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

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). 2021-05-04 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidancePart CDivision 5Food and Drug RegulationsDrugs for Clinical TrialsClinical Trials Involving Human SubjectsGUI-0100 Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100)HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100/document.html Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100)HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/conformite-application-loi/bonnes-pratiques-cliniques/documents-orientation/guide-drogues-destinees-essais-cliniques-sujets-humains-gui-0100/document.html

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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