Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043) (English, HTML)

View metadata and access the original English HTML file: Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043).

Format

HTML

Access

file-only

Publisher-reported update

2022-06-07

The purpose of this guide is to help classify the level of severity of deviations noted as observations during inspections of clinical trials with drugs for human use and ensure uniformity in the assignment of ratings of observations among Inspectors of the Health Products and Food Branch (HPFB) Inspectorate.

Access original file