Supporting CDISC Standards in Base SAS Using the SAS Clinical Standards Toolkit

The use of regulatory standards aimed at clinical research data and metadata has become more commonplace over recent years. In the USA, the FDA is accepting standards from the Clinical Data Interchange Standards Consortium (CDISC) for submission of tabulation data (SDTM) and the main study metadata XML file (CRT-DDS). Work continues on new standards and updates to the existing ones. Previously, SAS users have not had to think so much about metadata and strict compliance to prescribed standards. The changing regulatory standards place an additional burden on SAS users, which translates to higher costs for companies. This paper will explain how the SAS Clinical Standards Toolkit supports users by providing a framework of macro-based functionality to help ensure that standards are applied to clinical data and metadata.