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:
Introduction of a set of migration tools, previously offered as pre-production software, to help migrate from one version of the SAS Clinical Standards Toolkit to another.
Support for CDISC CDASH 1.1.
Enhanced support for creating an initial version of the six SAS source metadata data sets (source_study, source_tables, source_columns, source_codelists, source_values, and source_documents) that serve as input for creating a Define-XML 2.0 file.
Implementation of the CDISC Dataset-XML 1.0 data standard that can be used to transport CDISC SDTM, SEND, and ADaM data sets for submission of data to the FDA. See Sample 53447: SAS Macros to support Dataset-XML v1.0.0 on support.sas.com for information about a standalone version of the macros that support the CDISC-Dataset XML 1.0 standard.
Reduced and consolidated validation_master data sets for SDTM 3.1.2, 3.1.3, 3.2, and ADaM 2.1.
Updated support for CDISC NCI controlled terminology.
New framework macros have been added, including cstutilmanagecolumnsize, cstutilcomparemetadatasasdefine, cstutilsqlcolumndefinition, cstutilsqlgeneratetable, cstutilfindfixextdasciichars, cstutilregisterctsubtype, and cstutilxmlvalidate.
SAS Clinical Standards Toolkit 1.7.1 is a hot fix
(to be available for download here soon)
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.
Ordering the Toolkit
SAS Clinical Standards Toolkit 1.7 and 1.7.1 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.
Available with SAS 9.4 (TS1M3) or later with hot fix
Available with SAS 9.4 (TS1M2) or later
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