May 3, 2023
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Meeting Presentation
Welcome to the May 5 CTRP User Call! The topics covered in the 2023-05-03 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
- Recent updates
- Observational Studies (Slide 5):
- 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
- Accrual Reporting for Participating Sites by Lead Organizations (Slides 22 - 24)
- 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.
Discussion/Minutes
To Be Provided
Contact Links
- CTRO Mailbox (NCICTRO@mail.nih.gov)
- To join the CTRP Users Listserv (https://go.usa.gov/xM386)