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

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) hwarren@kumc.edu