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UUSOP-13: Clinical Research Institutional Fee Schedule

Version Date: October 5, 2023

  1. Introduction and Purpose
  2. Definitions and Acronyms
  3. Fees
    1. Standard Fees
    2. Additional Fees
  4. Materials Required
  5. Document Approval
  6. Revision History

 

The scope and purpose of this SOP is to set forth requirements for the conduct of industry sponsored clinical trials within the University of Utah. This SOP may be used to guide the conduct of other types of clinical research studies to promote standardization and proper clinical research billing compliance practices.

 

Introduction and Purpose 

The Clinical Research Institutional Fee Schedule is set forth as a standardized cost structure to be utilized when participating in industry sponsored research. Fee standardization within the University of Utah promotes consistency and assists in adhering to proper research billing compliance. The fees described below are calculated with the University's F&A charges included, unless where otherwise stated in items 2.26 and 2.27. Therefore, research teams should not charge additional F&A fees in their budget for the items described below. For additional information regarding F&A fees, please refer to the Office of Sponsored Projects.

 

Definitions and Acronyms 

Clinical Research: Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.

Clinical Trial: Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.

CMS: Centers for Medicare & Medicaid Services
CTMS: Clinical Trial Management System
CTO: Clinical Trials Office
GCP: Good Clinical Practice
HIPAA:        Health Insurance Portability and Accountability Act
IDE: Investigational Device Exemption
IDS: Investigational Drug Services
IND: Investigational New Drug
IRB: Institutional Review Board
PI: Principal Investigator
SAE: Serious Adverse Event
SIV: Site Initiation Visit
SOP: Standard Operating Procedure

 

 

  1. Standard fees (applicable to all protocols): 
    1. Administrative Start-up:
      • $6,750 one-time (minimal risk studies, i.e., observational, non-interventional, retrospective chart review)
      • $10,800 one-time (all other studies)
    2. Clinical Trials Office Fee:
      • $6,750 one-time (minimal risk studies)
      • $12,000 one-time (all other studies)
    3. IRB Initial Submission and Review:
      • $8,100 one-time (local)
      • $5,100 (central)
    4. IRB Amendment Fee:
      • $3,240 per occurrence (local – includes prep and submission)
      • $2,040 (central)
    5. IRB Annual Review Fee:
      • $2,560 annually (local – includes prep and submission)
      • $1,360 annually (central)
    6. IRB Closeout Submission:
      • $2,200 one-time
    7. CMS Coverage Analysis:
      • $1,675 one-time (non-IDE trials)
      • $2,184 one-time (IDE trials with sponsor submission to CMS)
      • $4,095 one-time (IDE/IND trials with site submission to CMS)
    8. CTO/Department Maintenance:
      • $2,500 quarterly
    9. Excessive Monitor Change:
      • $1,425 (2nd change and each time thereafter)
    10. Monitoring Visit:
      • $918 per day
    11. Remote Based Monitoring:
      • $1,350 per event
    12. Pre-screening/Recruitment:
      • $150 per hour
    13. 1.13. Outside Agency Audit (not for cause):
      • $1,350 per day
    14. Participant Re-consent:
      • $150 per occurrence
    15. Research Infrastructure Fee:
      • $90 per hour
    16. Foreign Language Translation:
      • $0.20 per word
    17. Foreign Language Onsite Interpretation:
      • $150 per hour
    18. Principal Investigator Effort:
      • $496 per hour
    19. Research Nurse Effort:
      • $316 per hour
    20. Research Dietician Effort:
      • $295 per hour
    21. Research Coordinator Effort:
      • $170 per hour
    22. Document Archival and Storage:
      • $675 per year (length of storage is per contract or protocol, whichever is longer)
    23. Site Closeout:
      • $2,700 one-time
  2. Additional fees (based on specifics of protocol) 
    1. CTMS Fees (i.e., OnCore):
      • $5,400 one-time start-up
      • $2,700 annual maintenance
    2. IDS Pharmacy Setup:
      • $4,658 one-time
    3. IDS Pharmacy Drug Destruction:
      • $473 one-time at setup
    4. IDS Pharmacy Protocol Amendment:
      • $270 per occurrence (Tier 1)
      • $1,823 per occurrence (Tier 2)
    5. IDS Pharmacy Maintenance:
      • $135 monthly (one drug)
      • $61 (per additional item)
    6. IDS Pharmacy Special Drug Handling:
      • $1,013 one-time (if applicable)
    7. IDS Treatment Plan Development:
      • $439 per oncology treatment arm (if applicable)
    8. IDS Pharmacy Special Monitoring:
      • $709 one-time (if applicable)
    9. IDS Pharmacy Additional Paperwork:
      • $103 per occurrence
    10. IDS Satellite Site Transfer fee:
      • $149 per occurrence
    11. IDS Pharmacy Closeout:
      • $1,013 one-time
    12. Laboratory Setup:
      • $1,350 one-time
    13. Specimen processing management fee:
      • $800-$1,600 quarterly
    14. Radiology Setup:
      • $2,700 one-time
    15. Radiology Maintenance:
      • $200 quarterly
    16. Radiological Drug Research Committee and Human Use Subcommittee:
      • $2,300 one-time
    17. Phantom Imaging:
      • $2,700 per scan
    18. De-identification/CD/Upload of Images:
      • $150 per occurrence
    19. Shared Investigator Platform Setup
      • $2,457 one-time
    20. Shared Investigator Platform Maintenance:
      • $534 quarterly
    21. Ancillary Services Sponsor Required Protocol Training:
      • $750 per occurrence
    22. Sponsor specific equipment maintenance & storage:
      • $250 quarterly
    23. Safety Event Reporting and Follow-up:
      • $621 per event
    24. Pregnancy Follow-up:
      • $150 per hour
    25. IND External Safety Reports:
      • $240 per report (after first 10 reports)
    26. Participant Travel Reimbursement:
      • Current IRS business mileage rate plus F&A
    27. Participant Hotel Reimbursement:
      • Up to $250 per night plus F&A
    28. Participant Payments:
      • $2.05 Debit Card (initial)
      • $1.10 Debit Card (per transaction)
      • $2.70 Direct Deposit (per transaction)
      • $2.05 Debit Card (replacement)
    29. Budget Translation Fee:
      • $3,500 per protocol version
    30. Institutional Oversight Fee:
      • $8,190 quarterly
    31. Primary Children’s Hospital Board Review:
      • $2,089 one-time
    32. Center for Quantitative Cancer Imaging:
      • $1,365 one-time
    33. CTSI Application Submission and Startup:
      • $1,350 - $4,050 one-time
    34. Cell Therapy and Regenerative Medicine Startup:
      • $4,320 one-time
    35. CTSI Biomedical Informatics Core 21 CRF Part 11 Compliance Maintenance:
      • $3,375 one-time

 

Materials Required 

 

Document Approval 

Erin Rothwell Ph.D.
Interim Vice President for Research, University of Utah
DATE: 10/10/2023

 

Revision History 

Version Date

Change Summary

29Sep2021

Original Version

31Jan2022

Updated to reflect F&A rate change

21Mar2022

Specified "OnCore" as CTMS

31Oct2022

25Jan2023

Addition of mandatory fees related to participant payment (i.e., 2.28)

01Jul2023

Fiscal year 2024 rate and fee changes

05Oct2023

Addition of CTSI Biomedical Informatics fee

 

Printed or photocopied versions are considered unofficial copies unless it is the original signed document.

Last Updated: 3/22/24