August 14, 2019
Meeting Presentation
Welcome to the August 14 CTRP User Call! The topics covered in the 08-14-2019 Presentation are as follows:
- Recent CTRP Updates
- CTRP enhanced the capture of ICD-O-3 study accrual disease data capabilities to support accurate reporting in CTRP on July 8, 2019
- CTRP Generated DT4 Schedule
- CTRP Family (Organization, Affiliates)
- CTRP Discrepancy Follow-up Process
- CTRP Accrual Reporting Batch File Submissions
- Abbreviated/Imported trials
- Next user call will be scheduled for first quarter 2020
Discussion/Minutes
Recent CTRP Updates/ICD-O-3
- When will the follow up for potentially missing topography/morphology occur with the centers?
- The plan is to incorporate this outreach with typical CTRO outreach to each center who will need to resubmit their accrual data using ICD-O-3 disease terminology to CTRP.
- If your center uses ICD-O-3 codes and would like to review sooner, please feel free to contact the CTRO (NCICTRO@mail.nih.gov) to review and reconcile.
CTRP Generated DT4 Schedule
Observational Trials
- What is the rationale for submitting Ancillary Correlative and Observational studies separately, instead of just non-interventional?
- CTRP is starting with Observational studies because of the structured information available on these types of studies, and to space out changes/reduce impact to the cancer center community in support of this transition.
- Accrual and other details need to be defined by the NCI for Ancillary Correlative studies.
- Will registration for Observational studies in CTRP follow the same process?
- Yes, submitting the protocol document, IRB Approval document and any other supporting documentation will be expected.
- If a center has reported all non-interventional studies (Observational and Ancillary Correlative) in CTRP already, and is satisfied with the non-interventional report as-is (e.g., includes both Observational and Ancillary Correlative studies), can they turn in a single non-interventional DT4 report with all non-interventional study data in support of their non-competing application?
- Yes, the NCI Office of Cancer Centers has agreed to this option if the center would like to submit their non-interventional CTRP DT4 report with both Observational studies and Ancillary Correlative included.
- Will the NCI expect accrual at the detailed level instead of summary accrual for Observational studies in the future?
- No. CTRP can capture patient level accrual and supports the reporting of this detailed level of accrual, but it is not required.
- Will ClinicalTrials.gov registration be required for Observational studies?
- How will CTRP handle Observational studies which are externally sponsored for sites, but are not in ClinicalTrials.gov?
- These trials will be handled and reviewed on a case by case basis. If any of these studies come up as an issue, please contact the CTRO (NCICTRO@mail.nih.gov) to assist with registration.
CTRP Discrepancy Follow-up Process
- What if you do not agree with the primary purpose from the Lead Organization?
- The NCI relies on the Lead Organization to provide trial level data, such as Primary Purpose, Sponsor, Phase, etc. If there is an instance where a center feels this data is incorrect for the trial, please contact the CTRO (NCICTRO@mail.nih.gov) directly to review. The expectation is this data will be the same for the trial and all participating sites across the trial, not changed specifically for any one site on the trial.
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