Clinical Trial Agreement Fact Sheet
| Payee Name | KUMC Research Institute, Inc. Not For Profit 501(c)(3) |
| Payee Address | University of Kansas Medical Center Research Institute, Inc., Mail Stop #1039 3901 Rainbow Boulevard Kansas City, Kansas 66160-7702 |
| Notices to | Greg S. Kopf, PhD Executive Director, Research Institute |
| Mail Contracts to | Molly Gunter Director, Clinical Research Administration |
| University/Federal Institution ID | #48-1108830 |
| Telephone | (913) 588-5969 |
| Fax | (913) 588-5729 |
Clinical Trial Budget:
Please include the following upfront one time fees on Industry Sponsored budgets:
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IRB submission/review fee: $2500
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IRB recertification fee: $1500 per recertification annually
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Amendment fee: $1200 per IRB full board amendment
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KUSM-Wichita IRB one time administrative fee: $1000
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Research Institute Administrative fee: $1500
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Pharmacy Opening/Closing Fee (when applicable): is attached on a separate sheet
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Archival Storage fee (when applicable): approx $560 plus overhead
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Principal investigator hours: $200 per hour (exceptions may apply)
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Study coordinator hours: $75 per hour
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Audit fee (regardless of cause): $1000 per day for Sponsor generated audits/ $2,000 per day for FDA generated audits
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Other Administrative fees may apply
$5000 is non refundable Investigator administrative fee which includes, but is not limited to:
- start up costs for time spent by the PI and other staff
- database training
- regulatory documentation preparation, consent form review, fax, mail
- monitoring visits
- continued maintenance of site regulatory and subject binders
- initial investigator/staff training, continuing training, web training sessions
- protocol/database/web training for additional study personnel after initiation
- use of equipment
- conducting site selection & site initiation visits
- resources and space for monitoring visits
- review and ordering preparations for drug, lab and equipment inventory
- recruitment efforts
- Ongoing regulatory/IRB requirements/processing (ie RCRTs, SAEs, revised 1572s etc)
NOTE: Administrative fees may apply
Facilities and Administration (F&A) Rate
Privately funded F&A: 33%
Federal F & A: All other research and sponsored programs will be assessed at the current federally negotiated rate in effect at the time of award acceptance.
Fee Definitions:
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Administrative fee**: The fee includes complete administrative study set-up, regulatory document collection and filing, study communications, budget preparation, and contract review.
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IRB fee**: This fee includes protocol review by the Clinical Research Administration Division, consent form preparation, University of Kansas Medical Center (KUMC)/Western (WIRB) IRB submission and funding for education/training opportunities for IRB members and administrative expensese for the IRB support staff.
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Principal Investigator Hours*: Protocol review, study subject review, time spent with study subjects for obtaining consent and study-related activities, meetings, phone calls.
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Study Coordinator Hours*: Study set-up, subject review, time spent with study subjects for obtaining consent and study-related activities, meetings, site and monitoring visits, protocol, education, case report form completion, travel to investigator meetings and other study-related activities.
**Administrative fees, IRB fees, Principal Investigator and Study Coordinator hours are still payable even if the study does not proceed at KUMC i.e. is cancelled or withdrawn.
The Research Institute is the contracting and fiscal entity for privately sponsored research at The University of Kansas Medical Center. The Clinical Research Administration Division of the of the Research Institute is a central office that assists investigators with consent form preparation, IRB submission, regulatory documents, budgets and contract review. For initial questions, please direct them Molly Gunter, Interim Division Director of Clinical Research Administration at 913-588-5969.
Revised 7/1/2011
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