Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100)

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

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Title (French) Document d’orientation : Titre 5 de la partie C du Règlement sur les aliments et drogues « Drogues destinées aux essais cliniques sur des sujets humains » (GUI-0100)
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Open Canada Date Published 2019-08-20 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["Orientation", "Partie C", "Titre 5", "Règlement sur les aliments et drogues", "Médicaments pour essais cliniques", "essais cliniques sur des sujets humains", "GUI-0100"], "en": ["Guidance", "Part C", "Division 5", "Food and Drug Regulations", "Drugs for Clinical Trials", "Clinical Trials Involving Human Subjects", "GUI-0100"]}
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