Managing
compliance in the research industry is vital to successful clinical trials.
Regulatory authorities expect that all stakeholders identify non-compliance,
intervene, and then evaluate the effectiveness of the intervention. Without
root cause analysis, interventions cannot be effectively identified and
designed. This web seminar will present the scientific concepts of root cause
analysis and apply them specifically in the clinical trial setting. Root cause
analysis is invaluable for all stakeholders in clinical research, the sponsor,
CRO, site, and Institutional Review Board (IRB).
- Define root cause analysis concepts
- Implement Gilbert’s Root Cause
Analysis Diagnostic Process
- Apply root cause analysis in
clinical trial study site management
- Assign the right intervention for
successful solutions
- Integrate proactive root cause
analysis to manage stakeholder compliance: Research site management,
Clinical Research Associate (CRA) management, and more
- Clinical Research Coordinators
- Clinical Research Associates
- Site Managers
- Clinical Research Associate Managers
- Project Managers
The course will be led by one of the following
instructors:
Jeanne Morris, B.S., MT
(ASCP)
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$625
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 2.5 hours (0.25 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#: 0778-0000-20-082-L04-P.
Released: 12/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.