Optimizing SDTM Specification Development with Auto-Population

PhUSE-CSS 2018 -- On many studies, the development of SDTM specifications can be optimized using SAS macros. During the creation of the SDTM data, the author manually identifies mapping rules and a certain level of metadata, for which CDISC review software or sponsor created specs can be used. When the raw data has several levels of SDTM compliance, SAS macros can be utilized to compare raw data values to the CDISC Controlled Terminology database. Macros can also check the conformance of raw values and metadata with SDTM standards. This enables the auto-population of mapping rules into the specification, significantly reducing the manual work time. Furthermore, these benefits can be achieved by using a single SAS macro that leverages MS Excel such that the spec authors never need to open raw data sets or terminology files.