21 CFR 312.62: Investigator recordkeeping and record retention
Requires clinical investigators to keep accurate records of investigational drug disposition and complete case histories, including documented informed consent, and to retain them until two years after marketing approval or after discontinuation and FDA notification.
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 312.62, from the 483s we hold.
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.Most used
Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.312.62(b)
Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation.312.62(b)
Cited over time
483s citing 312.62, by yearMost citations in 2025. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2025.
Recent 483s citing 312.62
- Form 483 · FEI 3042366712 · Phoenix, ArizonaFailure to prepare or maintain adequate and accurate case histories with respect to… Mar 13, 2026
- Prof. Bernardo Leon Rapoport · Johannesburg, South AfricaFailure to prepare or maintain adequate and accurate case histories with respect to… Jan 29, 2026
- Lan Luo, M.D. Ocala Cardiovascular Research, 2801 Se · Ocala, FloridaInvestigational drug disposition records are not adequate with respect to quantity… Sep 16, 2025
- Frederick J. Raal, FCP(SA), PhD, MD · Johannesburg, Gauteng, South AfricaFailure to prepare or maintain accurate case histories with respect to observations… Sep 4, 2025
- Evaric Pharmaceuticals Inc · HAUPPAUGE, New YorkInvestigational drug disposition records are not adequate with respect to dates,… May 16, 2025
The regulation text
§ 312.62 Investigator recordkeeping and record retention.
(a)Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. If the investigation is terminated, suspended, discontinued, or completed, the investigator shall return the unused supplies of the drug to the sponsor, or otherwise provide for disposition of the unused supplies of the drug under § 312.59.
(b)Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.
(c)Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 61 FR 57280, Nov. 5, 1996; 67 FR 9586, Mar. 4, 2002]
Questions
What does 21 CFR 312.62 require?
Requires clinical investigators to keep accurate records of investigational drug disposition and complete case histories, including documented informed consent, and to retain them until two years after marketing approval or after discontinuation and FDA notification.
How do FDA investigators word a 312.62 observation?
The most common opening is: “Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.”
Which sections are cited alongside 312.62?
In the same 483s, investigators most often also cite 312.60 (General responsibilities of investigators), 312.66 (Assurance of IRB review), 50.20 (General requirements for informed consent), 50.23 (Exception from general requirements).