Open Government Portal
Found 10 records similar to Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
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.
As set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR), clinical trials must follow certain requirements of the protocol. Health Canada authorizes this protocol and the Research Ethics Board approves it. During the pandemic, there may be more deviations from the established protocol.
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.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
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.
Learn about the outcomes of the public consultations on the COVID-19 clinical trials Interim Order and clinical trials records retention.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
IO No. 2 supports Canada’s continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.
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.
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.