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An IND annual report needs consistent study status, participant counts, safety information and forward planning. A reconciliation record helps the sponsor explain differences between operational systems before the annual narrative is approved and submitted.
Define the reporting period
21 CFR 312.33 links the progress report to the anniversary of IND effectiveness and requires submission within the following 60 days. Retain evidence of the effectiveness date; calculating the deadline only from the first transmission can create an incorrect calendar.
Reconcile the study inventory
Compare the protocol inventory with clinical operations, data management and safety records. Show the cutoff used for planned, entered, completed and withdrawn participant counts. Treat a completed study incorrectly shown as ongoing as a discrepancy requiring a documented resolution.
Check the report
A concise reconciliation record should identify each number, its source and the resolution of differences. When a count changes, examine the explanation and any effect on medical interpretation as well as correcting the table. Ask the source owner to confirm the final disposition.
- Verify the IND effectiveness date against source correspondence.
- Reconcile participant status counts at a shared cutoff.
- Compare the future plan with the safety summary.
Evaluate the DSUR connection
FDA E2F guidance discusses DSUR use; evaluate the chosen format alongside regional requirements. Preparing an annual report or DSUR cannot justify delaying expedited safety reporting. Keep the coming-year investigation plan consistent with the current risk assessment and identify unresolved development decisions.
Frequently asked questions
- Is the anniversary the original transmission date?
- Use the IND effectiveness record and distinguish delivery from effectiveness.
- Can an annual report replace urgent reporting?
- No. Expedited safety reports follow their own applicable conditions and reporting periods.