Decentralized Clinical Trials (DCT) Draft Guidance

FDA provides an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices. FDA experts Discuss topics such as 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, and roles and responsibilities of the sponsor and investigators in a DCT.
Timestamps
00:56 - Intro - Decentralized Clinical Trials for Drugs, Biological Products, and Devices
04:25 - Overview of the DCT Draft Guidance
30:35 - Q&A Discussion Panel
Speakers:
Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies
Office of Medical Policy (OMP) | CDER | FDA
Ryan Robinson, MD
Medical Officer
Clinical Methodologies
OMP | CDER | FDA
Panelists:
Same as above
Learn more at: www.fda.gov/dr...
-----------------------
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - www.fda.gov/cd...
SBIA Listserv - public.govdeli...
SBIA 2022 Playlist - • 2022 CDER Small Busine...
SBIA LinkedIn -  / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter -  / fda_drug_info
Email - [e-mail]
Phone - [phone] I [phone]