Testing CDISC data with the new SAS Clinical Standards Toolkit
Global data standards are continually gaining more relevance in clinical research – not only in the electronic submission procedure for the approval of medication, but also for the in-house processing and the exchange of clinical data between companies. The platform-independent software standards for clinical data and metadata, which have specially been developed for this purpose by the CDISC organisation, are increasingly asserting themselves in the pharmaceutical industry and the regulatory authorities.
Companies that are occupied with the creation, processing and distribution of such data are confronted with several challenges: Data of varying origin and structure must be converted into the appropriate data model and accurately described in standard metadata documents. The original data must not suffer any changes in semantics because of the conversion; therefore the stated standards must as a rule is accompanied by company or trial specifications.
Due to the diverse content related decisions during the assignment of data elements, the conversion of so-called legacy data into a CDISC data model is not easy to automate. However, in order that the data management remains controllable, software tools are required to automatically test all that can be automated, namely whether the data structure conforms to the specification. Belonging to the conducted tests would be checks, for example, for the structure of the tables, for the attributes of variables, for relationships between records in varying tables, and for the characteristics of variables. The validation of CDISC data becomes substantially simplified through this approach.
With the SAS Clinical Standards Toolkit, SAS Institute presented just such a tool in mid 2009. The Clinical Standards Toolkit is a bundle of macros available for SAS 9.1.3 and SAS 9.2. It functions solely on the basis of SAS/Base and SAS/Macro, and will be ceded on request for use free of charge within the scope of a SAS/Base license.
The Clinical Standards Toolkit provides a framework for the validation and conversion of data. Currently included is the validation of files according to the SDTM model (including 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, other standards or new versions of existing standards can be “retrofitted”. As a result, it is also possible to incorporate additional proprietary checks into this framework.
This course provides skills and knowledge for the installation, configuration and application of the SAS Clinical Standards Toolkit. Participants shall be placed in a position to integrate this tool into their organisations environment in such a way, that the quality and the speed of CDISC data model transformations will be enhanced.
The participants should have experience with data management in clinical research and possess background knowledge related to the CDISC standard and its application, especially SDTM. The SAS programming language (BASE and Macro) is familiar through lengthy practical application.
Data managers and SAS programmers involved in clinical research in pharmaceutical companies and service providers.
Base SAS Software, SAS Clinical Standards Toolkit (SAS Version 9.2).
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