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

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.

Data and Resources

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Agreement Required
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Redistribution Allowed
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Title (French) Classification des observations relevées au cours des inspections des essais cliniques
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
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Data Dictionary
Open Canada Date Published 2017-05-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["Classification des observations", "inspections", "essais cliniques", "GUIDE-0043."], "en": ["Classification of observations", "inspections", "clinical trials", "GUIDE-0043."]}
Open Canada Collection publication
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