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.
- Describe the regulatory purpose of monitoring
- Define the basic types of monitoring
visits and documentation requirements
- Explore the roles and responsibilities
of the Clinical Research Associate (Monitor) for the various types of
- Discuss the meaning of protocol and
regulatory (GCP) compliance
- Recognize the rationale behind
adequate documentation of monitoring including identification of issues,
corrective and preventive action and evaluation of effectiveness for
issues (both site and sponsor)
- Clinical Research Associates
- Project Managers
- Personnel responsible for monitoring
or managing medical device trials
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
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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.
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 1.5 hours (0.15 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#: 0778-0000-17-041-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1