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

Name: Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

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.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2022-06-07

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

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

Related open data

Health Canada