21 CFR 312.62
Investigator recordkeeping and record retention
21 CFR 312.62 is the regulation titled “Investigator recordkeeping and record retention” in 21 CFR Part 312, Investigational New Drug Application. Since 2021, 10 FDA warning letters have cited it.
- Letters citing it
- 10 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 312.60, in 8 letters
- Closed out
- 20% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (7 of 10). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 312.62 most often, as written in the letters.
- 2 lettersYou failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects [21 CFR 312.62(a)]
- 1 letterFailure 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 product [21 CFR…
- 1 letterFailure to prepare and maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation. [21 CFR 312.62(b)]
The regulation
Read the text of 21 CFR 312.62 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 312.62.
- 21 CFR 312.60General responsibilities of investigators8 letters cite both
- 21 CFR 50.20General requirements for informed consent3 letters cite both
- 21 CFR 312.2Applicability2 letters cite both
- 21 CFR 312.20Requirement for an IND2 letters cite both
- 21 CFR 312.66Assurance of IRB review2 letters cite both
- 21 CFR 50.23Exception from general requirements2 letters cite both
- 21 CFR 312.40General requirements for use of an investigational new drug in a clinical investigation1 letter cites both
- 21 CFR 312.57Recordkeeping and record retention1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 312.62 that FDA posted most recently.
- DrugsView Maria E. De La Torre Silva, M.D.investigational drugIssuedJul 27, 2026PostedAug 4, 2026
- BiologicsView Adnan Dahdul, MDYou failed to obtain legally effective informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR…IssuedMar 12, 2026PostedMay 26, 2026
- DrugsView Maria A. Carballosa, M.D.investigational drug (b)(4)IssuedDec 12, 2025PostedDec 23, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.