The concepts and processes of risk management are well known and often used in clinical research project management. Yet, few clinical research monitors realize the value of applying these activities to site management. This web seminar starts with an overview of risk assessment and management. The learner is then guided through the application of these techniques through all phases of study conduct: Site selection and initiation, routine monitoring, and site close-out. The course focuses on identification of site strengths and weaknesses and implementing strategies to address weaknesses before they lead to deviations or noncompliance.
- Perform a risk assessment for investigational sites focusing on the issues that matter most
- Identify key questions to evaluate potential risks during the site selection and initiation phase
- Recognize areas of greatest risk at investigative sites during study conduct
- Discuss techniques to monitor potential risks and take action if/when they become problematic
- Identify strategies to conduct site close-out visits so sites remain “audit-ready”
- Clinical Research Associates
- Clinical Research Associate Managers
- Clinical Research Professionals with responsibility for site selection and management
- Quality Assurance Professionals
Nikki Christison, B.S.
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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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-059-L01-P. Released: 10/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.