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These domains are related using RSLNKGRP, TULNKID, TUREFID, TRLNKID, TRLNKGRP, TRREFID and PRREFID. See Section 5 for more information on the relationships and an example RELREC dataset.

CDISC Biomedical Concepts in the CDISC Library (https://www.cdisc.org/cdisc-library).  The CDISC Biomedical Concepts (BCs) include a two-layered approach:

  • Conceptual/abstract layer that provides standards-agnostic, unambiguous semantic definition largely based on NCIt concepts.
  • Implementation layer based on valid CDISC dataset specializations that provide value level metadata definitions that facilitate metadata-driven automation.

SDTM dataset specializations have been defined for TU, TR and RS datasets.  The are retrievable via the CDISC Library API.

3.1 Assumptions for the Oncology Disease Response and Supporting Domains Model

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