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CLINICAL RESEARCH TRAINING

Clinical Research Associates: The Essentials

COURSE DESCRIPTION:

This one-day course provides an excellent introduction to clinical research for entry level CRAs. New and aspiring clinical research associates will be introduced to regulations, best practices, and their roles and responsibilities within a clinical trial.

LEARNING OBJECTIVES:

  • Recall FDA regulations and Good Clinical Practices

  • Identify differences between drug and device clinical studies

  • Describe the different types of Monitoring Visits and responsibilities of monitors, including preparation,

    conduct, documentation, and site management

  • Recall the elements of the FAIR ShakeTM Method, apply the method to potential compliance concerns, and understand the importance of supporting recommendations with the FAIR ShakeTM Method.

  • Identify best practices and skills to be an effective monitor

COURSE OUTLINE

AGENDA: 8:30 am - 4:30 pm

  • The History of Clinical Research

  • Introduction to Good Clinical Practice: ICH GCP Guidelines

  • Introduction to the U.S. FDA Regulations for Clinical Research

    • 21 CFR Parts 312, 812, 50, 56, 54, and 11

    • INDs vs IDEs: Comparing 21 CFR Parts 312 and 812

  • Human Subject Protection

    • Drilling Down 21 CFR Part 50: Conducting and Documenting Proper Informed Consent

    • Protecting Subject Protected Health Information (PHI): HIPAA and HITECH

  • The FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Key Roles and Responsibilities in Clinical Research: CRA Focused

  • Monitoring Visits Overview:

    • Visit Types: Site Assessment Visits, Site Initiation Visits, Periodic Site Visits, and Close Out Visits

    • Visit Preparation, Conduct, Documentation, and Follow-up

  • Day In the Life of an Effective Clinical Research Associate: Best Practices

    • Adverse Event Classification and Reporting

    • Investigational Product Accountability

    • High Quality Documentation and Maintaining the Sponsor TMF

Training Solutions For These Roles

  • Aspiring Clinical Research Associates

  • New Clinical Research Associates with limited experience


TYPE

In Person Training – At IMARC or Your Location


CEUs

7.0 hours (0.7 CEUs)


KNOWLEDGE LEVELS:

Beginner


WHAT’S INCLUDED

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