Specifications

Once the initial mapping of the raw data variables to the SDTM domain is completed, specifications for each SDTM domain are developed.  Each SDTM domain includes the required and expected variables as well as any relevant permissible or relationship variables.  Instructions for mapping or conversion of raw data to standard SDTM terminology will be documented within the specifications.  Specifications for supplementary domains, SUPP--, are produced as needed.