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• CTRP Trial Registration and Scope
  • Can you please clarify the registration of expanded access studies, should they be registered in CTRP?
    • CTRP requests centers to register Expanded Access trials in CTRP by importing the record into CTRP from ClinicalTrials.gov.  (slide 1817)
  • What if an NCT ID is missing for expanded access?
    • For any trials requested to be imported (including Expanded Access) to CTRP without an NCT ID, please contact the CTRO (NCICTRO@mail.nih.gov).  CTRO can confirm if the trial is in scope for CTRP and if so, will facilitate registration (slide 3940)
  • Should Ancillary/Correlative studies be registered in CTRP?
    • CTRP supports registration of Ancillary/Correlative studies.  There is no current requirement to register these studies in CTRP. (slide 27)
  • When should a cancer center that is planning to submit for an initial CCSG award begin registering protocols in CTRP?
    • The center can start to register any NIH grant funded trials as soon as possible, but they should hold off an any additional trials until the grant is awarded.  The center should contact their Office of Cancer Centers (OCC) Program Director for specific questions.
  • If a study is imported from Clinicaltrials.gov, how soon can we see it displayed in our CTRP-generated DT4? Also is there any additional information required to complete registration of study once imported from clinicaltrials.gov?
    • Once the trial has been Imported, a site must add themselves as a Participating Site (PS) before the abstraction process begins.  After the trial is abstracted, it will be available on a CTRP-generated DT4 report if the status dates are in scope for the reporting period.  The abstraction process is completed by the CTRO within 10-business days after registration (both new trial and amendment registrations).
• Record Verification Process
  • How can we access the list of studies for our center which have not been verified in CTRP within the last 6 months?
    • This can be found in CTRP Registration (slides 12 & 13)
  • Who will the emails indicating which trials are due for Record Verification in CTRP be sent to?
    • The email notifications will be sent to Site Admins, Trial Owners and Trial Submitters. 
  • Will we be able to download the list of trials that are due for record verification into a CSV or Excel report?
    • Yes, there will be a download option for the trials requiring record verification.
• Accrual Questions
  • Regarding the recent Flex Accrual release changes, a center must request (and get approval for) the ability to report Summary accrual on Complete Interventional trials. Why must we gain approval to report Summary accrual data for a non-treatment healthcare delivery research type of protocol?
    • CTRP policy is to collect Subject accrual on all Interventional trials (even non-treatment trials).  The exception to allow the reporting of Partial Subject or Summary accrual requires a case-by-case review of the protocol for Interventional trials before approval is granted.
  • Has there been any additional thought about multi-step studies, trials that include a screening and treatment component?  These trials are becoming more frequent and the sponsors count both types of accrual steps.  How are Observational multi-step accruals to be counted?

    • For Interventional multi-step trials, the Interventional step (not the screening step) would be counted for accrual (with the exception of MATCH, Alchemist, and Lung Map trials).

    • For Observational multi-step trials, the Observation step (not the screening step) would be counted for accrual.

• Other Topics
  • The "Entire Study" column on the CTRP-generated DT4 report is the only way for an Investigator Initiated Trial Lead Org receive "credit" for all accrual reported on the trial (other than accrual within the Center's family).  How final is the decision to remove it for the CTRP-generated DT4 PDF?
    • This change was made in order to allow the CTRP-generated DT4 report to match the eRA Commons size requirements for Competing CTRP-generated DT4 submissions.  The center also has the option to download the Excel version and create a PDF version to include this column.
  • Would it be possible with the planned updates to add the correction templates on the registration page?
    • CTRP follows NCI guidelines for the CTRP log-in pages.  The CTRP Data Correction templates will remain in the CTRP User Guide wiki:  https://wiki.nci.nih.gov/x/iQgXG. 
  • We need to be able to have Open and Closed dates on National trials within a more narrow time frame than six months from either the Open or Closed dates. The NCI may think it's fine to have this type of discrepancy, but reviewers during competing review will be reviewing our CTRP-generated DT4 for low accruing studies. If a study Open or Close date is 5 months inaccurate, this can negatively impact our review.
    • The NCI is aware of these date differences and is working to align these more closely to the PS level dates for their center, moving forward. In the interim, for any trials that require a PS status update, please contact the CTRO (NCICTRO@mail.nih.gov) for assistance.
  • If the Lead Org requests to remove an observational trial from a CTRP-generated DT4, how will the participating site report it?
    • Trials can be removed from all sites on a CTRP-generated DT4 report at the Lead Orgs request/approval (e.g., non-cancer trial) or removed only from a certain participating site(s) (e.g., Expanded Access trial) at the sites request.  If there is a concern with a trial that was removed from your CTRP-generated DT4 report, please contact the CTRO (NCICTRO@mail.nih.gov).

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