21 CFR 312.64 - Investigator Reports

What it says

An investigator must give the sponsor adequate reports of the progress of the investigation. Any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug must be reported to the sponsor promptly, and serious adverse events must be reported immediately. The investigator must provide a final report within three months after completion of the investigation and must give the sponsor financial disclosure information.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The sponsor depends on the investigator's reports to meet its own safety reporting duties to FDA.
• A delay at the site can cause the sponsor to miss its reporting deadlines.
• Clear site procedures help staff recognize and escalate serious events at once.

What FDA inspectors look for

• Whether serious adverse events were reported to the sponsor immediately.
• Whether progress and final reports were submitted.
• Whether financial disclosure information was provided.

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