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

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Source Documentation• A source document is the first recording of a studyobservation• Use single line with date & initials to correct erroneousinformation• Verify all data points on CRF in source documents• Sign & date all source documents in black ink• Record what is source document• Use source identifiers16
<strong>Study</strong> Drug Accountability• Inventory drug• Check for discrepancies• Acknowledge receipt of drug• Ensure appropriate storage conditions• Prepare drug accountability log• Understand randomization system• Clarify unblinding proceduresCompleted and managed by theInvestigational Drug Service (IDS)17
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 14 and 15: Site Personnel Responsibilities•
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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