Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance
Please click here to purchase your contact hour
Michael Marotta and Bradley Lieberman, IMARC Research, Inc.
- 11:30 am –12:00 –Networking/Lunch Provided
- 12:00 – 1:00 pm – Educational Presentation including Q&A
Program Description: 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 Seminar, attendees should be able to:
- Understand the different methods and possible sources for identifying adverse events.
- Understand the reporting requirements and recommended procedures for AE reports to sponsors and IRBs.
Target Audience: Clinical Research Coordinator, Clinical Research Nurse, Data Manager, Manager of Regulatory Affairs, Investigator, Medical Research Scientist, Pharmacist, Project Manager, Quality Control Specialist, Research Manager, Research Technician or Assistant, Statistician, Trainer
Registration Cost: FREE to all Chapter, ACRP, and non-members including lunch
Contact hours: 1.0 ACRP contact hours are available for this presentation.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not specified
Level: Not specified
Shelley Welch at 304-293-7348
Connie Cerullo at 240-415-6013