October 11, 2017

Meeting Presentation

Welcome to the October 11^th 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
  • The recently implemented Cut Off Date feature for Industrial trials may be used to correct previous submissions.  Please contact CTRP_support@mail.nih.gov to correct your Industrial accrual data.  For instructions on submitting Abbreviated accrual: https://wiki.nci.nih.gov/display/CTRPdoc/Working+with+Abbreviated+and+Other+Trial+Accruals
  • For Industrial trials, Center12Mos is calculated using the Cut Off dates. 

Requests

• NCI will explore providing the NCI ID in a separate column instead of concatenating with the “Other IDs” section of the CTRP DT4.