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Medical Devices, Pharmaceuticals

Ethical Review Boards

About the Course

This online course addresses the role, responsibilities, and regulatory requirements of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) in protecting the rights and welfare of human research subjects. In this eLearning course, the learner will review FDA regulations, ICH GCP guidelines, and an overview of the EU Clinical Trial Directive to gain a better understanding of the relationship among the IRB/IEC, sponsor/monitor, and investigator/subjects. Upon completing this compliance training course, IRB/IEC members, investigators, and sponsors/CROs will understand their obligations in relation to the IRB/IEC, and will be able to ensure that policies and procedures developed for compliance will protect and safeguard the research subjects.