Clinical Trial Agreement Fact Sheet

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:

• Research Institute Administrative fee**: The fee includes complete administrative study set-up, regulatory document collection and filing, study communications, budget preparation, and contract review.
• 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 expenses for the IRB support staff.
• Principal Investigator Hours*: Protocol review, study subject review, time spent with study subjects for obtaining consent and study-related activities, meetings, phone calls.
• 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and Study Coordinator hours are still payable even if the study does not proceed at KUMC i.e. is cancelled or withdrawn.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, MS, CCRP Division Director at 913-588-5969.
Revised 7/1/2011

Investigational Drug Services (IDS) Fee Schedule - July 2011 

* A $700 set-up fee assumes a study of moderate complexity, based on IDS staff determination; this fee may be increased to $900 for a high complexity study or decreased to $500 for a low complexity study
** A lengthened or complex chemotherapy preparation process involves preparation time > 30 minutes, handling of any gene therapy product, or any other such procedures that exceed standard chemotherapy preparation based on IDS staff determination
*** Fee includes relabeling, inventory, expiration date monitoring, protocol amendments and other ongoing study procedures that are necessary regardless of subject enrollment

Definitions:
After-hours Fee - Includes IDS on-site involvement between the hours of 6pm-8am for the purposes of randomization, dispensing (if necessary), monitoring labs/drug levels, or other such required procedures that cannot take place during normal working hours. 

Close-out Fee - Includes everything involved in the close-out of the study, including attendance at the Close-out Visit, final disposition of drug along with required paperwork, and preparation for long-term storage and associated fees with such storage. 

Dispensing Fee - Includes all work that goes into the preparation of the finished product; this may include, but is not limited to, IVRS/IWRS involvement, required paperwork, accountability, aseptic procedures involved in IV preparation, and labeling. For chemotherapy studies this fee also covers cytotoxic handling and ongoing disposal. 

Set-up Fee - Includes everything involved in the start-up of the study, including familiarization with the protocol, pharmacy manuals and other study materials, attendance at the Site Initiation Visit, training of pertinent staff, acquisition of additional study materials not supplied, and development of investigational procedures/materials, such as database entries or nursing training  documents. For chemotherapy studies, this fee also covers protocol build and maintenance in Beacon, the oncology module in O2.