Description
This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biological products. This guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new drug application (IND) regulations) and describes how to complete the Statement of Investigator (Form FDA 1572).
Scope & Applicability
Product Classes
2Requires analytical comparability per ICH Q5E
Subject of expanded access submissions.
Stakeholders
5Body responsible for review and approval of clinical investigation
facilitate discussions between a prospective subject and an investigator; Responsible for conducting research and providing informed consent
Governs top dose in clinical studies
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Entity responsible for submitting applications under section 524B
Identified Hazards
Hazards
1Risks and side effects of the drug described in the brochure
Related CFR Sections (4)
- 21CFR56.105§ 56.105 Waiver of IRB requirement.
On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these reRead full regulation →
- 21CFR312.120§ 312.120 Foreign clinical studies not conducted under an IND.
(a) Acceptance of studies.Read full regulation →
- 21CFR312.10§ 312.10 Waivers.
(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain Read full regulation →
- 21CFR312.53§ 312.53 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.Read full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
See Also (8)
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBs (Status: Final)
- Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical Investigators (Status: Final)
- Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (Status: Final)
- Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Sponsor - Investigator - IRB Interrelationship: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Non-local IRB Review : Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)