Clinical Data Interchange Standards Consortium Inc

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.

TECHNICAL - TO DATE, CDISC HAS DEVELOPED THERAPEUTIC AREA STANDARDS FOR OVER 40 DISEASES. IN 2021, CDISC RELEASED SIGNIFICANT NEW VERSIONS OF THE CDISC FOUNDATIONAL STANDARDS (SEND, CDASH, SDTM AND ADAM). CDISC ALSO RELEASED THE FOLLOWING THERAPEUTIC AREA USER GUIDES: TYPE 1 DIABETES, CROHN'S DISEASE, PANCREATIC CANCER, AND COVID-19. CDISC HAS ALSO STARTED THE CDISC OPEN RULES ENGINE INITIATIVE (CORE), TO HELP THE CLINICAL RESEARCH COMMUNITY WITH ELECTRONIC CONFORMANCE RULES.CDISC RELEASED SEVERAL UPDATES TO THE CDISC LIBRARY TO ADD NEW FEATURES AS WELL AS NEW VERSIONS OF THE STANDARDS. CDISC DEVELOPED THE INITIAL VERSIONS OF THE CORE RULE ENGINE AND RULE EDITOR SOFTWARE WORKING TOWARDS AN MINIMUM VIALBLE PRODUCT RELEASE. CDISC BEGAN WORK ON THE DIGITAL DATA FLOW PROJECT TO CREATE A STANDARD REFERENCE ARCHITECTURE FOR A STUDY DESIGN REPOSITORY.CDISC CREATED THE CDISC OPEN-SOURCE ALLIANCE (COSA) TO PROMOTE, SUPPORT, AND SOMETIMES SPONSOR OPEN-SOURCE SOFTWARE FOCUSED ON IMPLEMENTING OR DEVELOPING THE CDISC STANDARDS TO DRIVE INNOVATION.

EDUCATION - IN 2021, CDISC EDUCATION CONTINUED TO EXPAND ITS ONLINE PROGRAM WITH OVER 120 VIRTUAL TRAINING EVENTS LED THROUGHOUT THE YEAR - ALMOST TRIPLING THE NUMBER OF EVENTS FROM THE PREVIOUS YEAR. THE EDUCATION TEAM COLLABORATED TO PRODUCE THE WORLD'S FIRST CDISC STANDARDS CERTIFICATION WITH THE RELEASE OF THE SDTM TABULATE CERTIFICATION PROGRAM. CDISC EDUCATION ALSO WORKED WITH THE VOLUNTEER COMMUNITY TO PRODUCE THREE NEW THERAPEUTIC AREA ONLINE TRAININGS IN 2021.

EVENTS - CDISC HOSTED FOUR VIRTUAL CONFERENCES IN 2021. THESE CONFERENCES WERE "INTERCHANGES," INDIVIDUALLY FOCUSED ON EUROPE, JAPAN, CHINA, AND UNITED STATES MARKETS. THE EVENTS PROMOTED RECENT ADVANCEMENTS BY CDISC STANDARDS TEAMS, CDISC MEMBERS AND INDEPENDENT DEVELOPERS. ATTENDEES CAME FROM VARIOUS ORGANIZATIONS IN PHARMACEUTICAL, CRO, TECHNOLOGY, ACADEMIC AND BIOTECH SECTORS.

PARTNERSHIPS & COLLABORATION - CDISC HAS OVER 530 ACTIVE MEMBERORGANIZATIONS. OUR MEMBERS' SUPPORT ENSURES THAT THE CDISC STANDARDSREMAIN OPEN AND FREE. MEMBERSHIP DUES ALLOW CDISC TO ACCOMPLISH THEPROGRAM SERVICES MENTIONED ABOVE. CDISC ALSO WORKS CLOSELY WITHREGULATORS AROUND THE WORLD TO ENSURE THAT CDISC STANDARDS FACILITATETHE E-SUBMISSION REVIEW PROCESS AND SUPPORT THE APPROVAL OF NEW CURESAND TREATMENTS.