CLINICAL RESEARCH TRAINING

COURSE DESCRIPTION:

LEARNING OBJECTIVES:

• Define critical thinking, list six core skills, and identify active processes for applying them
• Understand the importance of using critical thinking within the clinical research framework
• Identify key US regulations required for running clinical trials
• Recall the elements of the FAIR Shake^TM Method and discuss the importance of basing clinical research decisions in a regulatory foundation
• Exercise critical thinking skills in real world case scenarios
• Recall strategies for building quality into your clinical trial, using risk assessment and mitigation techniques during the planning phase, and the importance of ongoing analysis during a study
• Demonstrate an ability to evaluate risks and implement mitigation techniques in sample scenarios
• Recall the process of FDA inspections and strategies for successful preparation throughout a study and at the time of inspection

COURSE OUTLINE

AGENDA: 8:00am - 5:00pm

• Critical Thinking for Clinical Researchers Overview and the FAIR Shake^TM Method
• Planning Phase: Quality Approaches, Risk Assessment and Mitigation Planning
  • Setting Your Study Up for Success Before Day 1
  • Group Exercise: What’s on Your Plate? Assess risks and mitigation strategies for YOUR studies
• A Well-Laid Plan – Is it Enough for Continued Success?
  • Implementation Phase of a Study
  • Case Study: Worst Case Scenario – When Research Goes Off the Rails, and How to Get Back on Track
  • Group Exercise: Dealing with Curveballs for YOUR studies
• The End Game – Are We Ready?
  • Study Close-out Phase
  • Regulatory Inspection Preparation
• Wrap Up – Q&A – Review Action Plans

ADDITIONAL WEB-BASED COURSE ADD-ONS

• History of Clinical Research
• Effective Study Management
• Adverse Event Classification and Reporting
• FDA Inspectional Findings