Guide

FDA inspections of clinical investigators: what the BIMO program covers

FDA inspects clinical investigators, sponsors, CROs and IRBs through its Bioresearch Monitoring (BIMO) program, the inspection program for the conduct of research itself: not the factory where a drug is made, but the trials that support it. Its purpose is twofold — protect the rights, safety and welfare of research subjects, and verify the integrity of the data submitted to FDA.

Who gets inspected

BIMO reaches every party in the research chain: clinical investigators (the physicians running trials — the largest share of inspections by far), sponsors, CROs and monitors, institutional review boards (IRBs), and nonclinical (GLP) laboratories and bioequivalence facilities. Clinical Precedent covers the drug and biologic clinical-research record: clinical investigators, sponsors/CROs and IRBs.

Who FDA inspected: drug and biologic clinical research, fiscal year 2024 Inspections on record for fiscal year 2024, domestic and foreign, by who was inspected and whether the trial was of a drug or a biologic.

Clinical investigators

546 · Drugs 416 · Biologics 130

Institutional review boards (IRBs)

88 · Drugs 57 · Biologics 31

Sponsors and CROs

82 · Drugs 74 · Biologics 8

Sponsor-investigators

10 · Drugs 6 · Biologics 4

Clinical investigators: 546, Drugs 416, Biologics 130. Institutional review boards (IRBs): 88, Drugs 57, Biologics 31. Sponsors and CROs: 82, Drugs 74, Biologics 8. Sponsor-investigators: 10, Drugs 6, Biologics 4.

Drug and biologic clinical research only. Inspections for device and veterinary trials, and FDA’s nonclinical laboratory, bioequivalence and postmarketing inspections, are not counted. Each inspection is counted in the fiscal year FDA assigns it. Yearly totals are in the inspection statistics; those also include a few inspections that are not of these four kinds.

Why an inspection happens

Most clinical investigator inspections are routine: assigned while FDA reviews a marketing application, typically at sites that contributed significant data to a pivotal trial. How many subjects a site enrolled, how its data compare with other sites, and its inspection history are among the factors FDA weighs in choosing them. The rest are for-cause inspections, which look into possible violations: prompted by a complaint from a study participant or staff member, a report from a sponsor or IRB, or a referral within FDA.

What the inspector examines

Informed consent — whether every subject consented properly, on the IRB-approved form, before study procedures began.

Conducting the study — eligibility, visit windows, dosing, required assessments; deviations and how they were handled and reported.

Source records vs. submitted data — whether the case report forms match the medical records; whether records are adequate, accurate and attributable.

Control of the investigational drug — receipt, storage, dispensing and return.

Supervision and delegation — whether the clinical investigator actually supervised the people the study tasks were delegated to.

IRB oversight — approvals in place before and during the study, and required reports made.

How an inspection ends

If the inspector observes objectionable conditions, the clinical investigator receives a Form FDA 483 — a written list of observations — at the close of the inspection. Every inspection, with or without a 483, is then classified by the reviewing center:

NAI No Action Indicated. No objectionable conditions or practices were found, or those found do not justify further action. In some cases, minor issues may have been pointed out but remediated to the satisfaction of the FDA prior to the close of the inspection.

VAI Voluntary Action Indicated. Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action; correction is left to the clinical investigator. The most common classification after NAI — and the classification where reading the actual findings matters most, because VAI spans everything from paperwork gaps to near-miss serious problems.

OAI Official Action Indicated. The most serious inspection classification FDA assigns: objectionable conditions were found that FDA considers significant enough that correction cannot be left to the clinical investigator and regulatory or administrative action is indicated. Often it leads eventually to a warning letter, and for repeated or deliberate violations it can lead to a NIDPOE letter opening disqualification proceedings.

That escalation ladder — findings, classification, warning letter, proceedings — is why clinical investigator vetting reads the whole record rather than a single list: each rung tells you something different about a site, and the most serious history lives on the rungs a simple lookup misses.

Questions this page answers

What is an FDA clinical trial inspection?

It is an inspection FDA conducts under its Bioresearch Monitoring (BIMO) program of a party involved in clinical research: a clinical investigator, a sponsor, a CRO or monitor, or an institutional review board. Its purpose is twofold: to protect the rights, safety and welfare of research subjects, and to verify the integrity of the data submitted to FDA.

Who does FDA inspect under the BIMO program?

Every party in the research chain: clinical investigators, who account for the largest share of inspections by far; sponsors, CROs and monitors; institutional review boards; and nonclinical laboratories and bioequivalence facilities. Clinical Precedent covers the drug and biologic clinical-research record: clinical investigators, sponsors and CROs, and IRBs.

Why does FDA inspect a clinical investigator?

Most clinical investigator inspections are routine: assigned while FDA reviews a marketing application, typically at sites that contributed significant data to a pivotal trial. The rest are for-cause inspections, which look into possible violations and are prompted by a complaint, a report from a sponsor or IRB, or a referral within FDA.

What does the inspector examine at a clinical investigator inspection?

Informed consent, how the study was conducted against the protocol, whether the submitted data match the source records, control of the investigational drug, the clinical investigator’s supervision of delegated tasks, and IRB oversight.

How does a BIMO inspection end?

If the inspector observed objectionable conditions, the clinical investigator receives a Form FDA 483 listing them at the close of the inspection. Every inspection, with or without a 483, is then classified by the reviewing center as NAI, VAI or OAI, the most serious inspection classification FDA assigns.

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About this guide. It is educational, and it is not regulatory or legal advice. The authorities are the Code of Federal Regulations, FDA’s guidance and ICH E6; where this guide and those sources differ, the sources govern.