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KUMC Research Foundation. The most effective method to Make a Clinical Trial Spending plan Clinical Examination Organization . http://www2.kumc.edu/researchinstitute/October 23, 2008 Exhibited by Kelly Daniels, CCRP. The most effective method to make a clinical trial spending plan.
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Slide 1

KUMC Research Institute How to Create a Clinical Trial Budget Clinical Research Administration http://www2.kumc.edu/researchinstitute/October 23, 2008 Presented by Kelly Daniels, CCRP

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How to make a clinical trial spending Difficulty as well as many-sided quality of the review Study arrangement prerequisites Patient numbers Length of study Inclusion/prohibition criteria for subject enlistment Staffing

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How to make a clinical trial spending Investigator Initiated Protocol: Data administration costs Study-related faculty costs Equipment/supply costs Diagnostic expenses and administrations Publication costs (readiness of composition, travel, and so on.)

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How to make a clinical trial spending Start up Costs: Protocol audit by Investigator/contemplate facilitator Determine potential number of qualified subjects Site determination visit Site start visit Off-site gatherings (Investigator\'s meeting)

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How to make a clinical trial spending Start up Costs: Detailed spending advancement Regulatory Document planning IRB accommodation, duplicates and revisions Advertising and patient enlistment Pharmacy Protocol survey/set-up expenses

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How to make a clinical trial spending plan Per subject costs: Initial enlistment costs Subject screening (medicinal history, physical exam, educated assent, lab work, x-beams, and so forth) Screen disappointments (what number of will study permit?)

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How to make a clinical trial spending plan Physical exams and therapeutic evaluations Office visits Lab work, radiology, cardiology and other restorative methods (proficient expenses) Pharmacy apportioning and medication organization Room charges and doctor\'s facility bed Determine standard of care things (as required)

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How to make a clinical trial spending Medical supplies Film duplication Study tranquilize storerooms (bolted cupboard/fridge) Telephone contact Patient guideline

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How to make a clinical trial spending plan Administrative costs: Data accumulation/administration/examination Site visit readiness/Study observing/Study questions Office supplies Shipping/get ice Dry site stockpiling Telephone charges

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How to make a clinical trial spending plan Other costs: Investigator charge Study Coordinator expense Subject stipend General Clinical Research Center administrations

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How to make a clinical trial spending Budget Preparation: Line thing point by point per visit spending plan ..\BUDGETS\3 BUDGET HELP FOLDER\CPT bud-design by visit layout whours (ver.8.1).xls Budget by recurrence ..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-organize freq template.xls PI started spending plan ..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-design PI Initiated.xls

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How to make a clinical trial spending Budget Negotiation: Do not consequently acknowledge a support spending plan. Try not to finish a financial plan until you are sure all review costs have been distinguished. Try not to consent to turning point installments. Try not to be reluctant to request more cash!

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How CRA can help arrange the spending Budget Negotiation: Review assent frame/timetable of occasions/convention Compare to support\'s spending layout Review the agreement dialect identified with the financial plan and installment.

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How CRA can help arrange the spending Budget Negotiation: Negotiate settled expenses (i.e. IRB expenses, drug store charges, regulatory expenses, and so forth.) independently from per patients costs. Ask for introductory "in advance" installment to take care of starting costs (convention audit, spending creation, pre-contemplate visits, and so on). Add monies inside the monetary allowance to cover time/exertion of PI and study organizer to cover work amid planning/ponder lead/conclusion of the review.

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Budget Contacts Kelly Daniels Research and Program Officer ext 1484 Program Administrators: Jason Winbolt ext 5709 Heidi Warren (off site) hwarren@kumc.edu

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