Article | April 13, 2020

A Summary Of FDA Guidance On COVID-19: Patient Safety And Adapting Processes

Source: TransPerfect

By William Mellinger, Communications and Product Strategist, Trial Interactive & Gillian Gittens, Director, E-Clinical Strategy & Solutions, Trial Interactive

fda approval

How do we proceed in times like these? That is a question bouncing around the minds of people worldwide. For many, the answer is simply “stay at home and wait.” However, in the medical community, the show must go on. That community includes many clinical trials. Participants are actively being treated, and so it is important study teams find a way to continue. There are no elegant solutions to a pandemic, but much of what enables us to respond, both at home and in business, is our digital infrastructure. Recently, the FDA released some guidance to help study teams make decisions, as well as handle the documentation regarding related changes to their operations and protocol.

Following is a quick, itemized rundown of their guidance for ongoing trials (focused on Discussion Section A of the guidance), each followed by some commentary to provide additional food for thought

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