Risk classification guide for observations related to inspections of clinical trials of human drugs (GUI-0043): Definitions

These definitions explain how terms are used in this document. If there is a conflict with a definition in the Food and Drugs Act (Act) or its Regulations, the definition in the Act or Regulations prevails.

Adverse drug reaction (ADR): any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue) (C.05.001)

Adverse event (AE): any adverse occurrence in the health of a clinical trial subject who is administered a drug that may or may not be caused by the administration of the drug, and includes an adverse drug reaction. (incident thérapeutique) (C.05.001)

Clinical trial: an investigation in respect of a drug for use in humans that involves human subjects and is intended to:

• discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug
• identify any adverse events in respect of the drug
• study the absorption, distribution, metabolism and excretion of the drug or
• ascertain the safety or efficacy of the drug

(essai clinique) (C.05.001)

Contract research organization (CRO): a person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (organisme de recherche sous contrat) (ICH E6 1.20)

Drug: a drug for human use that is to be tested in a clinical trial. (drogue) (C.05.001)

Exit meeting: held at the end of, or subsequent to, the inspection, during which the draft inspection exit notice and overall rating (if applicable) are presented to the regulated party. (entrevue de fin d'inspection)

Good clinical practices (GCP): generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial subjects and other persons, and the good clinical practices referred to in section C.05.010. (bonnes pratiques cliniques) (C.05.001)

Import: to import a drug into Canada for the purpose of sale in a clinical trial. (importer) (C.05.001)

Inspection: monitoring and assessment against the applicable requirements of the Food and Drugs Act and its Regulations. Inspections are routinely conducted based on risk to assess compliance. (inspection)

Inspector: any person designated as an inspector under section 22 of the Food and Drugs Act. (inspecteur)

Investigator's brochure: in respect of a drug, a document containing the preclinical and clinical data on the drug that are described in paragraph C.05.005 (e). (brochure du chercheur) (C.05.001)

Label: includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package. (étiquette) (section 2 of the Food and Drugs Act)

Observation: a deficiency or deviation from Part C, Division 5 of the Regulations noted by an inspector during a clinical trial inspection that is confirmed in writing in the final inspection exit notice. The observations are classified as "critical" (risk 1), "major" (risk 2) or "minor" (risk 3). (observation)

Protocol: a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. (protocole) (C.05.001)

Qualified investigator (QI): the person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where that clinical trial site is located, and who is:

• (a) in the case of a clinical trial respecting a drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association and
• (b) in any other case, a physician and a member in good standing of a professional medical association

(chercheur qualifié)(C.05.001)

Re-assessment: a follow-up inspection for situations where the regulated party was assigned an overall compliant ("C") rating on the previous inspection but the number or type of observations contained in the previous inspection exit notice are such that corrective action is required within a timely manner. The inspection is focused on, but not restricted to, those requirements of the Act and its associated Regulations where observations were made. (réévaluation)

Re-inspection: a follow-up inspection carried out in response to the assignment of a non-compliant ("NC") rating. The inspection is focused on, but not restricted to, those regulatory requirements where observations were made. (ré-inspection)

Repeat observation: a situation where a deviation or deficiency that happens again in a later inspection (for example, re-assessment, re-inspection). This includes:

• deviations or deficiencies reported during a previous inspection that were not adequately addressed by the regulated party
• suitable corrective actions and/or preventive actions that would prevent the deviation or deficiency from recurring were not implemented

(observation répétée)

Research ethics board (REB): a body that is not affiliated with the sponsor and that:

• (a) the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being and
• (b) has at least 5 members of whom the majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act and that includes at least
  • (i) 2 members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and 1 of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline
  • (ii) 1 member knowledgeable in ethics
  • (iii) 1 member knowledgeable in Canadian laws relevant to the biomedical research to be approved
  • (iv) 1 member whose primary experience and expertise are in a non- scientific discipline and
  • (v) 1 member who is from the community or is a representative of an organization interested in the areas of research to be approved and is not affiliated with the sponsor or the site where the clinical trial is to be conducted

(comité d'éthique de la recherche) (C.05.001)

Sell: includes offer for sale, expose for sale or have in possession for sale or distribute to 1 or more persons, whether or not the distribution is made for consideration. (vente) (section 2 of the Food and Drugs Act)

Serious adverse drug reaction (SADR): an adverse drug reaction that:

• requires in-patient hospitalization or prolongation of existing hospitalization
• causes congenital malformation
• results in persistent or significant disability or incapacity
• is life-threatening or
• results in death

(réaction indésirable grave à une drogue) (C.05.001)

Serious unexpected adverse drug reaction (SUADR): a serious adverse drug reaction (SADR) that is not identified in nature, severity or frequency in the risk information set out in the investigator's brochure or on the label of the drug. (réaction indésirable grave et imprévue à une drogue) (C.05.001)

Site or trial site: the location(s) where trial-related activities are actually conducted. (lieu d'essai clinique ou lieu de l'essai) (ICH E6, 1.59)

Site management organization (SMO): an organization that manages research at clinical trial establishments. (organisme de gestion d'établissements)

Sponsor: an individual, corporate body, institution or organization that conducts a clinical trial. (promoteur) (C.05.001)