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

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<strong>Essential</strong> IRB <strong>Documents</strong>Send to IRB:• Protocol / amendments• Investigator Brochure• Sponsor ApprovedConsent forms• Advertisements &BrochuresAfter Approval Obtainfrom IRB:•IRB Approval letter•IRB Approved ICF•IRB membership listIRB forms and guidance can be found at thefollowing website:http://research.ucdavis.edu/home.cfm?id=OVC,18
Contract & Budget• Contract also known as CTA for a clinical trialagreement.• Budget• 700U state required financial form - only use if privatesponsor• Form 800 (federal form required for all humansubjects studies private sponsor or otherwise)• Exhibit B (university budget template)Most of these forms can be found at theSponsored Programs websitehttp://research.ucdavis.edu/home.cfm?id=OVC,39
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 10 and 11: Financial Disclosure Form (FDF)•
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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