The
regulations require that sponsors ensure the selection of qualified monitors
and the proper monitoring of clinical investigations. However, sponsors are
frequently cited by the FDA for failure to meet those requirements. These
regulatory communications note that although monitors might have identified
issues, they did not appreciate the significance of those findings. As a
result, opportunities to promptly secure compliance might be missed.
Clinical research is
structured to incorporate monitoring processes more frequently than auditing.
Yet as monitoring integrates a risk-based approach, monitors can utilize many
auditing techniques to assist them in more effectively performing their tasks
and meeting their obligations. This web seminar will explore the processes for
critically reviewing findings to discern the implications and impact on subject
safety and data integrity.
- Utilize auditing techniques when performing
monitoring tasks
- Define “proper monitoring” and who
is responsible for its conduct
- Discuss monitoring findings within
the context of regulatory risk
- Review standard monitoring report
templates and discuss ways to adapt them to develop a compliance
assessment
- Describe processes for discerning
patterns in information reviewed
- Explore methods for developing
monitoring tools that facilitate a systems review and communication
- Clinical Research Associates
- Clinical Research Associate Managers
- Project Managers
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$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.
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#: 0778-0000-20-051-L01-P.
Released: 4/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.