July 18, 2018
Meeting Presentation
Welcome to the July 18th CTRP User Call! The topics covered in the 07-18-2018 Presentation are as follows:
- NCI’s Clinical Trials Reporting program (CTRP): Overview
- Rationale
- Source of Clinical Trials
- Distribution and Use of CTRP Data
- CTRP-generated Data Table 4 (DT4) Updates
- Rationale
- Status - CTRP DT4 for Interventional Trials for Non-Competing Applications FY18
- Support and Recent CTRP Updates
- Next Steps
- Next user call will be scheduled for September.
- Topic Request: Review of each CTRP DT4 data element and where the data comes from.
- For any requested agenda topics, please contact the CTRO (NCICTRO@mail.nih.gov).
Discussion/Minutes
- What is the status “Available”?
- “Available” is an Expanded Access trial status. Expanded access trials involve an investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. This is considered an Open status for CTRP-generated DT4 reports. Expanded Access statuses: Expanded Access Statuses
- How does a center define their Org components? What do we do if a site has been added incorrectly? What is the CTEP family?
- The center is responsible or defining these organizational components often referred to as the “CTRP Cancer Center Family”. The family structure is maintained in CTRP by the CTRO, but we look to the centers to confirm the correct family members. There is no “CTEP family”, though CTRP uses organization information from CTEP for participating sites. The accruals are added to the CTRP-generated DT4 based on the “CTRP Cancer Center Family”.
- Organizational relationships have accrual that goes to the Center Reporting Period and Center to Date columns on your CTRP-generated DT4 report.
- Affiliation type relationship accrual goes to Other Reporting Period and Other to Date columns on your CTRP-generated DT4 report
- Please refer to the CTRP DT4 Data Elements Wiki page for more information: Data Elements Included in the CTRP Data Table 4 Report.
- The PDF version does not have our comments that are included on the Excel spreadsheet.
- The Office of Cancer Centers (OCC) requested a clean version without the comments (read-only representation of data) but the clean version and version with comments are submitted on the centers’ behalf to the Office of Cancer Centers CCSG mailbox in support of a non-competing interventional CTRP-generated DT4 submission.
- Which columns on CTRP-generated DT4 are determined by CTRP, i.e. abstracted by the CTRO, regardless of Cancer Center entry, like Primary Site?
- We will provide a CTRP-generated DT4 field by field review on the next meeting.
- When different NCI organizations have not responded in a timely manner, is NCI responsible for following up?
- If you are not receiving a timely response, please send an email to the CTRO ( NCICTRO @mail.nih.gov) and they can perform this outreach on your behalf.
- Would like to see that CTRP allows an administrator to submit status and accrual updates to more than one family member.
- This feature is currently in development, CTRP will be enhanced to allow administrators to edit/update data for any site that is considered part of their CTRP Cancer Center Family.
- Will there be guided expectations for how to review the accrual for site visits vs. DT4 reports?
- Dr. Ciolino, Office of Cancer Centers: Yes, guidance will be coming. Site visits represent data that was previously submitted to the Office of Cancer Centers.
- What do we do when the names of sites we are given are different than what is in CTRP? Is there a way to get everything consistent?
- If you have a request to change your center name and/or any of your family member organizational name(s), please send an email to the CTRO (NCICTRO @mail.nih.gov) and they will review and follow-up accordingly.
- Note: CTRP requires unique organizations. If there are two organizations at the same address, we need to confirm they are indeed different organizations. If they are, we look to change the name so that names are different.
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