When conducting clinical trials in Canada, a Sponsor must generally possess, for each clinical trial site, a Research Ethics Board Attestation (REBA), which provides administrative information regarding the research ethics board (REB) as well as a certification that its composition, operations and decisions are in compliance with Canadian regulations. A REBA must also be completed […]
Category Archives: Guidelines & Regulations
11
Apr
Apr
If you are a Sponsor/CRO conducting clinical research in both Canada and the U.S., there are important differences between the Canadian Clinical Trial Application (CTA) and the U.S. Investigational New Drug (IND) submission process. IND Submission Process in the U.S. In the U.S., once the IND has been submitted for review, the FDA has 30 […]
07
Apr
Apr
Are you involved in multi-national clinical research in North America? Are you wondering whether – and where – you have to register a clinical trial? And why? Why should we register this clinical trial? Let’s address the ‘why’ question first. Registration is internationally recognized as a scientific, ethical and moral responsibility that “will improve research […]
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