Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials
FDA Law Blog
MAY 4, 2023
Study visits can be conducted using telehealth visits if in-person interaction is not necessary. FDA has also launched a series of five public workshops on issues related to DHTs in regulatory decision-making. Trial personnel can also be sent to participant’s homes. Finally, the draft guidance addresses the use of software in a DCT.
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