This page provides an overview of the key processes involved in closing a clinical research study. It contains resources designed to support research teams and ensure compliance with regulatory standards.
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Accrual Closure | Final Closure | Closure of Studies under an IND
When a study transitions to ending enrollment, it is essential to update both the Institutional Review Board (IRB) and the OnCore Clinical Trials Management System (CTMS) to reflect the study status. Future study reviews are informed by ongoing treatment, follow-up and/or data analyses activities, which may also impact federal reporting requirements.
Updating the OnCore CTMS initiates a series of important updates across research systems, including, but not limited to:
- Notifying relevant clinic offices of the recruitment status
- Discontinuing accrual monitoring by the Scientific Review Committee (SRC)
- Assessing and updating future monitoring plans
- Determining appropriate renewal review types
- Updating ClinicalTrials.gov and initiating results reporting in accordance with regulatory deadlines
- Updating National Cancer Institute databases within required timeframes
Upon completion of all study-related activities, it is essential to update both the IRB of record and the OnCore CTMS to accurately reflect the study status. Updating the OnCore CTMS initiates a series of important updates across research systems, including, but not limited to:
- Notifying relevant clinic offices of the final closure
- Finalizing the ClinicalTrials.gov record
- Verifying all participants are off-study
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.
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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.