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CLINICAL RESEARCH TRAINING

CLINICAL RESEARCH COORDINATOR: THE ESSENTIALS

COURSE DESCRIPTION:

This one-day course provides an excellent introduction to clinical research and CRC job responsibilities. New or aspiring clinical research coordinators (CRCs) will be introduced to regulations, best practices, and their roles and responsibilities within a clinical trial.

LEARNING OBJECTIVES:

  • Review FDA regulations and the ICH GCP E6 Guideline for Good Clinical Practice (GCPs)

  • Describe the roles and responsibilities of the Clinical Research Coordinator, Principal Investigator, and Sponsor (PM and CRA)

  • Review the different types of Monitoring Visits, including preparation, conduct, documentation and follow-up

  • Describe definitions related to safety management, identification of adverse events, and reporting requirements

  • 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 research coordinator

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 Overview

    • Project Manager, Monitor, Primary Investigator, Clinical Research Coordinator, Data Manager, and Statistician

  • Monitoring Visits: Hosting and Follow-up
  • High Quality Documentation and Study Records
    • Source Documentation

    • Adverse Event Classification and Reporting

    • Investigational Product Accountability

  • Day in The Life of an Effective Clinical Research Coordinator: Best Practices

TYPE

  •  In Person Training
 
CONTINUING EDUCATION CONTACT HOURS (CEUs)
7.0 hours (0.7 CEUs)

KNOWLEDGE LEVELS:

  • Beginner
  • Intermediate

WHAT’S INCLUDED

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

Training Solutions For These Roles

  • Clinical Research Coordinators with limited experience in managing industry-sponsored studies

  • Experienced Coordinators seeking to review the fundamentals of clinical research regulations

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