Course Description
This web seminar will provide the core concepts involved in monitoring medical device studies, including activities conducted at the investigator site, communication between monitor visits, and monitoring with centralized systems. We will explore the monitoring concepts as provided by the FDA in the Risk-Based Monitoring Guidance, as well as the ICH as interpreted for medical device trials. The basics of clinical monitoring and appropriate documentation to support adequate oversight of the study will be covered. Sponsor responsibilities and the role of the Clinical Research Associate/ Monitor will be explored.
Learning Objectives
Who Should Attend
Instructors
The course will be led by one of the following instructors:
Heather Marshall, M.S.N., B.S.N., R.N.
Shana Zink, B.S., C.C.R.A.
Click here for complete trainer biographies
Registration Fees
$735
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: customer.service@barnettinternational.com
Accreditation Information
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#: 0778-0000-23-017-L99-P. Released: 1/23.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.