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Welcome to the September 14 CTRP User Call! The topics covered in the 09the 09-14-2021 Presentation 2021 Presentation are as follows:
Recent & Planned Updates
- Recent Updates (Slides 5 – 13):
- Enhancements to Accrual Reporting
- Augmenting Security (User Account Management) – Transition to Okta
- Improvements to Trial Record Verification
- Support of CTRP-generated Data Table 4
- Registration: IRB and NIH Grant Information (NCI Funded)
- Planned Updates (Slides 15 – 16):
- CTRP ListServ “CTRP Users” to be transitioned to a new communication mechanism “GovDelivery”
- CTRP System Downtime Notification (9/18/2021)
- Recent Updates (Slides 5 – 13):
- “Other” Trials, e.g., Pragmatic, Non-Consenting (Slides 18 – 24)
- CTRP-Generated Data Table 4 (Slides 26 – 37)
- Interventional Trials
- Observational Studies
- Ancillary-Correlative Studies
- Data Correction Requests: Follow-up Process
- User Account Management (Slide 39)
- Other Topics/Center Q & A (Slides 41 – 43)
- Next Steps (Slide 44)
- CTRP-Generated DT4 Reporting
- Interventional trials: Cancer Centers to continue submitting 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 Trial Record Verification and user interface updates as well as the Okta migration for user accounts to be communicated via CTRP ListServ communications
- CTRP-Generated DT4 Reporting
- 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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- For the NCI Funded change for indirect and direct funding, are these changes only going forward or will they be retroactive?
- CTRP has retroactively added the indirect/direct funding for trials already in the system.
- Can you reiterate the reason for registering studies that have no direct or indirect NCI funding?
- NCI’s expectation is that all studies at a Cancer Center will have at least indirect funding. The option to support No NCI Funding is for other trials that may be added into CTRP in support of expanded cancer clinical trial search requirements and/or VA studies, e.g., Veterans Affairs (VA) cancer clinical trials.
- Will NCI funded be added to DT4 or is this just CTRP data being collected for other purposes?
- There is no current expectation to include a data element for NCI Funded on the DT4 report.
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