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Found 10 records similar to Clinical Trials Database (CTD)

Federal

The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.

Last Updated: Jun. 1, 2021
Date Published: Jun. 29, 2016
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, clinical trial, clinical trial applications, Food and Drugs Act, Food and Drug Regulations, human clinical trials, regulatory obligations, du+H36gs for clinical trials involving human subjects
Federal

Guidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the requirements of the protocol, which has been authorized by Health Canada and approved by REB(s).

Last Updated: Apr. 7, 2020
Date Published: Mar. 23, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19 pandemic, drugs for clinical trials involving human subjects, Research Ethics Board (REB).
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. 2, 2021
Date Published: May 9, 2007
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials manual, human clinical trials, regulatory obligations, dugs for clinical trials involving human subjects
Federal

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

Last Updated: Jul. 24, 2020
Date Published: Apr. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Coronavirus, COVID-19, pandemic, clinical trial for COVID-19 medical devices, authorized clinical trials
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

Health Canada is issuing this guidance for clinical trials in type 2 diabetes to provide clarification on the interpretation of the Canadian Diabetes Association Clinical Practice Guidelines (CDA-CPG)Footnote1 in relation to clinical trial applications under Part C, Division 5 of the Food and Drug Regulations.

Last Updated: Jun. 2, 2021
Date Published: Sep. 4, 2007
Organization: Health Canada
Formats: HTML
Keywords:  guidance for industry, standards, clinical trials in type 2 diabetes, Canadian Diabetes Association Clinical Practice Guidelines, CDA-CPG, Food and drug Regulations
Federal

Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.

Last Updated: May 28, 2021
Date Published: Apr. 28, 2021
Organization: Health Canada
Formats: HTML
Keywords:  guidance, document, Interim Order, coronavirus, COVID-19, clinical trial, drug, regulations, clinical trial phases
Federal

The pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format concluded on August 31, 2019. Health Canada is pleased to announce that the pilot was successful. Therefore, implementation of Clinical Trials regulatory activities in eCTD format will begin immediately.

Last Updated: Jun. 2, 2021
Date Published: Feb. 19, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Notice, implementation of eCTD, electronic common technical document, clinical trial regulatory activities
Federal

The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory requirements as set out in Division 5 – Clinical Trial Applications of the Food and Drug Regulations.

Last Updated: Jun. 2, 2021
Date Published: Aug. 21, 2015
Organization: Health Canada
Formats: HTML
Keywords:  guidance document, clinical trial applications, sponsors, cell therapy products, cell therapy products, in humans, federal regulatory requirements, Food and Drug Regulations
Federal

Learn about the outcomes of the public consultations on the COVID-19 clinical trials Interim Order and clinical trials records retention.

Last Updated: May 28, 2021
Date Published: Apr. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, clinical trials, Interim Order, clinical trials records retention, consultation report
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