementation of CDISC Define-XML 2.0
Create define.xml for CDISC-SEND 3.0
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.
SAS Clinical Standards Toolkit 1.6 is expected to be released on SAS 9.4,
with consideration being given to release on SAS 9.3 as well.