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Accrual Reporting

Accrued subject/enrolled participant is defined as follows: "Enrolled means a participant's, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol”  

For all national, externally peer-reviewed and institutional trials, the Lead Organization listed on the trial in CTRP reports accrual.

For trials managed by 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 data will be entered into the Clinical Trials Reporting Program (CTRP) by the NCI.

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

Cut Off Date

  • September 30
  • December 31
  • March 31
  • June 30

Due Date

  • October 31
  • January 31
  • April 30
  • July 31

Patient-level accrual will be reported for national, externally peer-reviewed, and institutional trials. Patient-level accrual data includes:

  • Date Report Submitted
  • Study Identifier (e.g., Lead Org, NCI, CTEP, or DCP Protocol ID Number)
  • Subject Study Identifier
  • 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

Summary accrual (cumulative patient count) is reported for consortia trials (multi-institutional trials that do not fall within the guidelines for institutional, peer-reviewed, or national trials) and industrial trials. The participating site needs to report summary accrual data for their site.

  • Updated: