An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator pursuant to § 312.62 . The investigator is not required to divulge subject names unless the records of particular individuals require a more detailed study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained.
21 CFR Part 312 · Investigational New Drug Application
§ 312.68 Inspection of investigator's records and reports
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 312.68
Form FDA 483 observations citing this section, fiscal years 2010–2025 (Bioresearch Monitoring).
- FDA access to clinical investigator records 9
FDA guidance that cites § 312.68
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators 5 Feb 2025
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers 1 Oct 2024
- Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs draft 16 Sept 2024
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations 22 Dec 2023
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors 15 Aug 2023
- Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry 19 Jul 2018
- Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors 15 Dec 2016
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators draft 15 May 2015
- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry 23 Oct 2009
Amendment history
Federal Register documents that created or amended this section.
- 52 FR 8831 19 Mar 1987