Study Activation

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Budget

Definition

  • The Budget governs study reimbursement. An industry-sponsored clinical research study budget is typically comprised of: (1) a section encompassing UMMC's per-participant, per visit costs, and (2) UMMC's invoiced administrative fees.

Policies/guidelines

  • Budgeting practices differ based on whether the study sponsor is a governmental entity or industry. Your Office of Clinical Trials (OCT) contract and budget negotiator will provide guidance on the applicable budgeting practices for a particular study.
    • Federally-funded studies may be cost-reimbursement, where UMMC is reimbursed for costs plus overhead, or fixed-price, where UMMC is reimbursed a set amount per participant, regardless of UMMC's costs. UMMC charges a 55% overhead rate for on-campus clinical research studies.
    • Industry sponsors are charged a 31% overhead rate for all clinical research studies.
  • The bullet points below illustrate the budgeting process for industry sponsored clinical research studies:
    • OCT negotatiator creates cost analysis and sends to the study team (3 business days)
    • Study team reviews and provides non-standard of care billing codes
    • OCT negotiator adds non-standard of care pricing to the cost analysis and submits budget response to sponsor/CRO (3 business days)
    • OCT negotiates budget with sponsor/CRO until finalization (2 business days per party, not to exceed 30 calendar days)

TEMPLATES/FORMS