challenges faced by staff, PIs and IRBs but most importantly the participants in our clinical trials. It is not common for the FDA to release a guidance document without first requesting public feedback; however, as we all know these are not normal circumstances.

As many of you are aware, the FDA released a COVID-19 Guidance Document on 3/17/20 that not only acknowledges the challenges faced by staff, PIs and IRBs but most importantly the participants in our clinical trials. It is not common for the FDA to release a guidance document without first requesting public feedback; however, as we all know these are not normal circumstances.

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