An accrued subject or enrolled participant is defined by "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” per ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies.
For all national, externally peer-reviewed and institutional trials, the Lead Organization listed on the trial in CTRP reports accrual.
Accrual data will be entered by NCI into the Clinical Trials Reporting Program (CTRP) for trials managed by
- NCI Cancer Therapy Evaluation Program (CTEP)
- NCI Division of Cancer Prevention (DCP)
- NCI Center for Cancer Research (CCR)
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
- March 31
- June 30
- September 30
- December 31
- April 30
- July 31
- October 31
- January 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 U.S.)
- Country of Residence (if not U.S.)
- Patient’s Date of Birth MM/YYYY
- Gender of a Person
- Subject Registration Date
- Subject Disease Code
Partial Subject: Partial Subject accrual was implemented for unique instances when Full Subject/Patient-Level accrual reporting is not possible. Partial Subject accrual data includes, at a minimum, the reporting of Study Subject ID, Registration Date and Participating Site data. The other accrual data fields are optional when reporting via Partial Subject accrual.
* The reporting of Partial Subject accrual on a Complete Interventional trial requires approval. Please submit the request to CTRO (NCICTRO@mail.nih.gov). For additional information on the reporting of Partial Subject accrual, please visit https://wiki.nci.nih.gov/display/CTRPdoc/About+Accrual or submit an inquiry to CTRO (NCICTRO@mail.nih.gov).
Summary accrual, or the cumulative patient count, is reported for industrial trials and consortia trials (multi-institutional trials that do not fall within the guidelines for institutional, peer-reviewed, or national trials). Each participating site needs to report its own summary of accrual data.