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Informed Consent
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Item Number: NWRR3011
A 17-page procedure, including one attachment [Informed Consent Form (Example)], that describes the informed consent process, preparation of the Informed Consent Form, and approval of the Informed Consent Form for use. The procedure includes investigator responsibility, execution of the Informed Consent Form, procedure for alternative informed consent, and emergency or compassionate use. This document assigns responsibility for each step of the procedure and applies to all clinical trials for an investigational drug, biologic, or device that involves human subjects.
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