Clinical Research Support

Closing Studies

Closure to Accrual

When a study closes to accrual, a modification form should be submitted to the IRB. In cases where a Continuation Review Report (CRR) happens to be occurring at the time of closure, it can be used to document the change in status. In addition to keeping the IRB up to date on the status of the study, this sets in motion other changes in our research system such as:

  • Allowing Clinical Research Support to remove the consents from Clinical FYI
  • Notifying appropriate clinic offices of the study closure
  • Correctly assessing future monitoring plans
  • Correctly predicting future renewal review types
  • Notifying ClinicalTrials.gov that the study is no longer recruiting

Specifying the type of continued study activity is important when reporting a closure to accrual. Whether a study continues to see patients for treatment or follow-up vs. solely doing data analysis will determine how the study is reviewed in coming years and may also impact reporting to NCI and ClinicalTrials.gov. Email submissions@fhcrc.org for details on how to document the closure to accrual correctly.

 

Final Closure

A final study closure -- closure to accrual and no further data analysis or patient care -- requires submission of a Continuation Review Report to the IRB. To ensure you document the closure correctly, contact submissions@fhcrc.org.

For further information on the IRB process, you can visit their page here.

Menu Search