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:

• "C" (Compliant): the regulated party has demonstrated that the activities it conducts are in compliance with the Food and Drugs Act (Act) and its Regulations
• "NC" (Non-compliant): the regulated party has not demonstrated that the activities it conducts are in compliance with the Act and its Regulations

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:

• the nature and/or extent of the major observations indicate that the clinical trial is not being conducted with sufficient controls
• repetition of most major observations reported during previous inspections, indicating the corrective actions submitted were not implemented or adequate preventive actions were not put in place in a timely manner to avoid recurrence of these deviations

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.