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

Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043): English HTML file. From Health Canada, updated Jun 2022. View metadata, licence and the direct download on CanQuery.

Format

HTML

Access

Original download 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.

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