Clinical Research Training | Informed Consent

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 Shake^TM 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