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
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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