According
to both U.S. regulations and the ICH GCP E6 Guideline, Clinical Investigators
are required to conduct a clinical trial in compliance with the investigational
plan/protocol. Protocol deviations should not be implemented without sponsor
agreement and the prior approval/favorable opinion from the IRB/IEC, except
when necessary to eliminate an immediate safety issue for research subjects.
However, unapproved protocol deviations occur in every study and at every site.
There is a growing recognition within the industry as to the importance of
appropriately managing protocol deviations. This web seminar provides tips and
strategies to help participants anticipate, manage, and minimize the impact of
protocol deviations. Investigators and Clinical Research Associates (CRAs) will
learn how to appropriately document and report protocol deviations, with a
focus on preventing recurrence. Internal study team members will learn how to
implement a structured approach to managing significant deviations that impact
subject safety and/or data integrity.
- Describe the components of protocol deviation
documentation and reporting
- Identify stakeholder roles in the
management of protocol deviations
- Describe a process to proactively
identify, track, and evaluate deviations for greater effectiveness in
study management
- Sponsor/CRO Project Managers
- Sponsor/CRO Study Managers
- Sponsor/CRO Clinical Research
Associates
- Sponsor/CRO Clinical Research
Associate Managers
- Clinical Investigators
- Clinical Research Coordinators
- Quality Assurance Professionals
The course will be led by one of the following
instructors:
Nikki
Christison, B.S., C.C.R.A.
Marla Hoelle, R.N., B.S.N.,
C.C.R.A., P.M.P.
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 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#: 0778-0000-18-047-L01-P.
Released: 10/18.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.