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General Questions


Who do I contact for CDISC Implementation Support?

  • Send an email with your request to ncicdiscsupport@nih.gov

What content must be CDISC CDASH Compliant?

  • All CTEP IND studies activated after 1/1/2020 shall be CDISC compliant. 


What content must be CDISC SDTM compliant?

  • While not all data collected will need to be reported  (e.g. safety data), all reported content as defined by the FDA submission  standard must be compliant. 


What actions are needed (from an NCI perspective) if a Common Data Element (CDE) is not required by CDISC?

  • If the CDE is not a required CDISC standard and is needed in your study, submit the request to the NCI CDISC Harmonization WG (ncicdiscsupport@nih.gov) for consideration as a CDISC standard.


What actions are needed to make a partial match CDE compliant with CDISC CDASH requirements? 

  • Use the CDISC CDASH and SDTM supplemental guides to create a new CDISC  CDASH compliant CDE.


What fields need to match for a CDE to be CDISC CDASH compliant?

  • All fields should match all CDISC variables to minimize compliance issues during submission.


Does a CDE with no match to CDISC CDASH/ SDTM require manual creation based on the CDISC CDASH/ SDTM guides? 

  • Yes; create a new CDE that matches the CDISC CDASH requirements.  Contact ncicdiscsupport@nih.gov for additional CDE curation.

What about the CDISC standards that are not geared towards oncology trials?

  • CDISC has developed 4 Oncology Standards:  Breast, Prostate, Colorectal and Lung.  NCI can propose additional domains as needed.


What is the burden of CDISC compliance on legacy trials? 

  • Legacy Trials are not impacted by the CDISC Implementation.


What is the burden of CDISC compliance on new trials? 

  • NCI will follow FDA requirements.  Any required data being reported to the FDA for new trials needs to be CDISC compliant.

How are potential differences between CDUS Complete reporting versus CDASH requirements to be managed?

  • NCI is aware of the various reporting requirements and these will be addressed during impact analysis and implementation activities. 


LPO Specific Questions

We encountered a problem when uploading the CDISC Rave Glib Beta ALS.  It seems there are multiple dictionaries that have commas or semicolons in the coded value, and Rave will not complete the ALS upload while this error stands.


I know that there is a compliance checker for SDTM datasets.  Is there anything available to validate our studies are following CDASH standards (using the Rave ALS)?  If not, is there any plans for this in the future?

  • 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: 

    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.
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