Abstract
This article proposes a comprehensive set of data standards to address the submission of clinical data based on the work of the Clinical Data Interchange Standards Consortium (CDISC). The present components of the CDISC submission standards are described and related to Food and Drug Administration guidelines on submission as expressed in the 1999 guidance documents on regulatory submissions and the 2005 guidance on the electronic Common Technical Document (eCTD). The relative roles of the CDISC Study Data Tabulation Model (SDTM); the Case Report Tabulation Data Description Specification (defme.xml), which is based on the CDISC Operational Data Model (ODM); and the Analysis Dataset Models (ADaM) in meeting submission data requirements are next described. Finally, this article discusses implementation alternatives for sponsors, future directions, and the potential benefit of current projects to improve the submission process.
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