October 11, 2017
Meeting Presentation
Welcome to the October 11th CTRP User Call! The topics covered in the 10-11-2017 Presentation are as follows:
- CTRP DT4 Reporting
- Scope of Trials on Report
- Observational and Ancillary-Correlative Studies
- Multi-site Trial: Source of Data
- Trial Status Transition Rules
- Accrual Reporting
- Basket/Umbrella Trials
- Trial Phase
- Special Notes: No duplicate trials and a closed date may be provided on report, even if it is after the time period of the report.
- Data Elements/References
- Submission Process
- New CTRP Data Reporting System
- Recent CTRP Updates
- Planned CTRP Updates
Discussion/Minutes
- Program Code is required to have a complete Data Table 4 (DT4) submission but is not a CTRP requirement.
- CTRP supports the following patient-level disease coding systems: CTEP SDC, ICD-9, ICD-10, and ICD-03. If there are issues with submission, please contact the help desk, CTRP_support@mail.nih.gov
- All data for NCI-MATCH and other National trials comes internally from NCI Systems. Centers do not report directly to CTRP, data is reported on a Center’s behalf. Centers are responsible for submitting Center-specific DT4 data such as Program Code and Center Target Enrollment.
- CTRP DT4 will include a column for Local Trial ID. Centers may add a Local Trial ID for any trial, e.g. internal IRB number. Centers may submit a request to batch load Local Trials IDs.
- CTRP can generate a CSV and PDF version of CTRP DT4.
- Centers specify the Fiscal Year and Reporting Period for the CTRP DT4. A Center may select any date range they like for the DT4 report. Selecting a specific Fiscal Year does not select specific date ranges.
- CTRP DT4 relies on the lead org for the overall trial and participating site status open and close dates. NCI understands the overall trial may be open before a Center opens to accrual.
- CTRP provides a Services Interface for any Commercial Vendor that would want to directly connect with CTRP.
- CTRP Site Admins may designate others at their Center to run a CTRP DT4 report. Please contact CTRP_Support@mail.nih.gov with any questions.
- Imported/Abbreviated/Industry Trials
Requests
- NCI will explore providing the NCI ID in a separate column instead of concatenating with the “Other IDs” section of the CTRP DT4.