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

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Site Personnel Responsibilities• Delegated by principal investigator• Recorded in Delegation of Responsibilities Log• Include appropriate education, training & experience14

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DEAN'S AWARD FOR EXCELLENCE IN MENTORING

Site Personnel Responsibilities• Delegated by principal investigator• Recorded in Delegation of Responsibilities Log• Include appropriate education, training & experience14

Prepare <strong>Study</strong> Files• Use sponsor-designated sections• File documents immediately• Ensure documents filed consistently15

Page 1 and 2: Study Start-Up &Essential Documents
Page 4 and 5: Confidentiality Agreement• A Conf
Page 6 and 7: Investigator Meeting• Site traini
Page 8 and 9: Essential IRB DocumentsSend to IRB:
Page 10 and 11: Financial Disclosure Form (FDF)•
Page 12 and 13: Study Supplies• Case Report Forms
Page 16 and 17: Source Documentation• A source do
Page 18 and 19: Initiation VisitTakes place after s
Page 20 and 21: SummaryDuring the study start-up ph

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

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