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CLINICAL RESEARCH TRAINING

Critical Thinking for Clinical Research Professionals: Master Class

COURSE DESCRIPTION:

This dynamic workshop-style course provides clinical research professionals with a foundation for understanding critical thinking skills, tools to improve their thinking practices, and practical applications for the clinical research industry. Advanced concepts will be presented and will be tailored to the audience to explore how sponsor, CRO, and/or site staff can effectively assess problems, gather information, and use disciplined thinking to improve the quality of their research studies.

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 ShakeTM 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 ShakeTM 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

Training Solutions For These Roles

  • Project Managers, CRAs, Auditors
  • Team Managers, Data Managers
  • Research Coordinators, Research Managers
  • Investigators

TYPE

In Person Training – At IMARC or Your Location


CEUs

8.0 hours (0.8 CEUs)


KNOWLEDGE LEVELS:

Intermediate
Experienced


WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References
  • Certificate of Completion
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