CAF Ethics Pharmacivigilance

Course Description

This course identifies and describes the background and history for the protection of human subjects in clinical research. It also provides the student with a solid understanding of the ethical principles and practical challenges associated with protecting human subjects in clinical research. Students will identify and discuss ethics as a discipline, the Declaration of Helsinki, Institutional Review Boards, Informed Consent Forms, Data Management Committees/Data Monitoring Boards, Compliance, and HIPAA.

Learning Outcomes

  • Contrast the key trends in establishing the ethical environment in which we live.
  • Examine the regulatory and ethical basis for the protection of human subjects and clinical trial safety monitoring.
  • Argue the framework of the Declaration of Helsinki.
  • Evaluate and judge the responsibilities and function of Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).
  • Defend the contribution of informed consent and clinical trial safety monitoring to the protection of human subjects in clinical trials and in clinical research.


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 200,000 alumni worldwide.

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Study when and where it’s convenient for you with evening, weekend, and 100% online classes.

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Apply or transfer any time. Classes start monthly, and applications are accepted year round.

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Attend class and learn onsite at one of over 20 locations in California.

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