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Found 10 records similar to Filing of clinical trials Frequently Asked Questions
Health Canada answers to frequently asked questions about drug importation and record keeping for clinical trials
Clinical trials: Frequently Asked Questions.
Clinical trials: Frequently Asked Questions on outline of process.
Answers from Health Canada to frequently asked questions regarding the Canadian Nutrient File Recipe Proportions
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.
Answers from Health Canada to frequently asked questions regarding natural health products; some content intended for specific audiences
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.
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.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
An export from Canada's Open Government Partnership (OGP) Global Summit 2019 website. This document lists frequently asked questions that provided partipants relevant information about the logisitics of the event.