Guide

FDA’s clinical investigator inspection lists, explained

The Clinical Investigator Inspection List (CLIIL) is FDA’s running record of inspections of clinical investigators who conducted studies of investigational drugs, with the classification FDA assigned to each. CDER maintains the CLIIL for drug trials; CBER maintains a comparable list for biologics. They are the longest-running record of clinical investigator inspections, and the starting point of any regulatory-history check.

What the lists contain

One row per inspection, typically with:

The clinical investigator — name and, where given, title and the institution or address inspected.

The inspection dates — when the inspection began and ended.

The classification — NAI, VAI or OAI, as finally assigned by the center after review (see OAI, VAI and NAI). Where the classification was later revised, the list carries the final one.

Identifiers and notes — the center, sometimes the inspection’s reason (data audit or for-cause), and codes that vary by list and era.

What they leave out

The findings. The lists carry the classification, not what was cited. A VAI row tells you there were objectionable conditions; it does not say whether they concerned informed consent, case histories, or control of the investigational drug.

Facility identifiers. The lists are keyed by name, not by FEI number, so matching a row to a site — or two rows to the same physician who moved — is a name-matching exercise. Names drift between records; identity must be confirmed before relying on a match.

What came next — whether an OAI led to a warning letter or to disqualification proceedings.

Recent inspections. A row appears after the center has classified the inspection, weeks to months after it closed.

Other parties. Sponsors, CROs, monitors and IRBs are inspected under the same program but are not clinical investigators, so they do not appear on these lists.

How the lists fit with the rest of the record

The lists are the long view: decades of clinical investigator inspections, keyed by name, each with the classification FDA assigned. For more recent inspections FDA’s record also carries the findings cited and a facility identifier, which is what lets an inspection be tied to a site and read in detail. Neither view is complete on its own, and the two do not share identifiers, so putting them together is a matching job. Clinical Precedent does that work: its record combines the inspection and findings record since 2008 with the clinical investigator inspection lists for the years before it — CDER’s back to 1977 and CBER’s back to 1990 — matched by name where a facility identifier is not available, and always labelled as a name match.

Reading a row when you are selecting a site

A single VAI from a decade ago and three recent inspections including an OAI are different histories. The questions worth asking of any row: how long ago, how was it classified, were there other inspections, and — for anything since 2008 — what was cited. A run of NAI inspections is itself information: a clinical investigator FDA has inspected several times without objection has a record, and “never inspected” is a different answer. Where the list shows an OAI, read the findings if they are recorded, and ask the site for their responses and corrective action plans. How this fits into the whole file: clinical investigator vetting.

Questions this page answers

What is the CLIIL?

The Clinical Investigator Inspection List is CDER’s running record of FDA inspections of clinical investigators who conducted studies of investigational drugs, with the dates and the final classification (NAI, VAI or OAI) of each. CBER maintains a comparable list for biologics trials.

Does the clinical investigator inspection list show what FDA found?

No. It shows the classification, not the cited findings. For older inspections the classification is the only detail the record holds; for more recent ones, the findings can be read once the list entry is matched to the inspection it describes, which is part of what Clinical Precedent assembles.

Can I look up a clinical investigator by FEI number on the CLIIL?

Not directly: the lists are keyed by name and address, not by FEI number. Matching a list row to a facility, or two rows to the same physician, is a name match and should be confirmed before it is relied on.

How current is the clinical investigator inspection list?

A row is added after the reviewing center has classified the inspection, which is weeks to months after it closes. The newest inspections are therefore that old when they first appear, on the list and everywhere else.

Are sponsors, CROs and IRBs on the clinical investigator inspection list?

No. They are inspected under the same Bioresearch Monitoring program but are not clinical investigators, so they are not on these lists.

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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.