US FDA Announces Webinar to Discuss Decentralized Trial Draft Guidance

US FDA recently released the draft guidance on decentralized clinical trials and has also scheduled a webinar to discuss this draft guidance. The draft guidance is on – Decentralized Clinical Trials for Drugs, Biological Products, and Devices Draft Guidance for Industry, Investigators, and Other Stakeholders (fda.gov)

 

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.