Event Date: November 13, 2018, 12:00-1:00pm ET
Registration Deadline: November 12, 2018
Member: $15 | Nonmember: $75
This course is approved for 1.0 ACRP contact hours. Accreditation Details
Member: $0 | Nonmember: N/A
This session will cover adverse event (AE) reporting for medical device clinical trials, including the following topics: the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on a study protocol, and a discussion on device AE reporting requirements from a monitoring and auditing mindset. There will be an overview of AE requirements in 21CRF812 and 21CFR312; a discussion about the FDA’s current thinking on AE reporting in device trials and how this may impact what AEs are required to be reported in an investigational device study protocol; a discussion on how sites may need to delineate AE reporting between the protocol and their IRB requirements; and an overview of several AE reporting case studies from monitoring and auditing perspectives.
Upon completion of this Webinar, attendees should be able to:
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