The FDA record behind clinical research, explained

Plain-language guides for the sponsor, CRO and quality teams that choose and oversee clinical investigators: what the regulations require, what an FDA inspection produces, and what each document on a site’s record means. Free, no account needed. New to this? Start with what clinical investigator vetting covers.

Vetting and selecting a clinical investigator

The due-diligence sequence, from the regulatory obligation to the visit — and where the inspection record fits.

• What is clinical investigator vetting? The due-diligence check on a clinical investigator’s FDA record, and why it belongs in the site-selection file.
• Clinical investigator selection What 21 CFR 312.53 and ICH E6 require, the criteria sponsors use in practice, and where the FDA record fits.
• Clinical investigator inspection history What an inspection history contains, why it is hard to assemble, and how a sponsor reads one.
• Form 1572 due diligence What to check before a clinical investigator signs: the qualification part and the record part.
• The site qualification visit What the pre-study visit covers, and the one thing it cannot confirm: the site’s inspection record.
• Sponsor responsibilities for clinical investigators The duties under 21 CFR 312.50–312.56 — and why FDA does not typically tell a sponsor when it inspects one of its clinical investigators.

Inspections and what they produce

Who FDA inspects, what the inspector examines, and the documents and classifications that follow.

• Good Clinical Practice (GCP) basics The standard FDA inspects against: each principle, the regulation that enforces it, and how often FDA cites it.
• Inside a BIMO inspection Who FDA inspects, what the inspector examines, and what NAI, VAI and OAI mean.
• What happens after a BIMO inspection The sequence from the closing meeting to a warning letter or close-out, how long it takes, and who is told at each step.
• Form FDA 483 for clinical investigators What the inspector’s observations are, how a 483 differs from the classification and a warning letter, and the 15-business-day response.
• Clinical investigator deficiencies What FDA cites most often, area by area: the regulation, what it looks like at a site, how often it is cited, and how the mix has changed.
• OAI, VAI and NAI, explained Official Action Indicated is the most serious inspection classification FDA assigns. What each means, who assigns them, and what usually follows an OAI.
• Warning letters to clinical investigators What a warning letter cites, how it relates to an OAI classification, why the sponsor usually isn’t copied, and what a sponsor does about one.
• FDA’s clinical investigator inspection lists What the CDER and CBER lists (CLIIL) contain, what they leave out, and how to read a classification on them.

Status and enforcement

The mechanisms that take a clinical investigator out of research, and the letters that open them.

• Debarment vs. disqualification Two different mechanisms, routinely confused: triggers, processes and what each means for a sponsor.
• NIDPOE letters, explained How FDA opens disqualification proceedings against a clinical investigator, and how they end.
• NOOH letters, explained The second step in disqualification: what the Notice of Opportunity for Hearing says, and what a clinical investigator can do.

Tools and numbers

Two things you can do now without an account, and the output a subscriber files.

• Free clinical investigator status check Screen a name against FDA’s disqualification proceedings and debarment list, and see whether an inspection record exists.
• FDA clinical investigator inspection statistics Inspections by year and classification, warning letters by year, the most cited regulations, and the disqualification and debarment totals.
• A sample vet report The dated, audit-ready snapshot a subscriber files — on a fictional record.

Announcements and articles from the team are on the News page.

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