Guidance for clinical trials with decentralized elements: Definitions, resources, contact us
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Definitions
The following definitions explain how terms are used in this guidance.
Most of the definitions are from the Food and Drugs Act or Food and Drugs Regulations. Other definitions are from Health Canada or International Council for Harmonisation (ICH) guidance documents. The ICH guidances are indicated as follows:
- General Considerations for Clinical Trials (ICH E8)
- Guideline for Good Clinical Practice: Harmonized Guideline (ICH E6)
If there’s a conflict with how terms are defined in the legislation and a guidance document, the definition in the act or regulations prevails.
- Adverse drug reaction (ADR):
- Any adverse and unintended occurrence in the health of a participant who is administered a drug in a clinical trial, where there are reasonable grounds to believe the occurrence could be a noxious response to a dose.
- Adverse event (AE):
- Any adverse occurrence in the health of a participant who is administered a drug in a clinical trial that may or may not be caused by this drug. It includes an adverse drug reaction.
- Agreement:
- A document (or set) detailing any arrangements on delegating, transferring, distributing or sharing activities and, if appropriate, on financial matters between 2 or more parties. The agreement could be in the form of a contract. The protocol may serve as the basis of an agreement. (ICH E6)
- Clinical trial:
-
An investigation related to a drug for use in humans that involves human subjects. The trial is held to:
-
- discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug
- identify any adverse events related to the drug
- study the absorption, distribution, metabolism and excretion of the drug or
- ascertain the safety or efficacy of the drug
This definition is consistent with the glossary in ICH E6.
- Clinical trial site:
- Includes a main location, where the investigator conducts a clinical trial and oversees the conduct of the clinical trial at other locations, if any, that are remote from the main location.
- Computerized systems:
- Digital systems used to create, process, store or manage clinical trial data, such as electronic data capture systems and trial databases.
- Digital health technology:
- Participant‑facing or remote data collection tools, such as wearables, sensors and mobile apps.
- Drug:
- A drug for human use that’s to be tested in a clinical trial.
For the purposes of this guidance, “drug” doesn’t include natural health products within the meaning of the Natural Health Products Regulations.
- Good clinical practices (GCP):
- Generally accepted clinical practices that are designed to help protect the rights, safety and well-being of clinical trial participants and other persons, and ensure the results are reliable. Outlined in the regulations and detailed in the ICH E6 guideline.
- Participant:
- A person who participates in a clinical trial.
- Protocol:
- A document describing the objectives, design, methodology, study population, statistical considerations and organization of a clinical trial.
Appendix B of the ICH E6 guideline describes the information found in a protocol.
- Qualified investigator (QI):
- Person responsible to the sponsor for the conduct of the clinical trial at a clinical trial site.
Under the 2026 interim policy, a “qualified investigator” may be:
- a physician or dentist who is authorized under the regulations to act as a qualified investigator
- an individual who has the education, training and experience required to conduct the clinical trial in accordance with regulatory requirements, despite not meeting the requirement to be a physician or dentist as outlined in the definition of qualified investigator in C.05.001 of the regulations
In clinical trials where the investigator is not a physician or dentist, medical decisions about the trial that are outside the licensed scope of practice of the investigator must be made by a qualified physician or dentist on the clinical trial team. The physician or dentist is:
- licensed to practise in the province or territory where the site is located
- responsible for medical oversight and participant care, including medical decisions related to the trial
- Research ethics board (REB):
- A body that isn’t affiliated with the sponsor.
The REB’s principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects to ensure their rights, safety and well-being are protected.
The REB is to be composed as follows:
- at least 5 members (both men and women), most of whom are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act
- includes at least:
- 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 concerns a drug to be used for dental purposes only, is from a medical or dental discipline
- 1 member with knowledge in ethics
- 1 member with knowledge in Canadian laws relevant to the biomedical research to be approved
- 1 member whose primary experience and expertise are in a non-scientific discipline
- 1 member who is from the community or represents an organization interested in the areas of research to be approved and isn’t affiliated with the sponsor or the site where the clinical trial is to be conducted
- Serious adverse drug reaction (SADR):
-
An adverse drug reaction that:
-
- requires in-patient hospitalization or a prolonged stay in hospital
- causes congenital malformation
- results in persistent or significant disability or incapacity
- is life-threatening
- results in death or
- requires medical intervention to prevent any of those outcomes
- Serious unexpected adverse drug reaction (SUADR):
- A serious adverse drug reaction that’s not identified in nature, severity or frequency in the risk information set out in the investigator's brochure or equivalent document or on the product label.
- Suspected unexpected serious adverse reaction (SUSAR):
- Term used to identify serious adverse reactions that require reporting to a regulatory authority.
- Service provider:
- A person or organization (commercial, academic or other) providing a service used by either the sponsor or the investigator to fulfill trial-related activities.
- Software as a medical device (SaMD):
- Software intended to be used for 1 or more medical purposes that perform these purposes without being part of a hardware medical device.
- Sponsor:
-
A person (would also include an organization) who:
-
- conducts a clinical trial solely or in combination with other persons and
- takes responsibility for the overall conduct of a clinical trial
- Standard operating procedure (SOP):
- Detailed, documented instructions to achieve uniformity of the performance of a specific activity. (ICH E6, glossary).
Resources
Legislation
Health Canada
Branches:
Web pages:
- Drug products
- Health Canada publishes guidance on clinical trials with decentralized elements: Notice
Guidance documents:
- Guidance document for clinical trial sponsors: Clinical trial applications
- Drugs for clinical trials involving human subjects (GUI-0100)
Policies:
- Policy on individual(s) accompanying a health products inspector (POL-0141)
- Policy on accessing the premises of a regulated party remotely to verify compliance (POL-0138)
- Policy on collection and retention of records related to health product compliance and enforcement (POL-0140)
- Compliance and enforcement approach and inspection strategy for clinical trials of drugs involving human subjects (POL-0030)
Government of Canada agencies
- Tri-agency research data management policy
- Tri-council policy statement: Ethical conduct for research involving humans – TCPS 2 (2022)
- Canadian Core Data for Interoperability (CACDI) (Canadian Institute for Health Information, CIHI)
International Council for Harmonisation (ICH)
- International Council for Harmonisation
- Guideline for good clinical practice E6(R3)
- General considerations for clinical studies E8(R1)
Contact us
Pharmaceutical Drugs Directorate (PDD)
Office of Clinical Trials
Pharmaceutical Drugs Directorate
5th Fl, Holland Cross, Tower B
Address locator: 3105A
1600 Scott St
Ottawa ON K1A 0K9
Fax: 613-946-7996
General enquiries: OCT_BEC_Enquiries@hc-sc.gc.ca
Clinical trial notifications: OCT_BEC_CTA-N-DEC@hc-sc.gc.ca
Clinical trial site information forms: clinical.trials.site@hc-sc.gc.ca
Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
100 Eglantine Dr
Address locator: 0601C
Ottawa ON K1A 0K9
Fax: 613-946-9520
General enquiries: BRDD.ORA@hc-sc.gc.ca
Clinical trial notifications: brdd.ctan-ndec.dmbr@hc-sc.gc.ca
Clinical trial site information forms: brdd.ctsi-filec.dmbr@hc-sc.gc.ca
Regulatory Operations and Enforcement
Clinical Trial Compliance Program: GCP_BPC@hc-sc.gc.ca