The Association of Clinical Research Professionals

Webinar Replay: Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance

Pricing With Contact Hours

Member: $15 | Nonmember: $75

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires July 31, 2020.


Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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Webinar Replay Expires July 31, 2020.


Speakers:

  • Michael Marotta, Manager, Clinical Monitoring Services, IMARC Research, Inc.
  • Bradley Lieberman, Manager, Clinical Monitoring Services, IMARC Research, Inc.

This session will cover identifying, assessing, and reporting adverse events (AEs) for medical device studies at the site level. An overview of the possible sources for potential events will be provided along with best practices for establishing a process of assessing events and a workflow for reporting events to sponsors and IRBs. Common hurdles that sites face and possible solutions will be provided. This course will explain how to apply 21CFR812, ICH-GCP E6, ISO 14155, protocol requirements and IRB policies. Actual questions from FDA investigators during site audits will be included.

Upon completion of this Webinar, attendees should be able to:

  1. Understand the different methods and possible sources for identifying adverse events.
  2. Understand the reporting requirements and recommended procedures for AE reports to sponsors and IRBs.