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Found 10 records similar to Overview of the Clinical Trial Application Process

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 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

All Clinical Trial Applications (CTAs) and Clinical Trial Application Amendments (CTA-As) are subject to a 30-day default review period from the date of receipt of a complete application in Health Canada.

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  review of application, clinical-trial aApplications, CTAs, clinical-trial application amendments, CTA-As, default review period
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 pre-CTA consultation meeting provides an opportunity for the sponsor to present relevant data, discuss concerns and resolve issues regarding drug development. It also gives Health Canada an opportunity to provide guidance on the acceptability of the proposed trial(s).

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  pre-clinical trial application, CTA consultation meeting, clinical-trial sponsors, clinical-trial applications
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

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

Provides answers to frequently asked questions about Health Canada filing requirements for clinical trials

Last Updated: Jun. 7, 2022
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, frequently asked questions, filing of clinical-trials, filing-requirements for 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 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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