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SAS® Clinical Standards Toolkit


The SAS® Clinical Standards Toolkit provides support of multiple CDISC standards, including SDTM (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, including analysis results metadata), Dataset-XML (creating Dataset-XML files from SAS data sets and creating SAS data sets from Dataset-XML files), ODM (reading and creating 1.3.0 and 1.3.1 XML files), ADaM 2.1, CDASH 1.1, SEND 3.0, and validating XML files against an XML schema file. 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 1.7 includes:

SAS Clinical Standards Toolkit 1.7.2 is a hot fix (available for download) that adds support for the CDISC Analysis Results Metadata specification version 1.0 for Define-XML version 2.0, and also adds the December 2015 snapshot of CDISC NCI controlled terminology for ADaM. This hot fix also fixes bugs and adds several metadata attributes to the source metadata data sets that were previously hard-coded.

Ordering the Toolkit

SAS Clinical Standards Toolkit 1.7 and 1.7.2 are supported with SAS 9.4 on the following operating environments:

The toolkit is a separately orderable component that is available at no additional charge to currently licensed SAS customers. Contact your SAS Account Representative to request the toolkit to be added to your Base SAS order.

Toolkit Version Availability
1.7.2 Available with SAS 9.4 (TS1M3) or later with hot fix
1.7 Available with SAS 9.4 (TS1M2) or later
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 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.

The migration guide includes information about migration tools that are available in


These papers provide more detail about the SAS Clinical Standards Toolkit and can help you understand how it functions.

Discussion Forum

To participate in a discussion about SAS and the clinical trials process, see the Health Care and Pharma forum.