IRB Submissions & EU Clinical Trials Submissions

223-06-10 From the early days of eCOA, as an industry we have set expectations with Ethics committees around what is included in their submission packets for review, namely finalized, localized screenshots. This leads to additional burden for all as we strive to meet submissions dates and hit FPI dates. The advent of the new EU Clinical Trial Regulation provides us with an opportunity to reset that expectation and effectively plan for global research. Paul Taylor and Chris Watson from THREAD Research joined hosts Craig Lipset, Amir Kalali, and Jane Myles for the conversation.

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