Nearly Four in Ten FDA Clinical-Research Inspections Since 2008 Ended With Findings, New Analysis Shows

Chicago, Ill., 13 October, 2026 — Of the more nearly FDA Bioresearch Monitoring (BIMO) inspections of drug and biologic clinical research conducted since 2008, 37 percent ended with at least one cited finding, and 351 were classified Official Action Indicated, the agency's most serious outcome, according to an analysis released today by Clinical Precedent, a clinical investigator vetting platform launching at clinicalprecedent.com.

The analysis, drawn from the platform's dataset of more than 6,600 findings cited against clinical investigators, sponsors, contract research organizations and institutional review boards, shows where inspections go wrong:

• General responsibilities of investigators (21 CFR 312.60), the regulation that requires an investigator to follow the protocol and protect the rights, safety and welfare of subjects, is the most cited, at 28 percent of all findings.
• Case history records (21 CFR 312.62(b)) is second, at 15 percent. Together the two account for 43 percent of findings.
• Investigational drug accountability records, assurance of IRB review, and IRB meeting minutes round out the top five.
• Since 2021, roughly one in four inspections has ended with findings, down from the long-run rate, while the share classified Official Action Indicated has held near 2.5 percent.
• 144 clinical investigators appear as disqualified on FDA's proceedings list, and FDA's debarment list names 151 individuals.

"The pattern has held for eighteen years. The findings that end careers are about protocol adherence and records, not exotic fraud," said Joshua Chapman, founder of Clinical Precedent. "A sponsor can now see whether a candidate investigator has a history of exactly those findings before the Form 1572 is signed. That is what the platform is for."

Clinical Precedent ties every inspection, finding, warning letter and disqualification record to the organization it concerns. Members look up an investigator or site by name or FEI number, read the record benchmarked against the rest of the dataset, compare finalists, screen whole rosters, search findings by Good Clinical Practice problem area, and keep a watchlist with email alerts for new FDA activity. Each vetting result exports as an audit-ready PDF for the site-selection file. A free status check, open without an account, screens any name against FDA's disqualification proceedings and debarment list.

"A clean record is not a guarantee, and a VAI is not disqualifying," said Jerry Chapman, Chief Quality Officer. "What matters is what was cited, how recently, and how the investigator responded. Those are questions a quality lead can answer from the record, and could not answer from a list."

Methodology. Counts cover FDA BIMO inspections of drug and biologic clinical research (clinical investigators, sponsors and CROs, and IRBs) with end dates from 2008 through 2026, from publicly available FDA data as processed by Clinical Precedent. Device (21 CFR Part 812) and nonclinical-laboratory inspections are excluded but under consideration for future scope. Every inspection in the dataset carries an FDA classification. Finding percentages are shares of all cited findings in scope.

Clinical Precedent reports the public record; it does not make recommendations or provide regulatory or legal advice.

Clinical Precedent is available now at clinicalprecedent.com.