Closure to Accrual
In addition to keeping the Institutional Review Board (IRB) and OnCore Clinical Trials Management System (CTMS) up to date on the status of the study, this sets in motion other changes in our research system such as:
- Notifying appropriate clinic offices of the study closure
- Discontinuing SRC accrual monitoring
- Correctly assessing future monitoring plans
- Correctly predicting future renewal review types
- Updating ClinicalTrials.gov within regulatory deadlines and planning for results reporting
- Complying with National Cancer Institute policies by updating CTRP and CCSG data tables within required timeframes
Whether a study continues to see patients for treatment or follow-up vs data analysis will determine how the study is reviewed in coming years and may also impact reporting to the ClinicalTrials.gov and the National Cancer Institute. The closure to accrual status change should be documented in OnCore with the reason for closure.
Closure of Studies under an IND
When all study activity conducted under an IND is fully completed and there are no further studies planned under the IND, a request to withdraw the IND should be submitted to the FDA. When a study under a IND has been fully closed but other studies remain open, the FDA should be notified of the individual study closure in an Information Amendment. In certain situations when no study activity is occurring, but it is preferable not to withdraw the IND completely, it may be appropriate to place the IND on “inactive” status.
Please contact CRS Regulatory Affairs for guidance or templates regarding these types of submissions.
Clinical Research Support is here to assist and guide study teams. Please contact us if you need anything not found in these resources, or need clarification on how to proceed with your study.