KUMC Research Institute

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Presentation transcript:

KUMC Research Institute How to Create a Clinical Trial Budget Clinical Research Administration http://www2.kumc.edu/researchinstitute/ October 15, 2007

How to create a clinical trial budget Difficulty and/or complexity of the study Study preparation requirements Patient numbers Length of study Inclusion/exclusion criteria for subject recruitment Staffing

How to create a clinical trial budget Start up Costs: Protocol review by PI/study coordinator Determine potential number of eligible subjects Site selection visit Site initiation visit Off-site meetings (Investigator’s meeting)

How to create a clinical trial budget Start up Costs: Detailed budget development Regulatory Document preparation IRB submission, copies and amendments Advertising and patient recruitment Pharmacy Protocol review/set-up costs

How to create a clinical trial budget Per subject costs: Initial enrollment costs Subject screening (medical history, physical exam, informed consent, lab work, x-rays, etc) Screen failures (how many will study allow?)

How to create a clinical trial budget Physical exams and medical assessments Office visits Lab work, radiology, cardiology and other medical procedures (professional fees) Pharmacy dispensing and drug administration Room charges and hospital bed Determine standard of care items (as needed)

How to create a clinical trial budget Medical supplies Film duplication Study drug storage facilities (locked cabinet/refrigerator) Telephone contact Patient instruction

How to create a clinical trial budget Administrative costs: Data collection/management/analysis Site visit preparation/Study monitoring/Study queries Office supplies Shipping/dry ice Off site storage Telephone charges

How to create a clinical trial budget Other costs: Investigator fee Study Coordinator fee Subject stipend General Clinical Research Center services

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).xls Budget by frequency..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-format freq template.xls PI initiated budget ..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-format PI Initiated.xls

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!

How CRA can help negotiate the budget Budget Negotiation: Review consent form/schedule of events/protocol Compare to sponsor’s budget template Review 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.

Budget Contacts Diana Naser, Director ext 1242 Kelly Daniels, Assistant Director ext 1484 Clinical Trial Administrators: Molly Gunter ext 5969 Barb Liles ext 5589 Alec Johnson ext 1262 Jody Kittell ext 5705 Kris Keller ext 5718