Presentation on theme: "KUMC Research Institute"— Presentation transcript:
1 KUMC Research Institute How to Create a ClinicalTrial BudgetClinical Research AdministrationOctober 15, 2007
2 How to create a clinical trial budget Difficulty and/or complexity of the studyStudy preparation requirementsPatient numbersLength of studyInclusion/exclusion criteria for subject recruitmentStaffing
3 How to create a clinical trial budget Start up Costs:Protocol review by PI/study coordinatorDetermine potential number of eligible subjectsSite selection visitSite initiation visitOff-site meetings (Investigator’s meeting)
4 How to create a clinical trial budget Start up Costs:Detailed budget developmentRegulatory Document preparationIRB submission, copies and amendmentsAdvertising and patient recruitmentPharmacy Protocol review/set-up costs
5 How to create a clinical trial budget Per subject costs:Initial enrollment costsSubject screening (medical history, physical exam, informed consent, lab work, x-rays, etc)Screen failures (how many will study allow?)
6 How to create a clinical trial budget Physical exams and medical assessmentsOffice visitsLab work, radiology, cardiology and other medical procedures (professional fees)Pharmacy dispensing and drug administrationRoom charges and hospital bedDetermine standard of care items (as needed)
7 How to create a clinical trial budget Medical suppliesFilm duplicationStudy drug storage facilities (locked cabinet/refrigerator)Telephone contactPatient instruction
8 How to create a clinical trial budget Administrative costs:Data collection/management/analysisSite visit preparation/Study monitoring/Study queriesOffice suppliesShipping/dry iceOff site storageTelephone charges
9 How to create a clinical trial budget Other costs:Investigator feeStudy Coordinator feeSubject stipendGeneral Clinical Research Center services
10 How to create a clinical trial budget Budget Preparation:Line item detailed per visit budget ..\BUDGETS\3 BUDGET HELP FOLDER\CPT bud-format by visit template-whours (ver.8.1).xlsBudget by frequency..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-format freq template.xlsPI initiated budget ..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-format PI Initiated.xls
11 How to create a clinical trial budget Budget Negotiation:Do not automatically accept a sponsor budget.Do not finalize a budget until you are confident all study costs have been identified.Do not agree to milestone payments.Do not be afraid to ask for more money!
12 How CRA can help negotiate the budget Budget Negotiation:Review consent form/schedule of events/protocolCompare to sponsor’s budget templateReview the contract language related to the budget and payment.Negotiate fixed costs (i.e. IRB fees, pharmacy fees, administrative fees, etc.) separately from per patients costs.Request initial “up-front” payment to cover initial costs (protocol review, budget creation, pre-study visits, etc).Add monies within the budget to cover time/effort of PI and study coordinator to cover work during preparation/study conduct/closure of the study.
13 Budget Contacts Diana Naser, Director ext 1242 Kelly Daniels, Assistant Director ext 1484Clinical Trial Administrators:Molly Gunter ext 5969Barb Liles ext 5589Alec Johnson ext 1262Jody Kittell ext 5705Kris Keller ext 5718
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