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Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features
Session Chair(s)
Cara Alfaro, PharmD
Senior Pharmacologist, OSI, OC, CDER
FDA, United States
The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.
Learning Objective : Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.
Speaker(s)
FDA Update
Cara Alfaro, PharmD
FDA, United States
Senior Pharmacologist, OSI, OC, CDER
Industry Update
Jonathan Andrus, MS
CRIO, United States
Co-CEO
Panelist
Kassa Ayalew, MD, MPH
FDA, United States
Director, DCCE, OSI, Office of Compliance, CDER
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