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• The documents have been posted to the CTSU Collaboration Portal as a workaround.

Can an LPO curate CDISC-harmonized CDEs using a CDISC/CDASH compliant caDSR CDE Short Name and Data Element Concept (DEC), with an enumerated Values Domain (VD) that might not be CDISC/CDASH compliant due to PVs/PVMs being very specific for certain type of disease/diagnosis groups? 

• An LPO has three options regarding VDs if/when curating new CDISC-harmonized CDEs: 

  1. Appropriately reuse an existing VD that was created per published CT as part of the NCI CDISC Imp (add PVs/PVMs if an extensible codelist per CDISC);
  2. Curate a new VD specifying COG-identified PVs/PVMs, if a sponsor-defined codelist is allowable per CDISC;
  3. Reuse an existing non CDISC-harmonized VD & map on the backend.