Clinical Data Interchange Standards Consortium

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The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and related areas of healthcare". The standards support medical research from protocol through analysis and reporting of results and have been shown to decrease resources needed by 60% overall and 70–90% in the start-up stages when they are implemented at the beginning of the research process.Since December 2016, CDISC standards are mandatory for submission to US FDA.

CDISC standards are harmonized through a model that is also a HL7 standard and is the process to becoming an ISO/CEN standard. Provided by Wikipedia