1. KUMC Research Institute
How to Create a Clinical
Trial Budget
Clinical Research Administration
October 23, 2008
Presented by
Kelly Daniels, CCRP

2. 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

3. 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.)

4. 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)

5. 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

6. 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?)

7. 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)

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

9. 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

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

11. 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

12. 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!

13. 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.

14. 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.

15. Budget Contacts Kelly Daniels Research and Program Officer ext 1484
Program Administrators:
Jason Winbolt ext 5709
Heidi Warren (off site)