Clinical Data Interchange Standards Consortium

Founded in 1997, CDISC develops open, global standards for collecting, structuring and submitting clinical research data. Its Study Data Tabulation Model and Analysis Data Model are mandatory for new drug applications to the US FDA and Japan's PMDA and accepted by China's NMPA, and its Controlled Terminology, CDASH data collection standards and Therapeutic Area User Guides (including for breast, prostate and lung cancer and for oncology endpoints such as RECIST) make trial data comparable across sponsors. CDISC standards underpin data sharing platforms such as Vivli and Project Data Sphere and the pooled analyses that regulators and academics run on legacy oncology trials. It works with HL7 on mapping trial standards to FHIR healthcare data.