Courses

CAF Ethics Pharmacivigilance

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.

Prerequisites

Recommended: Prior completion of

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