Page History

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• 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 GovDelivery please click the link https://gopublic.usa.gov/xM386 and govdelivery.com/accounts/USNIHNCI/subscriber/new?cid=eb_govdel&topic_id=USNIHNCI_265 and register.  Please provide this link to any colleagues who would like to join.

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