21 CFR 312.64: Investigator reports
Requires clinical investigators to give the sponsor progress reports, immediate reports of serious adverse events with causality assessment, a final report, and updated financial disclosure information through one year after the study ends.
Part 312, Investigational New Drug Application · Subpart D, Responsibilities of Sponsors and Investigators
How FDA words it
The opening lines investigators use most when they cite 312.64, from the 483s we hold.
Failure to report serious adverse events promptly to the sponsor.Most used
Recent 483s citing 312.64
- Amit G. Shah, MD · —Failure to report serious adverse events promptly to the sponsor… Apr 2, 2026
- Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se · Ocala, FloridaFailure to report non-serious adverse events to the sponsor in accordance with the… Sep 16, 2025
- Osmotica Pharmaceutical US LLC · Marietta, GeorgiaFailure to report serious adverse events promptly to the sponsor… May 2, 2025
- Form 483 · FEI 3033061128 · —Failure to report serious adverse events promptly to the sponsor… Feb 28, 2025
- Warren B. Shapiro, MD · Brooklyn, New YorkFailure to report promptly to the sponsor adverse effects that may reasonably be… May 6, 2015
The regulation text
§ 312.64 Investigator reports.
(a)Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The sponsor is required under § 312.33 to submit annual reports to FDA on the progress of the clinical investigations.
(b)Safety reports. An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported in accordance with the protocol unless there is evidence suggesting a causal relationship between the drug and the event (e.g., death from anaphylaxis). In that case, the investigator must immediately report the event to the sponsor. The investigator must record nonserious adverse events and report them to the sponsor according to the timetable for reporting specified in the protocol.
(c)Final report. An investigator shall provide the sponsor with an adequate report shortly after completion of the investigator's participation in the investigation.
(d)Financial disclosure reports. The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements as required under part 54 of this chapter. The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 63 FR 5252, Feb. 2, 1998; 67 FR 9586, Mar. 4, 2002; 75 FR 59963, Sept. 29, 2010]
Questions
What does 21 CFR 312.64 require?
Requires clinical investigators to give the sponsor progress reports, immediate reports of serious adverse events with causality assessment, a final report, and updated financial disclosure information through one year after the study ends.
How do FDA investigators word a 312.64 observation?
The most common opening is: “Failure to report serious adverse events promptly to the sponsor.”
Which sections are cited alongside 312.64?
In the same 483s, investigators most often also cite 312.60 (General responsibilities of investigators), 312.62 (Investigator recordkeeping and record retention).