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Introduction to the SAS Clinical Standards Toolkit

The SAS® Clinical Standards Toolkit is a framework for the validation of CDISC data, especially SDTM, and the generation of define.xml. It has been launched by SAS Institute as an add-on to SAS Base at no additional charge in mid 2009. Currently it includes the validation of files according to the SDTM model (including most of the published WebSDM and Janus checks), as well as the creation of metadata according to CRT-DDS for the submission. Since all the metadata and rules are stored in SAS tables, modified standards or new versions of existing standards can be integrated by the user. Also, SAS Institute has announced the integration of further standards and standard versions.

This tutorial gives an introduction to the SAS Clinical Standards Toolkit. Programming examples will be provided along with some background about the modular structure of the toolkit. Participants will be enabled to assess usability for their application.

Background

Pharmaceutical companies increasingly apply industry-wide clinical data standards a) to meet the requirements of the US Food and Drug Administration (FDA) when submitting New Drug Applications (NDA) electronically (eCTD submission) and b) to ease the data exchange with partners and CROs. A global standards organization is the Clinical Data Interchange Standards Consortium (CDISC) that published the Study Data Tabulation Model (SDTM) of human clinical study data tabulations for submission to regulatory authorities. The FDA stores CDISC SDTM data plus their accompanying metadata in a so-called Janus data warehouse. The metadata of the content and structure of the submitted clinical data are described in a machine readable XML document named Case Report Tabulation Data Definition Specification (CRT-DDS or define.xml). The XML schema for the define document is also based on an extension of another standard, the CDISC Operational Data Model (ODM).

Before loading clinical data and the define.xml into the Janus warehouse, several validation checks are performed deploying the WebSDMTM software. Conformance of the submission deliverables (data and metadata) to SDTM and CRT-DDS is verified. After successfully loading the files into Janus, additional validation checks are employed within the Janus reviewer tools (Janus checks).

For the pharmaceutical industry it is now a necessity to generate and validate the FDA submission deliverables. A SAS macro based framework, the SAS Clinical Standards Toolkit (CST), alleviates the process of becoming compliant with regulatory standards.

The SAS Clinical Standards Toolkit 1.2 initially provides a set of standards and functionality aimed to generate the define.xml (from study metadata) and to perform validation checks against implemented standards. Currently the SAS Clinical Standards Toolkit 1.2 supports the CDISC-SDTM 3.1.1, CDISC-CRTDDS 1.0 and CDISC-Terminology-200810 standards and has implemented most WebSDM 2.6, the Janus and several SAS-developed checks to back up the SDTM compliance. Support for SDTM 3.1.2 and terminology 201003 is available as a preproduction update and it is announced that it will become productive in the end of 2010.

Exceeding these standards, the toolkit has also the capability to be extensible and configurable to add new validation checks, new versions of standards, custom standards and upcoming standards. To manage that, the modular designed CST is built as a framework plus various pluggable standard modules that contribute to the centrally managed process runs. By providing an extensive process library of utility programs and data the toolkit enables the user to build robust processes to accomplish extensions to the above listed tasks and standards.


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