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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.
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).
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 table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
Canada aims to reduce the risks to participants who enroll in clinical trials. Learn about clinical trial inspections and how we conduct them.
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.
Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.
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.
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.
Learn about the outcomes of the public consultations on the COVID-19 clinical trials Interim Order and clinical trials records retention.