 |
Page History
...
- Currently there are no tools that validate CDASH.
I can see that all of the CDASH fields have been curated. But, we will still have additional data collections items that we collect which are not part of CDASH for our trials– will we need to curate these as we do today?
LPOs should continue to curate new domains, new questions and new terminology from internal requests and from published standards version updates. Maintaining the standards implementation is crucially important. Otherwise, over time, the implementation will drift into chaos and become unusable. CBIIT can curate any additional data collection items they need – they will need to give us the Short Name/OID at the very least so we know what domain and variable they want to use, even if they are custom or non-standard variables. For Inclusion/Exclusion Criteria it is the same curation process we have right now. If additional non-standard CDEs are needed for Eligibility then the CBIIT team can curate those CDEs.
As none of the LPOs appear to be listed under research organizations on the CDISC Wiki, is there a plan to get them added or at least the NCTN?
- 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:
- 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);
- Curate a new VD specifying COG-identified PVs/PVMs, if a sponsor-defined codelist is allowable per CDISC;
- Reuse an existing non CDISC-harmonized VD & map on the backend.
