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UUSOP-13: Clinical Research Institutional Fee Schedule

Version Date: July 1, 2024

  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. Fees are inclusive of F&A unless otherwise stated.

 

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:
      • $4,860 one-time
    3. IDS Pharmacy Drug Destruction:
      • $486 one-time at setup
    4. IDS Pharmacy Protocol Amendment:
      • $284 per occurrence (Tier 1)
      • $1,890 per occurrence (Tier 2)
    5. IDS Pharmacy Maintenance:
      • $135 monthly (one drug)
      • $68 monthly (per additional item)
      • $250 per hour (if applicable)
    6. IDS Pharmacy Special Drug Handling:
      • $1,013 one-time (if applicable)
    7. IDS Pharmacy Concomitant Medication Check:
      • $304 per occurrence
    8. IDS Treatment Plan Development:
      • $446 per oncology treatment arm (if applicable)
    9. IDS Pharmacy Special Monitoring:
      • $743 one-time (if applicable)
    10. IDS Pharmacy Additional Paperwork:
      • $122 per occurrence
    11. IDS Satellite Site Transfer fee:
      • $156 per occurrence
    12. IDS Pharmacy Closeout:
      • $1,047 one-time
    13. Laboratory Setup:
      • $1,350 one-time
    14. Specimen processing management fee:
      • $800-$1,600 quarterly
    15. Radiology Setup:
      • $2,700 one-time
    16. Radiology Maintenance:
      • $200 quarterly
    17. Radiological Drug Research Committee and Human Use Subcommittee:
      • $2,300 one-time
    18. Phantom Imaging:
      • $2,700 per scan
    19. De-identification/CD/Upload of Images:
      • $150 per occurrence
    20. Shared Investigator Platform Setup
      • $2,457 one-time
    21. Shared Investigator Platform Maintenance:
      • $534 quarterly
    22. Ancillary Services Sponsor Required Protocol Training:
      • $750 per occurrence
    23. Sponsor specific equipment maintenance & storage:
      • $250 quarterly
    24. Safety Event Reporting and Follow-up:
      • $621 per event
    25. Pregnancy Follow-up:
      • $150 per hour
    26. IND External Safety Reports:
      • $240 per report (after first 10 reports)
    27. Participant Travel Reimbursement:
      • Current IRS business mileage rate plus F&A
    28. Participant Hotel Reimbursement:
      • Up to $250 per night plus F&A
    29. Participant Payments:
      • $2.05 Debit Card (initial)
      • $1.10 Debit Card (per transaction)
      • $2.70 Direct Deposit (per transaction)
      • $2.05 Debit Card (replacement)
    30. Budget Translation Fee:
      • $3,500 per protocol version
    31. Institutional Oversight Fee:
      • $8,190 quarterly
    32. Primary Children’s Hospital Board Review:
      • $2,089 one-time
    33. Center for Quantitative Cancer Imaging:
      • $1,365 one-time
    34. CTSI Application Submission and Startup:
      • $1,350 - $4,050 one-time
    35. Cell Therapy and Regenerative Medicine Startup:
      • $4,725 one-time
    36. CTSI Biomedical Informatics Core 21 CRF Part 11 Compliance Maintenance:
      • $3,375 one-time

 

Materials Required 

 

Document Approval 

Erin Rothwell Ph.D.
Vice President for Research, University of Utah
DATE: July 5, 2024

 

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

01Jul2024

Fiscal year 2025 rate and fee changes

 

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

Last Updated: 7/11/24