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Found 10 records similar to Notice - Publication of information about certain Clinical Trial Applications authorized by Health Canada

Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2018
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trial-application, clinical-trial-application process, clinical-trial, clinical-trial sponsors, file a clinical-trial-application, CTA, human drug clinical-trials
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 9, 2007
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials manual, clinical trial sponsors, clinical trial applications, CTA, facilitate successful filing
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  authorized investigational testing, authorized clinical-trials, release of information, medical-device investigational-testing Applications
Federal

Canada aims to reduce the risks to participants who enroll in clinical trials. Learn about clinical trial inspections and how we conduct them.

Last Updated: Apr. 28, 2021
Date Published: Oct. 28, 2016
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, inspections of clinical trials, human drugs clinical trials
Federal

This statement provides guidance to clinical trial applicants about the investigational use of marketed drugs within clinical trials in Canada.

Last Updated: Jun. 7, 2022
Date Published: Apr. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial, investigational Use-of-Marketed-Drugs, Use-of-Marketed-Drugs in clinical-trials, guidance, clinical trial applicants
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: Jan. 18, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trial site-information form, CTSI form, instructions for completing, clinical-trial sponsors
Federal

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.

Last Updated: Jun. 2, 2021
Date Published: Mar. 2, 2016
Organization: Health Canada
Formats: HTML
Keywords:  notice, clinical trial, regulatory activities, Non-eCTD Electronic-Only, clinical trial sponsors, amendements
Federal

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.

Last Updated: Jun. 2, 2021
Date Published: Mar. 12, 2009
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, quality technical requirements, chemistry and manufacturing, clinical trial applications, CTAs, Pharmaceuticals
Federal

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.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trial sponsor, institution or investigator, investigator initiated clinical-trials, commercial sponsor, investigator, regulatory-responsibilities
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Last Updated: Jun. 7, 2022
Date Published: Apr. 6, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials for COVID-19-medical-devices, list of authorized-clinical-trials
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