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.
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 165,000 alumni worldwide.
Focus on one subject at a time — one month at a time — and finish your degree faster.
100+ Degree Programs
Choose from associate, bachelor’s, and master’s degrees, plus credentials and certificates.
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Study when and where it’s convenient for you with evening, weekend, and 100% online classes.
Apply or transfer any time. Classes start monthly, and applications are accepted year round.
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Attend class onsite at one of over 20 campus locations across California or in Nevada.
As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.