Base SAS

CDISC Support

The Clinical Data Interchange Standards Consortium (CDISC) develops XML standards for the pharmaceutical industry. To support CDISC, SAS provides a new product named SAS Clinical Standards Toolkit as well as the SAS CDISC procedure.

SAS Clinical Standards Toolkit

The SAS Clinical Standards Toolkit is now available. The toolkit provides define.xml creation and SDTM validation, and eventually will support additional Health and Life Sciences industry standards. The toolkit is in active development with several additional releases planned, while PROC CDISC is planned for maintenance only - no new features. The toolkit is a separately orderable component that is available at no additional charge to currently licensed SAS customers.

For more information about the toolkit and how to order it, see SAS and the Clinical Data Interchange Standards Consortium (CDISC).

Toolkit Documentation

Documentation for the toolkit is available at SAS Clinical Standards Toolkit 1.2 User's Guide.

In addition, see the SAS Clinical Standards Toolkit 1.2 Quick Start for SDTM Validation for SAS 9.2 and SAS 9.1.3, which is a tutorial that provides a quick introduction to the toolkit. Follow the instructions in the document to unzip the contents of this ZIP file: Tutorial ZIP file.

PROC CDISC

The CDISC procedure in SAS supports the import, export, and processing of XML documents and content that are in CDISC-defined formats.

PROC CDISC Field Response Release

The field response release for PROC CDISC upgrades current functionality and adds support for models. It is updated more frequently than the production media version in order to support evolving CDISC standards for the pharmaceutical industry.

SAS 9.2 Customers - June 2009: 2.15.65

PROC CDISC is available for SAS 9.2 customers automatically with the Base SAS installation.

Update with the current field response release for SAS 9.2.

See the SAS CDISC Procedure: User's Guide (CDISC ODM 1.2 and CDISC SDTM 3.1).

SAS 9.1.3 Customers - June 2009: 2.15.65

PROC CDISC is available for SAS 9.1.3 customers automatically with the Base SAS installation.

Update with the current field response release for SAS 9.1.3.

See the SAS CDISC Procedure: User's Guide (CDISC ODM 1.2 and CDISC SDTM 3.1).

SAS 8.2 Customers - April 2007: 2.15.59

SAS 8.2 customers can obtain PROC CDISC from SAS 8.2 Hot Fix 82BC01.

Then update with current field response release for Release 8.2.

For documentation, see CDISC Procedure for the CDISC ODM 1.2 Format and CDISC Procedure for the CDISC SDTM 3.1 Format.

PROC CDISC Development Notes

Do not install the field response release module(s) over the existing image. Instead, install the modules in a different directory or folder as described in the installation instructions README file. Installing the modules over the existing image may invalidate the SAS Installation Qualification (IQ) tool checksum and cause that tool to report a failure. Checksums are updated only at hot fix or production media version release.
The field response release is available for a partial list of operating environments. For support under other operating environments, contact the XML integration team (e-mail xmlengine@sas.com) Additional operating environments are supported on a resources-available basis and only for operating environments that are supported by the Base SAS installation in SAS 9 or SAS 8.2.

PROC CDISC Documentation

For SAS 9.2 and SAS 9.1.3, see the SAS CDISC Procedure: User's Guide (CDISC ODM 1.2 and CDISC SDTM 3.1).
For SAS 8.2, see CDISC Procedure for the CDISC ODM 1.2 Format and CDISC Procedure for the CDISC SDTM 3.1 Format.
Example files

Your Turn

The developers, testers, and writers are very excited about the potential of these new capabilities. You can send electronic mail to xmlengine@sas.com with your comments.

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