Decentralized Clinical Trials (DCT) Draft Guidance
ฝัง
- เผยแพร่เมื่อ 24 ก.ค. 2023
- FDA provides an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.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04:25 - Overview of the DCT Draft Guidance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
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