On July 31, 2019 the Association of Clinical Research Professionals (ACRP) will be hosting a webinar titled, “Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance”. Michael Marotta and Bradley Lieberman from IMARC Research, Inc. will be the speakers.
This webinar 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.
The learning objectives for this webinar are to:
- Understand the different methods and possible sources for identifying AEs
- Examine the importance of establishing a process for timely assessment of events once identified
- Understand the reporting requirements and recommended procedures for AE reports to sponsors and IRBs
If you are a research coordinator or an investigator who would like to improve your site’s process for managing/assessing and reporting AEs, then this webinar is for you. Additionally, if you are from a medical device sponsor or CRO that provides training and support to clinical sites, then attend this webinar for tips and tricks about providing sites with best practices for ensuring compliance.
This webinar is approved for 1.0 ACRP contact hours. The registration deadline for the webinar is July 30, 2019, and you can click here to register.