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ARTICLE | Regulation

FDA clarifies remote trial monitoring guidance during COVID-19

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April 17, 2020 9:47 PM UTC
Updated on Apr 18, 2020 at 7:01 AM UTC

FDA is answering the call from companies for more clarity on conducting clinical trials during COVID-19 with updated guidance on remote treatment and monitoring procedures.

The agency issued updates to the non-binding question-and-answer appendix of its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” on Friday to cover remote outcomes reporting, documentation requirements, therapy administration, and more. ...