Budgeting Resources

The Office of Clinical Trial Activation provides tools for study teams to use when OCTA is not preparing the full study budget (e.g. non-profit studies, grant-funded studies, financial feasibility, or budgets developed by the study department). It is important to consider the different components of a clinical trial budget, such as site administrative fees, per-patient costs, and other variable items and services. The budgeting resources on this page should be used in coordination with the patient care costs on the Research Fee Schedule page. These resources are specific to UCSF Campus sites; and there may be additional cost considerations for affiliates and other locations.

Keep in mind that certain fees may not be allowed based on the funding source, and fees can vary depending on the flow of funds or the type of sponsor.  For more information, please refer to the provided links and contact the appropriate unit if you have any questions regarding the fees.

If you are preparing a clinical trial budget outside of OCTA, we recommend completing CTO 204: Clinical Trial Budgeting Guidance & Concepts before using the available resources.

On this page:

 

 

Research Fees & Items to Budget

 

Site Administrative Fees

Per-patient Costs

Invoiceable Procedures

Study Personnel Effort
  • Start-up
  • Annual maintenance
  • Close-out
  • Fees to recoup effort
  • Hours per role, per patient visit
  • As needed for effort-based items & services

Clinical Research Billing Compliance*

  • Initial
  • Protocol amendments
  
Institutional Review Board (IRB)*
  • Initial review
  • Continuing reviews
  • Modifications

 

 

Investigational Drug Service (IDS)*

- IDS Intake Request Form

  • Start-up
  • Annual maintenance
  • Close-out
  • Consultations
  • Dispensing fees
  • Drug Procurement Costs
  • Costs for treatment regimen only (pre- or post-medications not available for estimates)
  • Pricing is per package, not per dose (e.g., per vial, per bottle)
  • Charges accrued upon procurement and no reimbursements available once purchased
  • Costs subject to change based on current drug prices and availability
  • As needed

Cell Therapy Laboratory (CTL)
 - Adult CTL (ACTL) Laboratory
 - Pediatric CTL (PCTL) - Email for estimate

  • Start-up
  • Annual maintenance
  • Monitoring
  • Apheresis, product pack, ship, cryopreservation.
  • IP receipt, wash, thaw, storage.
  • As needed

Participant & Caregiver Reimbursement

  

Participant Payment

 

Study Document Translation and Interpreter Services†

  • Pass-through plus F&A
  

Clinical & Translational Science Institute (CTSI)*

- Clinical Research Services (CRS), 

- Biospecimen Processing Lab (BSPL), and

- Community and Clinical Research Center (CCRC in Pride Hall)
 

Non-industry funding: Submit Inquiry Form

 

  • Start-up
  • Sample processing and nursing
  • As needed
Participant Recruitment
 - CTSI Consultation Services (CS)*		  
Biostatistics, Community Engagement, 
Study Design & Academic Research Services (ARS)
 - CTSI Consultation Services (CS)*
  • Services include Biostatistics; Study Design; Anti-racism Research*; Community Engagement strategies*; ARS including clinical data extraction
  • Start-up
  • Ongoing
  

Radiology & Biomedical Imaging

  • Clinical Imaging Core Services
  • Clinical Imaging Core Services
  • As needed
Document Storage & Archiving
  • Close-out
  

Please note, some departments/divisions or organized research units (ORU) develop their own fees or administrative assessments. Please contact your department/division or ORU administrator to confirm if this is applicable to your study and how to incorporate into your budget.

*Fees may vary or be waived depending on industry vs. non-industry funding. Consult individual unit fee schedules.

†Aligns with UCSF Equity in Research initiative

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Indirect Rates

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