Webinar Replays


WR20 - Webinar Replay: Best of ACRP 2018: Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective


Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm

Expiration Date: Nov 14, 2019


Credits: None available.

  0       0

Description

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.

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):

Credits Available


Webinar Replay: Best of ACRP 2018: Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective Exam

You must be logged in and own this session in order to post comments.

Print Certificate
Review Answers
Print Transcript
Completed on: token-completed_on
Review Answers
Please select the appropriate credit type:
/
test_id: 
credits: 
completed on: 
rendered in: 
* - Indicates answer is required.
token-content
token-speaker-name image
token-speaker-name
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
token-index
token-content
/
/
token-index
token-content