Free Resource: The COVID-19 Protocol Checklist

The FDA recently issued the following guidance: “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic; Guidance for Industry, Investigators, and Institutional Review Boards”; March 2020, Updated April 16, 2020. The Bracken Group created two checklists: one to determine whether the sponsor should suspend or continue the ongoing study or initiate a new study, the other how best to update the protocol.

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