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:
Introduction of a set of Metadata Management tools to add, update, and delete Toolkit metadata
Full support of CDISC-SDTM 3.2
Introduction of the new CDISC Define-XML 2.0 standard:
A complete definition of the metadata model for CDISC Define-XML 2.0
Creation of a complete Define-XML 2.0 file based on study metadata, with study metadata examples from SDTM 3.1.2 and ADaM 2.1
Validation of a Define-XML 2.0 file against the XML schema definition, as published by CDISC
Import of a Define-XML 2.0 file into the SAS representation of the Define-XML 2.0 metadata model
For SAS 9.4, the SAS options CSTGLOBALLIB and CSTSAMPLELIB have been added pointing to the global standards library and the sample study library, respectively
The global macro variables _cstLRECL and _cstVersion have been added
New Framework macros, including cstcreatetablesfrommetadata and cstutilxmlvalidate, have been added
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.
Available with SAS 9.4 (TS1M1) or later Available with SAS 9.3 (TS1M2) or later
Available with SAS 9.3 (TS1M2) or later
Available with SAS 9.3 for releases prior to TS1M2
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
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:
Further enhancements for CDISC Define-XML 2.0
Implementation of the new CDISC Dataset-XML v1.0 specification
Support of CDISC-CDASH 1.1
A new SAS macro (cstutilmanagecolumnsize) to support reduction of column sizes to their maximum observed lengths
Discontinuation of support for CDISC-SDTM 3.1.1
Availability with SAS 9.4 only.
If you have other suggestions for product updates, contact your SAS representative or via the discussion forum described below.