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

There are 3 levels of risks for observations:

  1. Critical (risk 1)
    • describes a situation that results in fatal, life-threatening or unsafe conditions for clinical trial subjects or where the integrity of the trial data is compromised
    • presents an immediate or latent undue risk to the rights, health and safety of trial subjects
    • may also refer to trials that are not authorized, adulteration, misrepresentation and falsification of records
  2. Major (risk 2)
    • describes a situation where a marked deviation or deficiency, other than a critical one, may result in undue health risks for the clinical trial subjects or in other persons and/or could invalidate the data
  3. Minor (risk 3)
    • describes a situation that is not classified as critical or major, but indicates a deficiency and/or deviation from Part C, Division 5 of the Regulations

Observations in this guidance document have a particular risk rating. However, please note that we may upgrade or downgrade the risk rating depending on the context, nature/severity and reoccurrence of the deficiencies or deviations.

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