Open Government Portal

Found 10 records similar to Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

Federal

During the pandemic, there may be more deviations from the established protocol. Despite this, it’s important to continue to protect patient safety and ensure data integrity. This notice addresses the concerns of clinical trial sponsors and Canadians.

Last Updated: May 28, 2021
Date Published: May 6, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, management of clinical trials, notice to clinical trial sponsors, established protocol, patient safety, data integrity
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

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
Federal

Clinical trials, or investigational testing, are tests done to look at the safety and effectiveness of a medical device. These trials are authorized by Health Canada and are conducted on a device that may be used for another purpose or is not yet available in Canada.

Last Updated: Jun. 7, 2022
Date Published: Mar. 2, 2022
Organization: Health Canada
Formats: HTML
Keywords:  clinical-trials, medical-devices for COVID-19, safety-and-effectiveness of medical-devices
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19, list of authorized clinical trials
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
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

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, vaccine, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials for drug and vaccine related to COVID-19
Federal

The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory oversight provided by the Interim order respecting clinical trials for medical devices and drugs relating to COVID-19 until at least the fall of 2021, and bring forward regulatory amendments that would allow the flexibilities under the Interim Order to continue after the fall of 2021.

Last Updated: Jul. 27, 2021
Date Published: Dec. 10, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, predictability, regulatory oversight, COVID-19 clinical trials, clinical trials, medical devices and drugs, notice to stakeholders, Interim Order
Federal

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19
Date modified: