Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs | Guideline Explorer

Scope & Applicability

Stakeholders

4

Investigator

Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining

Clinical Investigator

Veterinarian responsible for selecting anesthetic regimens and conducting field studies

Sponsor

Entity responsible for submitting applications under section 524B

Institutional Review Board

Governs top dose in clinical studies

Regulatory Context

Attributes

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Serious and Unexpected

Criteria for adverse experiences requiring IND safety reports

Related CFR Sections (7)

21CFR812.46§ 812.46 Monitoring investigations.
(a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either securRead full regulation →
21CFR812.150§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:Read full regulation →
21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
21CFR312.66§ 312.66 Assurance of IRB review.
An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in thRead 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 →
21CFR56.108§ 56.108 IRB functions and operations.
In order to fulfill the requirements of these regulations, each IRB shall:Read full regulation →

Related Warning Letters (10)

In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
2025-12-23
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
2025-12-09
Sponsor/Investigator
Verdure Sciences, Inc.
2025-11-18
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
2025-09-30
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
2025-09-23
Clinical Investigator
Shirish M. Gadgeel, M.D.
2025-09-09
Clinical Investigator
Mark J. Savant, M.D
2025-07-15
Clinical Investigator
Peter Michael, M.D.
2025-07-01
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
2025-06-10
Bioresearch Monitoring Program
Amy Lightner, MD
2025-06-03