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MRA 602 Human Subjects in Clinical Tri

Lead Faculty: Mr. Irvin Kluth

Course Description

This course is designed to give the student the fundamental knowledge in the protection of human subjects in a clinical trial. The course will emphasize federal, state and local regulations in protecting the health and welfare of human subjects in a clinical trial. Proper documentation, HIPAA regulations, IRBs, international codes of conduct, Declaration of Helsinki, Informed Consent, adverse events CFRs and all other pertinent documents and codes will be covered.

Learning Outcomes

  • Understand HIPPA regulations.
  • Understand the Code of Federal Regulations as it applies to human subjects.
  • Develop and implement informed consent documents.
  • Develop and implement documentation and protocols for adverse events, their monitoring and reporting.
  • Understand the methodology of a clinical research project and how it applies to human safety.
  • Understand the role and function of data safety committees.
  • Interact with IRB and develop risk analysis for IRB approval.