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Participant safety monitoring in Decentralized Clinical Trials

BayBiotech.NET
Decentralized clinical trials should account for adequate processes for reporting medication errors and safety events...A well-organized plan must include training of participating HCPs on following study protocol processes for the reporting of adverse events. Not only should HCPs be made aware of the contact details of the study personnel, but participants should also be informed so they can reach out for medical assistance.
A lot of these responsibilities to prepare the logistical details fall on the study sponsor; however, study Principal Investigators also remain responsible for working with local HCPs to monitor the clinical safety of the participants...

Useful link: https://www.fda.gov/media/189263/download?attachment

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