Clinical trials regulatory guides
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These five documents provide information about the processes of starting a clinical trial program for a drug. They provide details on the application process and requirements for clinical trials in Canada, the US and Europe.
Clinical Trial Application Canada (PDF)
Clinical Trial Application US (PDF)
Clinical Trial Authorization EU (PDF)
Toxicology Requirements for Clinical Trials (PDF)
This material is not intended to be the definitive source about how to prepare a clinical trial application, but offers an overview for the non-regulatory affairs professional of what needs to be accomplished before advancing a new product to human studies.
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