Clinical Data Interchange Standards Consortium (CDISC)

Unlocking cures is their life’s work. At CDISC, they enable clinical research to work smarter by allowing data to speak the same language. CDISC is a 501(c)3 global, non-profit charitable organization that develops data standards to streamline clinical research and enable connections to healthcare, empowering the valuable information offered by patients participating in research studies around the world. CDISC standards are required for regulatory submissions to the US FDA and Japan PMDA, are endorsed by the China CFDA, and are requested for use by the European Innovative Medicines Initiative (IMI). CDISC is funded through the generous support of over 450 member organizations from pharmaceutical, biotech, clinical research organizations, regulatory agencies, academia, and healthcare, as well as through grants, authorized CDISC Education courses, events, and charitable contributions. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Benefits of implementing CDISC standards include: - Fostered efficiency - Enhanced innovation - Facilitated data sharing - Increased predictability - Complete traceability - Improved data quality - Reduced costs - Streamlined processes The CDISC Standards: 1. Clinical Data Acquisition Standards Harmonization (CDASH) 2. Operational Data Model (ODM) 3. Clinical Laboratory Data Model (LAB) 4. Study Data Tabulation Model (SDTM) 5. Standard for the Exchange of Non-Clinical Data (SEND) 6. Analysis Data Model (ADaM) 7. Protocol Representation Model (PRM) 8. Biomedical Research Integrated Domain Group Model (BRIDG) 9.Controlled Terminology CDISC Innovations: 1. Healthcare Link Initiative 2. Shared Health and Clinical Research Electronic Library (SHARE)