Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043): Assigning an inspection rating

Once all the observations have been rated, the inspector will assign an overall rating of "C" or "NC", when applicable:

Both "C" and "NC" ratings require corrective and preventive actions (CAPAs) for cited observations.

Critical observations (risk 1)

If 1 or more observations are classified as critical (risk 1), the inspector will inform the regulated party before the exit meeting. They will be informed that this will likely result in an overall "NC" rating. This may result in additional compliance and enforcement actions.

Health Canada will ask for an action plan that outlines the corrective measures to be taken as well as the time frame for implementing these measures.

If there is a potential immediate health risk (potential injury) to a clinical trial subject or other person (as per section C.05.017 of the Regulations), the inspector will request an evaluation to confirm the risk from the Pharmaceutical Drugs Directorate (PDD) or Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Enforcement actions will be taken as required to achieve compliance in accordance with the Compliance and enforcement policy for health products (POL-0001).

Major observations (risk 2)

In most cases, the inspector will assign a "C" rating to observations classified as major (risk 2). However, the inspector could assign an "NC" rating in the following situations:

Minor observations (risk 3)

Where all observations are classified as minor (risk 3), no compliance and enforcement actions will be taken and a "C" rating will be assigned.

For more information on clinical trial inspections of drugs involving human subjects, please consult:

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