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CLINICAL RESEARCH TRAINING

INFORMED CONSENT: DRILLING IT DOWN

COURSE DESCRIPTION:

This course provides a detailed overview of the regulations and best practices surrounding informed consent. We go beyond the basics of ICH GCP and the regulatory requirements to provide practical tools and methodologies to enhance the informed consent process.

LEARNING OBJECTIVES:

  • Discuss the guidance and regulations surrounding informed consent and human subject protection
  • Discuss how to enhance the informed consent process
  • Navigate through the requirements governing clinical research using critical thinking skills
  • Describe best practices for creating and maintaining high-quality documentation

COURSE OUTLINE

AGENDA: Flexible 8:30am – 12:30pm,  or 12:30pm - 4:30pm, or in 2 web sessions

  • Good Clinical Practice and U.S. FDA Regulations Refresher
  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Situations
  • Human Subject Protection 
    • Drilling Down 21 CFR Part 50: Conducting and Documenting Proper Informed Consent
    • Protecting Subject Protected Health Information (PHI): HIPAA and HITECH
  • Conducting and Documenting Informed Consent: Best Practices

ADDITIONAL WEB-BASED COURSE ADD-ONS

  • History of Clinical Research
  • Maintaining the Sponsor TMF
  • Critical Thinkings in Critical Research
  • FDA Inspectional Findings

Training Solutions For These Roles

  • Principal Investigators and Sub-Investigators 
  • Research Nurses, Study Coordinators, and Clinical Research Staff conducting and documenting patient consent 


TYPE

In Person Training – At IMARC or Your Location
Remote, live via web conferencing (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
  • Certificate of Completion
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