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Found 10 records similar to About inspections of clinical trials for human drugs

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

Clinical trials can be an important treatment option. However, like all drugs, the drugs used in clinical trials have possible benefits and risks. There is often less information about the safety and efficacy of a drug being studied in a clinical trial than for an authorized drug.

Last Updated: Jun. 7, 2022
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, clinical-trials and drug-safety, drugs used-in clinical-trials, possible benefits-and-risks, dug safety-and-efficacy, authorized drug
Federal

This Notice serves to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) authorized as of April 1, 2013, for the study of drugs in patients.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  publication of information, information about clinical-trial-applications, clinical trial applications, CTAs, clinical trial sponsors
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

This document provides the results of clinical trial inspections conducted by Health Canada's Inspectorate Program (Inspectorate) between April 1, 2004 and March 31, 2011. This is the third summary report of inspections of clinical trials issued since the inspection program was launched in 2002.

Last Updated: Jun. 7, 2022
Date Published: Nov. 6, 2020
Organization: Health Canada
Formats: HTML
Keywords:  summary report, inspections of clinical-ctrials, clinical-trial inspections, inspectorate program, inspectorate, third summary report
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

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

Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials

Last Updated: Jun. 7, 2022
Date Published: Jun. 1, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Clinical trials, drug importation, record-keeping for clinical-trials, frequently asked questions
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

The purpose of this guide is to help classify the level of severity of deviations noted as observations during inspections of clinical trials with drugs for human use and ensure uniformity in the assignment of ratings of observations among Inspectors of the Health Products and Food Branch (HPFB) Inspectorate.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Classification of observations, inspections, clinical trials, GUIDE-0043.
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