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

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Financial Disclosure Form (FDF)• Financial disclosure is required by:‣ “Primary investigator, Sub-Investigator and/or ResearchCoordinator who is directly involved in the treatment orevaluation of research subjects”.• Disclosure information includes:‣ A financial arrangement to include a grant to fund forongoing research, compensation in form of equipment orongoing consultation honoraria exceeding $25,000.‣ Equity interest exceeding $50,000 questionnaire‣ Compensation affected by outcome of study‣ Proprietary interest in study drug10
<strong>Documents</strong> Required by Sponsor forInitial Drug/Device Shipment• Original signed/dated protocol agreement page• Copy of IRB approval letter, informed consent form, anypatient education materials and advertisements• Copy of IRB Membership List• Original signed and dated Form FDA 1572• CVs and medical license of principal, sub-investigators &study coordinator• Original signed and dated Financial disclosure Forms(FDF)• Fully Executed CTA and budget11
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 12 and 13: Study Supplies• Case Report Forms
Page 14 and 15: Site Personnel Responsibilities•
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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