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- Published
- Updated
- Sources checked
A continuing-review calendar needs more than the date a progress report was sent. Investigators and sponsors should track the scope of the IRB decision and the status of ongoing activities so a potential approval gap is identified before it disrupts participant protection.
Identify the applicable framework
21 CFR 56.109 provides for continuing review at intervals appropriate to risk and at least annually. Do not automatically apply flexibility available under some HHS Common Rule provisions to an FDA-regulated investigation. Assess the applicability of both frameworks to the particular research.
Build an IRB status register
For each site and protocol, capture the decision date, approval scope, continuing-review expectations and outstanding conditions. An administrative request in an IRB letter is not necessarily full approval. Under a common IRB arrangement, specify who owns communication between the investigator and the board.
Reconcile the review package
Check participant status, deviations, new safety information and consent changes against a consistent reporting period. Verify the board’s requested content and submission arrangements separately. Explain discrepancies with source owners before submission rather than allowing inconsistent counts to migrate into the IRB’s continuing-review record.
- Read the scope and conditions of the IRB decision.
- Reconcile progress counts against relevant safety information.
- Define escalation triggers before the review deadline.
Manage an overdue review
If review is delayed, promptly evaluate activity status with the investigator and IRB. Do not leave decisions about care needed for participant safety to an administrative reminder. Document the cause, instructions and preventive action; a later decision should not be assumed to retrospectively close an earlier gap.
Frequently asked questions
- Does Common Rule flexibility automatically cover FDA research?
- No. Evaluate which regulations apply to the specific investigation.
- Does sending the package demonstrate continuing approval?
- Not by itself. Track the IRB decision, conditions and status of ongoing activities.