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FDA releases first draft guidance on decentralized trial conduct for medical products

The FDA today published its long-awaited new draft guidance document on the conduct of decentralized clinical trials (DCTs), outlining regulatory expectations and potential operational hurdles. The draft guidance is intended to operate in concert with other recent draft guidance on digital health technologies (DHTs) and electronic systems in clinical research, creating a foundation for more digitized research methods.

Decentralized trial policy in the U.S.

Quick background: What is a decentralized trial?

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