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Canada Seeks To Make Decentralized Trials More Practical For Sponsors

MHRA Points To Existing Flexibilities In UK Regulations To Enable Remote Studies

 
• By Vibha Sharma

By formally adopting a modernized definition of a clinical trial site, Health Canada is hoping to provide greater flexibility to sponsors who want to incorporate decentralized elements in their trials.

Woman discussing with doctor through tablet PC at home
A Patient's Home, Where Trial-Related Activities Are Conducted, Will Qualify As A Clinical Trial Site • Source: Alamy

As part of ongoing efforts to modernize its clinical trials framework, Health Canada is planning to introduce measures to support the conduct of decentralized studies. Among these are plans to adopt a formal definition of what constitutes a clinical trial site.

The term is currently not defined in Canadian regulations and has resulted in a “lot of questions regarding this topic...

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