Description

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.

Resources

Name	Format	Description	Link
Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/classification-observations-conduct-inspections-clinical-trials-guide-0043.html
Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/bonnes-pratiques-cliniques/documents-orientation/classification-observations-cours-inspections-essais-cliniques-0043.html

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