Adverse Drug Reaction
Biologics and Genetic Therapies Directorate
Clinical Trial Application
Clinical Trial Application - Amendment
Common Technical Document
Drug Identification Number
Good Clinical Practice
Health Products and Food Branch Inspectorate
International Conference on Harmonisation
Notice of Compliance
No Objection Letter
Not Satisfactory Notice
Protocol Safety and Efficacy Assessment Template - Clinical Trial Application
Quality Overall Summary-Chemical Entities (Clinical Trial Applications)
Research Ethics Board
Therapeutic Products Directorate
Adverse Drug Reaction
Any noxious and unintended response to a drug that is caused by the administration of any dose of the drug.
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.
Biologics (biological products)
Encompass most drugs whose manufacture involves purification from biological sources such as human or animal tissue or body fluids, or micro-organisms, including those derived using biotechnology. Typical examples include blood and blood products, vaccines, biological response modifiers (growth factors, cytokines, etc.) protein hormones, gene therapy vectors, and cell-based products.
Regulation of these products entails special considerations not applicable to traditional small molecular weight chemical drugs relating to the inherent variability associated with isolation from, or manufacturing in, living organisms, the risk of adventitious agents, and the labile nature of the final product. For this reason, in Canada, biologics are defined by their listing on Schedule D to the Food and Drugs Act which has both individual and class-type entries.
Generally excludes drugs that are chemically synthesized even if they are biological in nature (e.g. small peptides) unless they fit a listing in Schedule D, e.g., "immunizing agents".
Request for clarification issued during screening and review of an application.
An investigation in respect of a drug for use in humans that involves human subjects and that 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.
Comparative Bioavailability Studies
For the purpose of this document, studies comparing the pharmacokinetics of two drug formulations in healthy adult volunteers.
Date of Commencement of a Clinical Trial
For the purpose of the Clinical Trial Site Information Form, this is defined as the date when the clinical trial site will be ready to enroll patients in the clinical trial.
For the purpose of this document, a drug for human use that is to be tested in a clinical trial.
Good Clinical Practices
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 of Division 5 of the
Food and Drug Regulations
To import a drug into Canada for the purpose of sale in a clinical trial.
The sponsor or person designated by the sponsor who is responsible for the import of the drug into Canada for the purpose of sale in a clinical trial. Individual investigators at the clinical trial sites in Canada may serve as Canadian Importers.
Written informed consent, given in accordance with the applicable laws governing consent is obtained from every person before that person participates in a clinical trial but only after that person has been informed of:
- the risks and anticipated benefits to his or her health arising from participation in the clinical trial; and
- all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial.
In respect of a drug, a document containing the preclinical and clinical data on the drug that are described in section
of Division 5 of the
Food and Drug Regulations
Initial safety studies on a new drug, including the first administration of the drug into humans, usually conducted in healthy volunteers. These trials may be conducted in patients when administration of the drug to healthy volunteers is not ethical. Phase I trials are designed mainly to determine the pharmacological actions of the drug and the side effects associated with increasing doses. Pharmacokinetic as well as drug-drug interaction studies are usually considered as Phase I trials regardless of when they are conducted during drug development as these are generally conducted in healthy volunteers. Phase I trials also include trials in which new drugs are used as research tools to explore biological phenomena or disease processes.
Clinical trials to evaluate the efficacy of the drug in patients with medical conditions to be treated, diagnosed or prevented and to determine the side effects and risks associated with drug. If a new indication for a marketed drug is to be investigated, then those clinical trials may generally be considered Phase
Controlled or uncontrolled trials conducted after preliminary evidence suggesting efficacy of the drug has been demonstrated. These are intended to gather the additional information about efficacy and safety that is needed for further risk/benefit assessment of the drug. In this phase, clinical trials are also conducted in special patient populations (e.g., renal failure patients), or under special conditions dictated by the nature of the drug and disease.
All studies performed after the drug has been authorized by the regulator for the market, and related to the authorized indication. These studies are often important for optimizing the drug's use. They may be of any type but must have valid scientific objectives. Commonly conducted studies include safety studies and studies designed to support use under the authorized indication such as mortality and morbidity studies, or epidemiological studies.
A document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial.
The person responsible to the sponsor for the conduct of the clinical trial at the 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
- 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
- in any other case a physician and a member in good standing of a professional medical association.
Research Ethics Board
A body that is not affiliated with the sponsor, and
- 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
- that has at least five members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration Act, that is composed of both men and women and that includes at least:
- two members whose primary experience and expertise are in scientific discipline, who have broad experience in the methods and areas of research to be approved and one 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,
- one member knowledgeable in ethics,
- one member knowledgeable in Canadian laws relevant to the biomedical research to be approved,
- one member whose primary experience and expertise are in a non-scientific discipline, and
- one member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted.
Senior Medical or Scientific Officer
A scientific or medical officer residing in Canada, representing the sponsor, who is responsible for providing an attestation with respect to the Clinical Trial Application/Amendment at the time of filing, as outlined in Appendix 3 of the Drug Submission Application Form (
Serious Adverse Drug Reaction
An adverse drug reaction that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death.
Serious Unexpected Adverse Drug Reaction
A serious adverse drug reaction 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.
An individual, corporate body, institution or organization that conducts a clinical trial.