Data standards are now required for many submissions to the United States Food and Drug Administration (FDA). The required standard for submission of clinical data is the Clinical Data Interchange Standards Consortium (CDISC) Submission Data Tabulation Model (SDTM). Currently, 45 business rules and 115 associated validation rules exist for SDTM data. However, such rules have not yet been developed for therapeutic area data standards developed under the last reauthorization of the Prescription Drug User Fee Act (PDUFA V). The objective of this effort was to develop data validation rules for new therapeutic area data standards in four mental health domains, assess the metadata required to associate such rules with standard data elements, and assess the level of data validation possible for therapeutic area data elements.
Keywords: CDISC SDTM; data standards; regulatory submissions; therapeutic area standards; validation rules.