CLINICAL RESEARCH TRAINING

COURSE DESCRIPTION:

LEARNING OBJECTIVES:

• Compare and contrast traditional monitoring with risk-based monitoring
• Identify clinical study risks and how risks might be mitigated
• Develop a monitoring plan which focuses on mitigating risks at both the program and study levels
• Describe approaches and techniques for central/remote monitoring
• Apply risk management in real-world case scenarios

COURSE OUTLINE

AGENDA: 4 hours in person or in 2 web sessions

• Risk-Based Monitoring Overview: FDA Guidance and ICH GCP E6
• Conducting Risk Assessment: Identifying, Evaluating, and Mitigating Risks
• Developing Monitoring Plans: Planning and Implementation
• Risk-Based Monitoring Throughout a Study: Best Practices & Methods
• Building Quality into Clinical Research Studies

ADDITIONAL WEB-BASED COURSE ADD-ONS

• GCP & U.S. FDA Regulations Refresher
• Critical Thinking in Clinical Research
• FAIR ShakeTM
• Site Management
• Monitoring with an Auditing Perspective
• FDA Inspectional Findings