Clinical investigator inspection history: what it contains, and how to read it
The free guide, narrated: what a clinical investigator’s inspection history contains, and how a sponsor reads one before site selection.
Transcript
Clinical investigator inspection history: how to read one.
A clinical investigator's inspection history is the record of FDA's inspections of that physician and their site: when each inspection took place, how FDA classified it, which regulations FDA cited, and whether anything followed: a warning letter, or a disqualification proceeding.
It is the part of a clinical investigator's qualifications that does not appear on a CV, and one that comes up at the site qualification visit only if the sponsor asks for it.
An inspection history does not include the Form FDA 483 the inspector left with the clinical investigator, or the clinical investigator's response to it; those stay with the site. And it does not say which study an inspection concerned.
No history is not a clean history. FDA inspects a small share of clinical investigators. A clinical investigator with no inspections has not been tested; one with a No Action Indicated inspection has been. They are different answers, and the site-selection file should say which one it is.
How to read one.
Recency: a newer inspection says more about current practice than an old one.
The findings, not only the classification: two Voluntary Action Indicated inspections can describe very different sites.
Repetition: one inspection is a snapshot. The same finding at two inspections is a pattern.
The trajectory: a VAI followed by an NAI shows a site that corrected what was found. An NAI followed by an OAI, Official Action Indicated, shows the opposite.
The response: for any VAI or OAI, ask the site for the 483 and their responses and corrective action plans.
And context: findings are common in clinical research; most inspections that cite any are classified VAI. What matters is whether this record is typical of the field, better or worse.
The check many selections run is for warning letters, disqualification and debarment. Those are the rare endings; the inspection history is everything before them, and it is where most of the information is.
Reading it is the first step of clinical investigator vetting, and it is best done before the site qualification visit, so that the visit can ask about what the record shows.
When a history shows something that causes concern for the sponsor, the options are the usual three: ask the site for their responses and corrective action plans, visit the site before signing, or choose a site without this history.
The history is one input. It does not measure therapeutic expertise, enrollment or the site's capabilities, and it does not make the decision.
The whole guide is free to read, with no account, at clinicalprecedent.com.