Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry | Guideline Explorer

Description

This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.

Scope & Applicability

Product Classes

2

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Investigational Device

Medical device being tested in a clinical trial.; Medical devices intended for participants during the trial.

Stakeholders

4

Sponsor

Entity responsible for submitting applications under section 524B

Clinical Investigator

Veterinarian responsible for selecting anesthetic regimens and conducting field studies

CRO

Contract Research Organization responsible for sample retention; Contract Research Organization performing testing under contract

Contract Research Organization

Entity to which obligations may be transferred

Regulatory Context

Attributes

2

Critical Data

Data points that affect study results or subject protection

Quality Metrics

review of vendor performance or quality metrics

Identified Hazards

Hazards

4

Risk to Data Quality

Potential threat to trial integrity

Safety Concerns

Risks associated with the investigational product

Human Subject Protection Risk

Risks that threaten the safety of trial participants

Risks to subject protection

Safety concerns addressed by risk-based monitoring

Related CFR Sections (4)

21CFR312.52§ 312.52 Transfer of obligations to a contract research organization.
(a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. If not all obligations are transferred, the writing is required to describe each of the obligations being assumed bRead full regulation →
21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:Read full regulation →
21CFR312.50§ 312.50 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan Read full regulation →
21CFR812.40§ 812.40 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensurRead 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