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Found 10 records similar to Notice - Publication of information about certain Clinical Trial Applications authorized by Health Canada
Depending on the type of clinical trial, sponsors may be required to file a Clinical Trial Application (CTA) for human drug clinical trials. Instances where a CTA must be filed are summarized in the chart below.
This manual is based on Health Canada's Guidance for Clinical Trial Sponsors: Clinical Trial Applications and other applicable guidance documents. It is designed to provide tools and relevant links in order to facilitate the successful filing of a Clinical Trial Application (CTA) to Health Canada.
The purpose of this Notice is to communicate that, effective immediately, Health Canada will begin releasing certain information about authorized Investigational Testing (clinical trials) involving the use of medical devices in patients.
Canada aims to reduce the risks to participants who enroll in clinical trials. Learn about clinical trial inspections and how we conduct them.
This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada.
The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-Only" Format
This Notice serves as a revision to the Release of Electronic Specifications for Clinical Trial Applications and Amendments filed in accordance with Guidance Document for Clinical Trail Sponsors: Clinical Trial Applications.
To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical requirements for CTAs pursuant to Division C.05 of the Food and Drug Regulations.
This refers to the situation where a clinical trial is not initiated by a commercial sponsor. In this case, the institution / investigator assumes the regulatory responsibilities of a clinical trial sponsor.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.