Root Cause Analysis: Applying the Concept for Better Study Compliance Management

Course Description

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).

Learning Objectives

• 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

Who Should Attend

• Clinical Research Coordinators
• Clinical Research Associates
• Site Managers
• Clinical Research Associate Managers
• Project Managers

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Click here for complete trainer biographies

Registration Fees

$835

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 2.5 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#: 0778-0000-23-068-L99-P. Released: 8/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.