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CDISC Support

Base SAS

SAS® Clinical Standards Toolkit


The SAS® Clinical Standards Toolkit provides support of multiple CDISC standards, including SDTM (3.1.1, 3.1.2, 3.1.3, and 3.2), CRT-DDS (reading and creating define 1.0 xml files), Define-XML 2.0 (reading and creating define 2.0 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

The set of new functionality provided in the recent release of SAS Clinical Standards Toolkit 1.6 includes:

Ordering the Toolkit

SAS Clinical Standards Toolkit 1.6 is supported with SAS 9.3 and SAS 9.4 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.

Toolkit Version Availability
1.6 Available with SAS 9.4 (TS1M1) or later
Available with SAS 9.3 (TS1M2) or later
1.5 Available with SAS 9.3 (TS1M2) or later
1.4 Available with SAS 9.3 for releases prior to TS1M2
1.3 Available only on SAS 9.2
1.2 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

Toolkit Documentation

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


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

Version 1.6

Version 1.5

Version 1.4 and Earlier

Preproduction Functionality

Support for Dataset-XML v1.0 is available as a preproduction package that contains SAS macros, XML schema files, sample data, and sample programs to support the following functionality:

These macros are standalone and do not require SAS Clinical Standards Toolkit.

Download the preproduction package, datasetxml.zip, and the documentation, SAS Macros to support Dataset-XML v1.0.0 (.pdf). ZIP and PDF updated 28 October 2014.

Disclaimer: THIS PRELIMINARY DOCUMENTATION AND CODE ARE PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. The Institute shall not be liable whatsoever for any damages arising out of the use of this documentation or code, including any direct, indirect, or consequential damages. The Institute reserves the right to alter or abandon use of this documentation at any time. In addition, the Institute will provide no support for the materials contained herein.

What's Next?

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 in Health Care Related Fields and Clinical Trials forum to help guide development.

The preproduction Migration Tools, associated with the SAS Clinical Standards Toolkit 1.6 Migration Guide (see links above) will be formally added to SAS Clinical Standards Toolkit 1.7. Other anticipated SAS Clinical Standards Toolkit 1.7 changes are expected to include:

If you have other suggestions for product updates, contact your SAS representative or via the discussion forum described below.

Discussion Forum

To participate in a discussion about SAS and the clinical trials process, see the SAS in Health Care Related Fields and Clinical Trials forum.