Presentation on theme: "KUMC Research Institute"— Presentation transcript:
1KUMC Research Institute How to Create a ClinicalTrial BudgetClinical Research AdministrationOctober 15, 2007
2How to create a clinical trial budget Difficulty and/or complexity of the studyStudy preparation requirementsPatient numbersLength of studyInclusion/exclusion criteria for subject recruitmentStaffing
3How 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)
4How 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
5How 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?)
6How 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)
7How to create a clinical trial budget Medical suppliesFilm duplicationStudy drug storage facilities (locked cabinet/refrigerator)Telephone contactPatient instruction
8How to create a clinical trial budget Administrative costs:Data collection/management/analysisSite visit preparation/Study monitoring/Study queriesOffice suppliesShipping/dry iceOff site storageTelephone charges
9How to create a clinical trial budget Other costs:Investigator feeStudy Coordinator feeSubject stipendGeneral Clinical Research Center services
10How 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
11How 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!
12How 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.
13Budget 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