US FDA Announces Webinar to Discuss Decentralized Trial Draft Guidance

India Proposed Amendment To New Drugs And Clinical Trials Rules
US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled a webinar to discuss this draft guidance. The draft guidance is on – Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (
Webinar details:
  • Date: June 20, 2023
  • Time: 3:00 PM – 4:00 PM ET
Topics to be covered include the design of a DCT, conduct of remote clinical trial visits and clinical trial-related activities in a DCT, use of digital health technologies to remotely acquire data in a DCT, roles and responsibilities of the sponsor and investigators in a DCT e.t.c.
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