Clinical Precedent™ — the walkthrough CC ×

The FDA inspection record, in short videos

7 films, each a few minutes: how Clinical Precedent works, free guides read aloud with their charts, and the record for clinical research by the numbers. Every film has captions and a page of its own with the transcript.

Clinical Precedent in brief

• How Clinical Precedent works 7:11 · narrated A seven-minute narrated tour of Clinical Precedent: what the FDA inspection record shows on a clinical investigator or site, and how to read it.
• Clinical Precedent in two minutes 1:43 · narrated The walkthrough in brief: what the FDA inspection record shows on a clinical investigator or site before a sponsor signs, and how Clinical Precedent puts it in front of you.
• Before You Sign: a sponsor checks a clinical investigator’s FDA inspection history 1:58 · two voices, fictional names Two sponsor colleagues look up their lead site’s FDA inspection history before the contract is signed. A short film; every name and record in it is fictional.

The guides, narrated

• OAI, VAI and NAI: FDA inspection classifications, explained 3:19 · narrated from the guide · read the guide The free guide, narrated: what FDA’s three inspection classifications mean, why Official Action Indicated is the most serious one FDA assigns, and what usually follows an OAI.
• What happens after a BIMO inspection: the 483, the classification, and who is told 3:28 · narrated from the guide · read the guide The free guide, narrated: the steps after an FDA BIMO inspection of a clinical investigator closes, in their set order, how long each takes, and who is told what.
• Clinical investigator inspection history: what it contains, and how to read it 3:03 · narrated from the guide · read the guide The free guide, narrated: what a clinical investigator’s inspection history contains, and how a sponsor reads one before site selection.

The numbers

• FDA clinical research inspections, by the numbers 3:10 · narrated · see the statistics page The FDA inspection record for clinical research in counts: inspections by year, the three classifications and their shares, findings, warning letters and how long FDA took to issue them, and the disqualification and debarment lists.

The films also go up, as each is published there, on the Clinical Precedent YouTube channel. The pages here play our own copies and load nothing from YouTube.