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Monitoring of Clinical Sites
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Item Number: NWRR3010
A 22-page procedure, including two attachments (Action Items for Monitors During Site Visits, and Monitoring Report), that describes monitoring of clinical sites by the sponsor, including: selection and qualification of monitors; monitoring procedures/plans; monitor’s responsibilities; site monitoring visit; documentation review; general monitoring actions; protocol violation/deviation; monitoring report; and communications between visits. 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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