Page History

...

• Will registration for Observational studies in CTRP follow the same process? 
  • Yes, submitting the protocol document, IRB Approval document and any other supporting documentation will be expected. 
• If a center has reported all non-interventional studies (Observational and Ancillary Correlative) in CTRP already, and is satisfied with the non-interventional report as-is (e.g., includes both Observational and Ancillary Correlative studies), can they turn in a single non-interventional DT4 report with all non-interventional study data in support of their non-competing application?
  • Yes, the NCI Office of Cancer Centers has agreed to this option if the center would like to submit their non-interventional CTRP DT4 report with both Observational studies and Ancillary Correlative included.
• Will the NCI expect accrual at the detailed level instead of summary accrual for Observational studies in the future?
  • No.  CTRP can capture patient level accrual and supports the reporting of this detailed level of accrual, but it is not required.
• Will ClinicalTrials.gov registration be required for Observational studies?
  • NCI does not control ClinicalTrials.gov registration requirements.
• How will CTRP handle Observational studies which are externally sponsored for sites, but are not in ClinicalTrials.gov?
  • These trials will be handled and reviewed on a case by case basis.  If any of these studies come up as an issue, please contact the CTRO (NCICTRO@mail.nih.gov) to assist with registration.  CTRO has a workaround mechanism to register a study in CTRP without a ClinicalTrials.gov record/NCT ID.

CTRP Discrepancy Follow-up Process

...