#Mail pilot 2.3.1 review trial#

These studies are often important for optimizing the drug's use. These are intended to gather the additional information about the clinical efficacy and safety under the proposed conditions of use.Īll studies performed within the approved indication after the drug has been approved by the regulator for the market. If a new indication for a marketed drug is to be investigated, then those clinical trials may generally be considered Phase II trials.Ĭontrolled or uncontrolled trials conducted after preliminary evidence suggesting efficacy of the drug has been demonstrated.

Phase I trials are generally conducted in healthy volunteers, but may be conducted in patients when administration of the drug to healthy volunteers is not ethical.Ĭlinical 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 the drug. Drug interaction studies are usually considered as Phase I trials regardless of when they are conducted during drug development. In respect of a drug, a document containing the nonclinical and clinical data on the drug that are described in section C.05.005(e) of theĬlinical trials designed to determine the pharmacokinetics/pharmacological actions of the drug and the side effects associated with increasing doses.

#Mail pilot 2.3.1 review trial#

For such trials, the institution or investigator is considered to be the sponsor of the trial and must fulfill all the regulatory obligations of the sponsor as outlined in the Institution/Investigator-initiated Clinical TrialĪ clinical trial that is initiated and conducted by an institution or an individual investigator. All other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial.The risks and anticipated benefits to his or her health arising from participation in the clinical trial and.Individual investigators at the clinical trial sites in Canada may serve as Canadian Importers. 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. To import a drug into Canada for the purpose of sale in a clinical trial. 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 the The location where trial-related activities are actually conducted.įor the purpose of the Clinical Trial Site Information Form, this is defined as the date when the clinical trial site will be ready to enrol patients in the clinical trialĪ drug for human use that is to be tested in a clinical trial. Health Canada typically issues a No Objection Letter in instances where no objection has been raised.Īn 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. Quality Overall Summary - Chemical Entities (Clinical Trial Applications)Īny noxious and unintended response to a drug that is caused by the administration of any dose of the drug.Īny 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.įor the purposes of this document, an authorized clinical trial is one that has been filed with Health Canada and has not received an objection from Health Canada within 30 days. Quality Information Summary - Radiopharmaceuticals Quality Information Summary - Positron-Emitting Radiopharmaceuticals Protocol Safety and Efficacy Assessment Template - Clinical Trial Application International Conference on Harmonisation Health Products and Food Branch Inspectorate Biologics and Genetic Therapies DirectorateĬouncil for International Organizations of Medical Sciences