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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 is a "consortia trial" in CTRP, and how do I report accrual for a "consortia trial" in which my organization participates?

A consortia trial is a multi-institutional trial, within scope for CTRP, which does not fall within the current guidelines for Data Submission and Accrual Reporting for trials in the Institutional, Peer-Reviewed, or National categories. Consortia trials are registered in CTRP as Industrial/Other.

Only summary accrual is reported for consortia trials, similar to accrual reporting for Industrial trials. Please provide summary accrual for your site in each industrial or consortia trial in which your center is a participating site.

What information is required for reporting subject accrual or trials in CTRP?

  • For Industrial and Consortia trials, only summary accrual (cumulative count) should be reported.
  • For National, Externally Peer-Reviewed, and Institutional trials, patient-level accrual should be reported. Note that accrual for trials managed by CTEP or DCP PIO, as well as CCR, will be transferred within NCI to CTRP.

A complete list of accrual data elements for complete trials can be found in the CTRP Subject Accrual User's Guide v3.10.

What type of patient accrual data should be reported in 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 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.

 

Am I required to report accrual for Non-Interventional trials?

At this time, accrual reporting is not required for non-interventional trials, although CTRP can accept accrual reporting (e.g., summary accrual) for these trials.

How do I submit accrual for National, Institutional, or Externally Peer-Reviewed trials if the files are missing required data elements?

Patient-level data elements must be entered for Institutional, National and Externally Peer-Reviewed trials. Accrual Submissions will fail if all required elements are not included. As of September 2012, consent forms and workflow processes should have been amended to capture and allow transmission to CTRP of all required patient-level data elements.

In the rare case that a data element may be missing in a legacy trial, contact the CTRP Program Director or the CTRO at ncictro@mail.nih.gov to discuss possible solutions.

How will I know if my accrual submission was successfully uploaded in CTRP?

An email notification from the NCI CTRO will be sent to the user confirming a successful or unsuccessful accrual submission. Contact the CTRO at ncictro@mail.nih.gov if you have questions about your accrual submission or do not receive email notification for your accrual submission.

What should I do if I receive an error message after attempting to submit accrual?

The error message will specify why the submission was unsuccessful. Once the errors have been resolved, please submit the file to the CTRP Accrual Site.

How do I submit accrual for a participating site on a National, Externally Peer-Reviewed, or National trial in CTRP that is not currently listed on a "complete" submission?

  • If the trial is managed by CTEP PIO or DCP PIO, please contact the PIO and request addition to the trial record.
  • If the trial was submitted directly to CTRP by the lead organization, please contact the lead organization and request addition as a participating site. The lead organization is responsible for registering the trial, participating sites, and reporting accrual for all participating sites to CTRP.
  • If the trial has not been submitted to CTRP by the lead organization and the lead organization is not supported by NCI (e.g., NCI Designated Cancer Center or a NCI awardee), contact the CTRO for guidance regarding how to register the trial and report accrual at ncictro@mail.nih.gov.

Why am I unable to assign myself or another user accrual access to trials that are greyed out in the Manage Accrual Access tab in the CTRP Registration Site?

There are three primary reasons trials cannot be assigned for accrual access:

  • The trial was recently submitted to CTRP and its abstraction process is not yet complete.
  • The trial has a current processing status of "On-Hold". To request the reason for the On-Hold status, please contact the CTRO at ncictro@mail.nih.gov.
  • The trial has a trial status of "In Review". The status must be updated by the submitter before accrual can be reported.

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.