Preview of Clinical Precedent (GCP guide). This is the opening of the members' guide; the rest of it is for subscribers.
Guide
Reading the data & weighing a clinical investigator
What this service does: it compiles
and compares the FDA inspection record for clinical research.
It is one input for your decision. It does not recommend clinical investigators,
rank them, or assess their therapeutic expertise, site capabilities, or enrollment
record. It provides thoughtful discussion on the evaluation process.
New to Clinical Precedent? Watch the seven-minute walkthrough — a narrated tour of what the record shows and how to read it.
How serious are the findings?
FDA assigns every inspection a classification — the primary severity signal, color-coded throughout Clinical Precedent:
| Classification | What it means |
|---|---|
| OAI Official Action Indicated | Most serious. Objectionable conditions that may warrant regulatory or administrative action; often (not always) followed by a warning letter — see the enforcement monitor for how often, and how fast. |
| VAI Voluntary Action Indicated | Objectionable conditions were found, but correction is left to the site. Read the specific findings and ask the site for its responses and corrective action plans. |
| NAI No Action Indicated | No objectionable conditions were found. |
Beyond the classification, weigh how many findings there were, which regulations were cited (informed-consent and subject-protection problems tend to be weightier than recordkeeping), and whether a warning letter followed.
Other sections on this page, available to subscribers, cover:
- Interpreting results
- Evaluating a clinical investigator’s findings
- Fundamentals of Good Clinical Practice (GCP)