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Clinical Trials Reporting Program

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Accrual

Which trials require accrual reporting?

For trials managed by the NCI's Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) Protocol and Information Offices (PIO) or NCI’s Center for Cancer Research (CCR), accrual will be entered into the Clinical Trials Reporting Program (CTRP) by the NCI. For all National, Externally peer-reviewed and Institutional trials, the Lead Organization listed on the trial in CTRP reports accrual.

What type of accrual reporting is required for multi-institutional trials?

  • Where my organization is the lead?
    • The Lead Organization reports accrual for all patients enrolled in the trial (both in the Lead Organization and in ALL participating sites).
  • Where my organization is a participating site?
    • If you are a participating site in a National, Externally peer-reviewed, or Institutional trial, the Lead Organization will report accrual for your site. Your site does not need to report their accrual as a participating site directly to CTRP but should assure that the Lead Organization has your accrual data for them to report.
    • If you are participating in an Industrial trial, you need to report your site’s summary accrual to CTRP.

What type of patient accrual data should be reported to CTRP?

Patient-level Accrual will be reported for National, Externally Peer-Reviewed, and Institutional trials. Summary Accrual (cumulative count only) will be reported for Industrial trials.

Patient level accrual data includes: 

  • Date Report Submitted
  • Study Identifier
  • Subject Study Identifier (e.g., NCI, CTEP, or DCP Protocol ID Number)
  • Study Site Identifier
  • Zip Code (if US)
  • Country of Residence (if not US)
  • Patient’s Date of Birth MM/YYYY
  • Gender of a Person
  • Ethnicity
  • Subject Registration Date
  • Subject Disease Code
  • Race

See Subject Accrual Data for Complete Trials (http://wiki/nci.nih.gov/display/CTRP/Subject+Accrual+Data+Elements+for+Complete+Trials) for additional information.

How do I report zero accruals on a National, Externally peer-reviewed or Institutional study at my center?

You can do this by submitting via the batch file method the "COLLECTIONS" part of the trial but not the "PATIENTS" section. This will record the trial with zero accrual.

When should patient accrual be reported?

Patient accrual reports are required quarterly. The report should be submitted as soon as possible after the cut-off date at end of the quarter, but no later than 30 days after the cutoff date. The schedule for accrual reporting is as follows:

 

Cut Off DateDue Date
September 30October 31
December 31January 31
March 30April 30
June 30July 31

 

How do I find the CTRP Organization ID for the study site identifier for patient accrual reporting?

Go to the CTRP Registration Site, search for your organization, and select the CTRP Organization ID to use as the study site identifier.

Where can I find additional information regarding accrual reporting?

See our wiki on technical information regarding submission via batch and services and other CTRP User Guide subjects.

Do I need to continue to submit accrual data on a trial that has closed to accrual at our site?

Accrual should be submitted until the trial is closed to accrual and may be submitted until the trial is complete.