Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043): References
Legislation
Quality documents
Policies
- POL-0030: Compliance and enforcement approach and inspection strategy for clinical trials of drugs involving human subjects
- Compliance and enforcement policy for health products (POL-0001)
- Policy on accessing the premises of a regulated party remotely to verify compliance (POL-0138)
Guidances
- Risk classification guide for drug good manufacturing practices observations (GUI-0023)
- Guidance document: Part C, Division 5 of the Food and Drug Regulations "drugs for clinical trials involving human subjects" (GUI-0100)
Other guidances and database
Page details
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