CDISC Migration
The Clinical Data Interchange Standards Consortium (CDISC) is a Standard-developing organization, standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and 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 International Organization for Standardization, ISO/European Committee for Standardization, CEN standard. History * Late 1997 – Started as a Volunteer group * Summer 1998 – Invited to form DIA SIAC * 1999 – SDS v1.0; ODM v0.8 * ...
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