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