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Clinical Study Initiation Visit
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Item Number: NWRR3008
A 19-page procedure, including a seven-page attachment (Study Initiation Visit Report), that describes the steps to follow during a clinical study initiation visit at the investigational site prior to the enrollment of the first trial subject. Includes scheduling, preparing for, and conducting the study initiation visit; and study initiation visit observations and report. 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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