1 / 15

KUMC Research Institute

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.

sundari-chirag
Télécharger la présentation

KUMC Research Institute

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  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) hwarren@kumc.edu

More Related