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Does the CTR provide an opportunity to reset perceptions around the need for finalized eCOA screenshots and localized app content?
In general, the United States (US) has evolved to a world where finalized eCOA screenshots are not required, but research is a global activity, so we have to consider other territories. There is still a perception that outside of the US, submissions need to follow the de facto assumptions around the need for finalized eCOA screenshots and localized app content, however recent changes in the global regulatory landscape may provide an opportunity for change and harmonization of processes between the US and European Union (EU).
In this report we challenge the ‘requirement’ for finalized electronic Clinical Outcome Assessment (eCOA) screenshots and localized application (app) content as part of the Institutional Review Board (IRB) / Independent Ethics Committees (Ethics) approval process.
