Abstract: The Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit standards development organization that creates consensus-based standards for clinical and translational research. Several of these standards are now required by regulators for electronic submissions of regulated clinical trials’ data and by government funding agencies. These standards are free and open, available for download on the CDISC Website as PDFs. While these documents are human readable, they are not amenable to ready use by electronic systems. CDISC launched the CDISC Shared Health And Research Electronic library (SHARE) to provide the standards metadata in machine-readable formats to facilitate the automated management and implementation of the standards. This paper describes how CDISC SHARE’s standards can facilitate collecting, aggregating and analyzing standardized data from early design to end analysis; and its role as a central resource providing information systems with metadata that drives process automation including study setup and data pipelining.

Learning Objective 1: After participating in this session, the learner should be better able to understand how the CDISC SHARE metadata repository represents clinical research data standards using a full-lifecycle model that promotes study setup and data pipelining automation.

Learning Objective 2 (Optional): After participating in this session, the learner should be better able to understand the different ways to access the machine-readable standards metadata provided by the CDISC SHARE metadata repository.

Learning Objective 3 (Optional): After participating in this session, the learner should better understand the new features and standards content currently under development for CDISC SHARE that seek to provide expanded opportunities for metadata-driven automation.


Sam Hume (Presenter)

Julie Evans, Samvit Solutions, LLC
Frederik Malfait, TransCelerate Biopharma
Julie Chason, CDISC
Julia Wold, CDISC
Wayne Kubick, HL7
Lauren Becnel, CDISC

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