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August 25, 2020

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Meeting Presentation

Welcome to the August 25 CTRP User Call!  The topics covered in the 08-25-2020 Presentation are as follows:

  • Recent & Planned Updates

    • Recent Updates:
      • Flexible Accrual Reporting
      • Country Code Requirements
      • Zip Code Requirements
      • ICD-O-3 Disease Code Requirements
      • Display of Rejected/Submission Terminated Studies (in CTRP Registration Module)
    • Planned Updates:
      • Trial Record Verification Process (confirming, updating, identifying, emailing communication)
      • General Forms Updated User Interface for consistency

  • Expanded Access Trials

  • CTRP Generated Data Table 4

    • Interventional Trials (Scope and Reporting Requirements)

      • PDF Format Change

    • Observational Studies (Scope and Reporting Requirements)

    • Ancillary-Correlative Studies

    • Data Correction Requests: Follow-up Process

    • CTRP Reporting Requirements by Centers
      • NIH/NCI Grant Funding Information
      • Reporting Sex vs. Gender with CTRP Accrual Reporting
  • User Account Management
    • OKTA Migration > Centralized CTRP Login
    • CTRP User Account Process
  • Center Q & A
  • Next Steps
    • CTRP Generated DT4 Reporting
      • Interventional trials:  Cancer Centers to continue supporting CTRP generated DT4 submissions for non-competing and competing applications  
      • Observational studies: 1). Cancer Centers to initiate (or continue) to register Observational Studies in CTRP open to accrual on or after
        January 1, 2018 and 2). participate in upcoming FY 21 reconciliation activities
    • Planned CTRP release details for Registration Trial Record Verification and user interface updates as well as the Okta migration for user accounts to be communicated via CTRP ListServ communications
    • Please continue to send any future CTRP User Call agenda topics to the CTRO NCICTRO@mail.nih.gov
  • Next user call is to be determined 

Discussion/Minutes

Pre-asked questions

  • How should the LO report accrual in each of the following?
    • Patient transfers INTO the lead org site from a participating site (the patient becomes a LO site patient treated by a LO site investigator)
      • The patient would not have enrolled to the study under LO site investigators
    • Patient transfers FROM the LO site to a participating site (the patient is no longer being treated by a LO site investigator at the LO site)
      • The patient would have enrolled to the study under a LO site investigator
  • How do I register an Observational study that doesn't have an NCT ID 
    (not registered in ClinicalTrials.gov)?
    • Please contact the CTRO NCICTRO@mail.nih.gov to request assistance with registering Observational studies without an NCT ID
  • Is the inclusion of expanded access trials on the CTRP DT4 still optional? 
    • The reporting of an Expanded Access trial on a center-specific CTRP-generated DT4 is still at the discretion of the cancer center
    • If you have an Expanded Access trial registered in CTRP that you would like to exclude from your CTRP-generated Data Table 4 report, please send a message to the CTRO (NCICTRO@mail.nih.gov) to request exclusion
  • With expanded access protocols being in DT4, will single patient expanded access (compassionate use protocols) also be included?
    • No, single patient compassionate use studies are out of scope for CTRP

Open Discussion Questions (answered during meeting)

  • What is the location on the Wiki to download ICD-O-3 code lists when there are updates?
  • The number of observational studies without an NCT number is likely to be extremely high. Why are these being treated as one-offs?
    • The one-off situations are only for Industrial trials (not an Investigator Initiated (IIT) or National Trial) that would be traditionally imported from ClinicalTrials.gov.  For these instances where an NCT ID is not available, the CTRO currently has a mechanism to get the trial into CTRP, but this mechanism may be updated based on the scope of trials.
  • How often, if ever does CTRP run a comparison of Center CTRP data against CT.Gov? I ask as we've had a recent issue where we are not the lead organization for an IIT, but our internal data matches that of CT.Gov. It does not, however, match CTRP and has created an inconsistency in our report.
    • We do not formally compare all data between CTRP and ClinicalTrials.gov.  For imported studies, we look at ClinicalTrials.gov to be the source of the trial level data.  For non-imported studies (IIT and/or National studies), we look to the data submitter to provide any trial level data and updates.  On an ad hoc basis, the CTRO may contact the lead organization if there is an obvious reporting issue.

  • How are centers to count accrual for a participant who withdrew consent prior to starting treatment? Should these accruals be reported on the CTRP-generated DT4 report?

    • Currently, National Sources counts a patient once they have signed the consent, even if the patient withdraws at a later time.  The CTRP team will discuss this topic with the Office of Cancer Centers to provide additional feedback.  SW:  Susan is checking past minutes to see if this has been asked/answered to be consistent in the wording.

  • Will the Accrual API be affected by the switch to 2-part authentication?

    • The authentication will change but 2-factor authentication will not be required, as the API user will have a token with their authentication.

Additional Questions Asked During Meeting 

  • 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 18)
    • What if 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 this trial is in scope for CTRP and if so, will facilitate registration (slide 39)
    • Should Ancillary/Correlative studies be registered in CTRP?
      • CTRP supports registration of Ancillary/Correlative studies.  There is no current requirement to register these studies. (Slide 26)
    • When should a cancer center that is planning to submit for an initial CCSG award begin registering its 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.
    • How can we access the list studies for our center which have not been verified in CTRP within the last 6 months?
      • This can be found in Registration (slide 13)  SW:  we need to confirm that they can see these currently in Registration (I <believe> they can,) as slide 13 represents the "to-be" after the RVD release.
    • If a study is imported from Clinicaltrials.gov - How soon can we see it displayed in out CTRP 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 before the abstraction process begins.  After the trial is abstracted, it will be available on a CTRP-generated DT4 report.  The abstraction process is completed by the CTRO within 10-business days after registration.
  • Verification Process
    • Who will the emails indicating which trials are due for data verification in CTRP be sent to?
      • The email notifications will be sent to Site Admins/Trial Owners/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, centers must request to report Summary accrual on Complete Interventional trials, which then needs to be approved. 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 Partial or Summary accrual would be on a case-by-case basis for Interventional trials.
    • Has there been any additional thought about 2 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 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 DT4 PDF?
      • This change was made in order to allow the CTRP-generated DT4 report to match the eRA commons size requirements for Competing 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 new updates to add the correction templates on the registration page?
    • We need to be able to update open/close dates within a more narrow timeframe of six months. the NCI may think it's fine to have this type of discrepancy, but reviewers of our centers during competing will review our DT4 for low accruing studies. If a study open or close date is 5 months inaccurate, this can negatively impact our review if the data is inaccurate by that duration of time.
      • For any trials that require a participating site update, please contact the CTRO (NCICTRO@mail.nih.gov) for assistance.
    • If the lead org requests to remove an observational trial from DT4, How will the center report it?
      • There are options for a trial to be removed from all DT4 reports (example, non-cancer trial) or to be removed from only certain participating sites (example, Expanded Access trial).  If there is a concern with a trial that required a flag or a flag removal, please contact the CTRO (NCICTRO@mail.nih.gov).


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