ACRP 2018 Meeting & Expo

123 - Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective

Apr 28, 2018 11:30am ‐ Apr 28, 2018 12:30pm


Credits: None available.

Members: $25.00
Standard: $75.00

Description

Learn the ins and outs of adverse event (AE) reporting for medical device trials. Speakers will cover the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on the study protocol, and device AE reporting requirements from a monitoring and auditing mindset. Participate in an active discussion of AE requirements in 21CRF812 and 21CRF312, FDA’s current thinking on AE reporting in device trials and how this might impact which AEs are required to be reported, and how sites might need to delineate AE reporting between the protocol and their Institutional Review Board requirements. Hear several AE reporting case studies from monitoring and auditing perspectives.

Learning Objectives:

  • Understand the differences between adverse event (AE) reporting requirements under 21 CFR 812 vs. 312.
  • Determine appropriate AE reporting requirements for your medical device trial based on the study protocol.
  • Critically examine AE reporting requirements and processes for medical device trials, with a focus on monitoring and auditing perspectives.

Speaker(s):

  • Stephani Hulec, MS, CCRA, Associate Director of Clinical Monitoring Services, IMARC Research, Inc.
  • Michael Marotta, MS, Manager, Clinical Monitoring Services, IMARC Research Inc.

Credits Available


Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective

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