Clinical Data Interchange Standards Consortium (CDISC)

CDISC publishes the data standards used to collect, tabulate and submit clinical trial data: CDASH for collection, SDTM for tabulation, ADaM for analysis datasets, SEND for nonclinical studies, ODM for operational data exchange, and Define-XML for dataset metadata. The FDA and Japan’s PMDA require SDTM and ADaM for regulatory submissions, which makes CDISC one of the few life-science standards carried by a mandate rather than by preference.