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Welcome to the May 5 CTRP User Call!  The topics covered in the 2023-05-03  Presentation are Presentation are as follows:

  • Recent CTRP Updates

    • Observational Studies (Slide 5):
      • Scope for registration of Observational studies in CTRP has changed to those open to accrual as of or after 1/1/2020
      • For Observational studies currently registered in CTRP, which closed to accrual prior to 1/1/2020, study amendments are no longer required
    • Ancillary-Correlative Studies (Slide 6):
      • Registration of Ancillary-Correlative studies in CTRP is no longer in scope
      • Amendments submitted for currently registered Ancillary-Correlative studies will be rejected
    • Pragmatic Trials (Slides 7 - 13)
      • CTRP TSR now displays the new pragmatic trial indicator
      • CTRP-generated DT4 now displays the new “Prag” column with pragmatic
        trials filtered at the end of the report
      • CTRO will continue to classify which trials are pragmatic in CTRP, working
        with Cancer Centers as-needed to further categorize
      • NCI will work with the community prospectively to update and refine the
        definition as needed
    • Clinical Trials Search API (Slide 14)
      • Recent updates
        • 2021 - CTS API Version 2 (v2) released
        • 2022 - Prior therapy structured eligibility criteria on a small subset of trials
  • Registration
    • Submission Requirements (Slides 16 - 18)
    • Managing Multi-Institutional Trials (Slide 19)
    • Externally Peer-Reviewed Trials (Slide 20)
  • Accrual 
    • Accrual Reporting for Participating Sites by Lead Organizations (Slides 22 - 24)
      • Timely Reporting
      • Timely Responses to Data Requests
  • CTRP Data Table 4 (Slides 26 - 29)
    • Interventional Trials
    • Observational Trials
    • Ancillary-Correlative Studies
    • Discrepancy Follow-up Process
  • Data Correction Requests
    • Discrepancy Follow-up Process (Slides 31 - 35)
    • CTRP Reporting Requirements by Center (Slide 36)
  • Other Topics
    • Resources (Slides 38 - 39)
    • CTRP User Account Manager (Slide 40)
    • CTRP Communications (Slides 41 - 42)
  • 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://go.usa.gov/xM386).  Please provide this link to any colleagues who would like to join the Listserv.

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