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CLINICAL RESEARCH TRAINING

RISK-BASED MONITORING: THE ESSENTIALS

COURSE DESCRIPTION:

Recent regulatory guidance and industry initiatives are promoting a modern approach to clinical trial monitoring and how to apply risk-based thinking. The course is designed for clinical research professionals across the continuum of research organizations and experience levels. Participants will learn and understand risk-based monitoring and be able to apply the strategies to day to day operational activities.

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

Training Solutions For These Roles

  • Sponsors/CROs Clinical Operations Staff, Project Managers
  • Clinical Research Associates and Managers
  • Clinical Data Management Staff
  • Sponsor-Investigators

TYPE

In Person Training – At IMARC or Your Location
Webinar (2, 2-hour sessions)


CEUs

4.0 hours (0.4 CEUs)


KNOWLEDGE LEVELS:

Beginner
Intermediate


WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References (Whitepapers and Infographics)
  • Certificate of Completion
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