Root Cause Analysis February 2010

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. Millions of dollars are wasted yearly on ineffective interventions. This course 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 IRB.

Learning Objectives____________________________

Define root cause analysis concepts and definitions
Implement Gilbert’s Root Cause Analysis Diagnostic Process
Apply root cause in clinical trial study site management
Assign the right intervention for successful solutions
Proactively use root cause analysis to manage stakeholder compliance: research site management, CRA management, and more

Who Should Attend_____________________________

CRCs
CRAs
Site Managers
CRA Managers
Project Managers

Instructor _____________________________________

Sandra “SAM” Sather, MS, BSN, CCRA, CCRC

Click here for complete trainer biographies

Course Length and Time________________________

2.5 hours; 12:30 - 3:00 p.m. Eastern

Course Dates _________________________________

February 8, 2010

Fee_________________________________________

$595

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, call 1-800-856-2556 for pricing.

Accreditation________________________________

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 mail ACPE statements within three weeks of program completion. ACPE#: 778-000-07-021-L04-P. Released: 9/07.