Date and Time
TUE, 17 MAY 2018, 10:00 AM - 11:30 AM Central Standard Time
Beginning-to-end CDISC standards requires establishing an interoperable protocol to begin the process of automated conduct of a clinical trial. A key feature of this interoperability is unambiguous semantics for concepts commonly presented within the protocol. The Protocol Entities terminology effort seeks to standardize commonly used protocol concepts, while ensuring harmonization across existing CDISC terminology standards.
Learn about a new approach to modeling the terms that have been adopted to support the many complex relationships inherent in protocol terminology, which may better support the adoption of a metadata-driven research environment. This novel approach groups related terms, or 'attributes', and associates them under a higher level 'entity'. This entity-attribute model will provide context for concept definitions and a framework on how to make semantic choices in pre-coordination versus post-coordination of protocol concepts. The protocol entities terminology team is also making use of the CDISC SHARE ecosystem in the development of these protocol concepts.
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- Melissa Cook, Protocol Entities Team Co-Lead, CDISC (Volunteer)
- Bill Lander, Director of Clinical Innovation and Digital Platforms, GSK
- Dr. Erin Muhlbradt, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
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