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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. 


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