MRA 602 Human Subjects in Clinical Tri
Lead Faculty: Mr. Irvin Kluth
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.
- 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.