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Study Start-Up & Essential Documents - UC Davis Health System

Study Start-Up & Essential Documents - UC Davis Health System

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SummaryDuring the study start-up phase, the Investigative site should:• Review the protocol• Attend the Pre-study visit and investigator’s meeting Obtain<strong>Essential</strong> <strong>Documents</strong>• Organize study files and supplies• Determine site personnel responsibilities• Plan for subject recruitment• Participate in the site initiation visit20

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