Adverse Event Monitoring for CRAs
During monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post-marketing labeling. This includes causality, expectedness/unanticipated, and other important concepts. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.
- Define safety concepts and reporting requirements
- Recognize the importance of verifying the subject baseline history
- Determine when to start and stop monitoring AEs
- Apply a detailed presentation of the source document verification process of AEs
- Manage challenges in monitoring AEs
- Determine appropriate credentialing for site AE evaluation of event relationship
- Describe the impact of monitoring on future product labeling
- Discuss reporting trends
Who Should Attend
- Device and Drug Study Clinical Research Associates
- Contract Clinical Research Associates
- Clinical Research Associate Managers
- Project Managers
Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: email@example.com
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-20-024-L01-P. Released: 1/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.