August 25, 2020

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 
• Please submit any future CTRP user call agenda topics to the CTRO (NCICTRO@mail.nih.gov).
• To join the CTRP Users Listserv (https://list.nih.gov/cgi-bin/wa.exe?SUBED1=ctrp-users-l&A=1).  Please provide this link to any colleagues who would like to join the Listserv.

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

• What is the location on the Wiki to download ICD-O-3 code lists when there are updates?
  • The lICD-O-3 code lists can be found at this link: https://wiki.nci.nih.gov/display/CTRPdoc/Accrual+Data+Elements+with+CTRP-Accepted+Values+for+Complete+Trials
• 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 referred to here are only for industrial trials (not an Investigator Initiated or National Trial) that would be traditionally imported from ClinicalTrials.gov.  For these instances where an NCT ID is not available, 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 hock basis, CTRO may contact the lead organization if there is an obvious reporting issue.

    
    

• Can David also speak to how centers are to count a withdraw of consent prior to starting treatment? Should these count as an accrual reportable on the DT4?

  • David to follow-up.  

    
    

• David, will API be affected by the switch to 2-part authentication?

  • The services should be updated and our team will confirm that any change will not affect users.

Contact Links

• CTRO Mailbox (NCICTRO@mail.nih.gov)
• To join the CTRP Users Listserv (https://list.nih.gov/cgi-bin/wa.exe?SUBED1=ctrp-users-l&A=1)