CDISC Controlled Terminology Package 29 is ready for public review. The public review package consists of 13 documents:
- Laboratory Tests *
- Oncology *
- SEND *
- Units of Measure
- Protocol Entities
An Asterisk * indicates that changes to previously existing CDISC Submission Values are also included on the “Changes to Existing” tab in the document. Please review these changes.
CDISC Protocol Standard: A new superset of terminology is included with the P29 public review package to support the CDISC protocol standard, building on the work of several earlier, related efforts focused on the Protocol Representation Model and various clinical trial registries. This Protocol Entities terminology seeks to standardize commonly used concepts within a protocol while ensuring harmonization across existing CDISC terminology standards. In addition, a new approach to modeling the terms has been adopted, wherein a grouping of related terms, or 'attributes', are associated under a higher level 'entity'. Future terminology public review packages will contain additions to this initial set of Protocol Entities terminology.
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