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KUMC Research Institute How to Create a Clinical Trial Budget Clinical Research Administration October 15, 2007.

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Presentation on theme: "KUMC Research Institute How to Create a Clinical Trial Budget Clinical Research Administration October 15, 2007."— Presentation transcript:

1 KUMC Research Institute How to Create a Clinical Trial Budget Clinical Research Administration October 15, 2007

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 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)

4 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

5 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?)

6 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)

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

8 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

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

10 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..\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..\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..\BUDGETS\3 BUDGET HELP FOLDER\CPTcode-bud-format PI Initiated.xls

11 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!

12 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.

13 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


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