Transcript University of Kansas Medical Center

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
How to create a clinical trial budget
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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
Investigator Initiated Protocol:
 Data management expenses
 Study-related personnel costs
 Equipment/supply expenses
 Diagnostic fees and services
 Publication costs (preparation of manuscript,
travel, etc.)
How to create a clinical trial budget
Start up Costs:
 Protocol review by Investigator/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.
How CRA can help negotiate the budget
Budget Negotiation:
 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
 Kelly Daniels
Research and Program Officer ext 1484
 Program Administrators:
 Jason Winbolt ext 5709
 Heidi Warren (off site) [email protected]