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.
CDISC
Referenced in API Evangelist papers
This standard shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this standard in the context of a real sector.
The State of Biotechnology APIs
The most-named domain standard in biotechnology after FHIR, at 8 of 999 companies — and like FHIR it travels on a regulatory mandate, since the FDA will not accept a submission without it.
