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Office of Research and Development

Office of Research and Development
The Queen’s Medical Center
1301 Punchbowl Street, UHT 508
Honolulu, Hawaii 96813

Business-Related Services

Research Business Office (RBO)

The Research Business Office (RBO) provides services to investigators in various scopes, some of which are: trial agreement and budget development & execution; and fiscal and administrative support of Industry-Sponsored studies.

Fiscal and Administrative Support

  • Reviews and accepts awards on behalf of The Queen's Medical Center (QMC)
  • Establishes required financial accounts at QMC
  • Manages revenues and expenses
  • Ensures compliance with sponsors' fiscal terms and conditions
  • Provides financial reports to investigators

Clinical Trial Agreement Development & Execution

  • Reviews and finalizes agreement between sponsor and QMC
  • Negotiates study budget with sponsor
  • Collaborates with study sponsor and principal investigator

Schedule of Fees

The following are The Queen’s Medical Center’s start-up and ongoing fees for clinical trials. Inclusive of overhead, final fees are subject to contract negotiation. All start-up fees are assessed independent of IRB approval or subject enrollment and are non-refundable.

Please note that in addition to the business fees, your study will also occur IRB related fees. All fees are subject to change.

  • Administrative Start-up – $3,000
    • To cover Business Office effort in review, negotiation and execution of contract and budget; setup study in Clinical Trial Management System
    • Study subscription fee
    • Study Coordinator and Research Staff’s effort in working with Business Office related to contract and budget.
  • Coverage Analysis – $1,500
  • Investigator Meetings – $3,000 (Principal investigator and study coordinator time spent traveling and attending meetings)
  • Site Initiation – to be determined per study
  • Study Setup and Maintenance in CTMS – $2,000
  • Regulatory Study Startup (Research Coordinator) – to be determined per study
  • Pharmacy Set-up – $4,000
  • Lab Start-up Fees – $300
  • Overhead – 35%
  • Serious Adverse Event Reporting, per hour (based on PI and Coordinators hourly rate)
  • Screened Failed – to be determined per study
  • Re-Consenting Fee, per hour (based on PI and Coordinators hourly rate)
  • Remote/On-site Monitoring – $955
  • Setup of Remote Monitoring Access in EPIC, per – $398
  • Monitor Change Fee, per – $405
  • Annual Study Subscription (CTMS) – $600 (**subject to annual increase)
  • Annual Study Maintenance – to be determined per study
  • Annual Document Storage fee – $500
  • Pharmacy dosing/dispensing fee – to be determined per study
  • Coverage Analysis per Protocol Amendment (Sponsor-Initiated) – $1,500
  • Contract Amendment Admin Fee (Sponsor-Initiated) – $2,500
  • Training due to Amendments (Sponsor-Initiated), per hour – $80
  • IRB Submission Preparation Fee, per submission – $500
    • Fee for the work performed for the preparation and submission of IRB submissions associated with initial, resubmissions or revisions of the Protocol, Informed Consent Documents, annual review, or reviews required for closure of the Study
  • Study closure fee – $2,239
  • Pharmacy Close-Out Fee – to be determined per study
If you have any questions, please contact:

Sheila Dela Cruz
Manager, Research Business Office
Phone: 808.691.7409
Fax: 808.691.5079
E-mail: sdelacruz@queens.org

The Queen’s Medical Center
Office of Research and Development
1301 Punchbowl Street
UHT 508
Honolulu, Hawaii 96813

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Uniform Guidance

RE: DECLARATION OF PROCUREMENT STANDARDS

The Queen’s Medical Center (QMC) hereby elects to utilize the grace period established in the Office of Management & Budget Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; final Rule – 2 CFR Chapter I, Chapter II, Part 200, et al. also known as the Uniform Guidance (UG) for July 1, 2015 (FY 16) and continue use of Circular A-110.

Excerpt from § 200.110 (a): “For the procurement standards in §§ 200.317 – 200.326, non-Federal entities may continue to comply with the procurement standards in previous OMB guidance (superseded by this part as described in § 200.104) for two additional fiscal years after this part goes into effect. If a non-Federal entity chooses to use the previous procurement standards for two additional fiscal years before adopting the procurement standards in this part, the non-Federal entity must document this decision in their internal procurement policies.”

In the meantime, QMC shall modify and develop procurement procedures to become consistent with the Uniform Guidance. QMC shall be in compliance with the UG effective July 1, 2018 (FY 19).