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Medical Devices, Pharmaceuticals

Protection of Human Subjects in Clinical Trials

About the Course

Protection of human subjects is the foremost and most important duty of investigators conducting clinical trials. This online course will provide you with a working knowledge of informed consent regulations, Institutional Review Board/Independent Ethics Committee responsibilities, and the obligations of the individuals responsible for protecting patient rights and welfare. Topics in this eLearning course include: Consent Form, Consent Process, Consent Exceptions, IRB/IEC, and IRB/IEC Responsibilities. After completing this regulatory compliance course, learners will be able to identify the measures that are in place to protect the rights and welfare of subjects in clinical studies. Learners will also be able to recognize informed consent requirements and regulations, the responsibilities of an IRB/IEC, and the obligations of individuals responsible for working according to GCP.