Using Stata for handling CDISC datasets

The Clinical Data Interchange Standards Consortium (CDISC) is a globally relevant nonprofit organization that defines standards for handling data in clinical research. It produces a range of standards for clinical data at various stages of maturity. One of the most mature standards is the Study Data Tabulation Model, which provides a standardized yet flexible data structure for storing entire databases from clinical trials. A related standard is the Analysis Dataset Model, which defines datasets that can be used for analyzing data from clinical trials. I shall explain how the CDISC standards work, how Stata can simplify many of the routine tasks encountered in handling CDISC datasets, and the great efficiencies that can result from using datasets in a standardized structure.