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Fund 214: Industry Funded Clinical Trials

7/22/09

This new fund was established to support the University's Industry Sponsored Clinical Trial Business. Fund 214 offers less central administration and more local control. Fund 214 is cash based which matches how we operate clinical trials.

Projects established in Fund 214 will be conducted under the following procedures.

Currently the use of Fund 214 is optional until 6/30/10, at which time an evaluation of the process will be made and, if satisfactory, will become the standard process for all new clinical trials.

If you have helpful suggestions or comments about Fund 214 please email: ufawards@ufl.edu.

Fund 214 Rules

  1. Patient Service Costs must be charged to the appropriate trial project directly at the time of the service or if an unrestricted account was used in advance, such as the administrative operational project, misc donors project or overhead project, those cost must be transferred to the Clinical Trial project as quickly as possible once sufficient revenue has been received.

  2. The earned payments during the life of the clinical trial should be used to support the clinical trial being conducted in accordance with the clinical trial agreement.

  3. Transferring reasonable amounts of earned payments to a clinical trial administrative operating project to cover incidentals and administrative labor to run the clinical trial program of a unit or individual Principal Investigator's trial program will be allowed.

Fund 214 Procedures

Project Set-Up

  1. To have a clinical trial project established in Fund 214 of the University's financial system the Division of Sponsored Research (DSR) needs the following documentation:

    1. Completed Sponsored Projects Approval Form (DSR-1) or Peoplesoft Grants Workflow equivalent (COM requires the use of Peoplesoft)

    2. Fully executed CTA

    3. Institutional Review Board (IRB) approval letter

    4. Provide DeptID that you want the project chartfield to be established in

  2. DSR's Award Administration Office will generate the NOA for $0. In the remarks section of the NOA the DeptID number will be identified as well as the PeopleSoft project number, if any, for reference only. In the Special Program fields of the NOA "214 Fund" will be noted.

  3. The budget period for a clinical trial will equal the trials contractual date or the IRB end date whichever occurs first. Upon IRB renewal and notice to DSR's Award Administration at ufawards@ufl.edu, your project end date will be adjusted accordingly in the accounting system.

  4. The NOA is distributed to C&G Accounting. The NOA is not distributed to the College/Department or PI at this time.

  5. C&G Accounting's NOA set up team will establish the project and the HR account code.

  6. C&G Accounting's NOA set up team will email the DSR's Award Administration Office at ufawards@ufl.edu the project number established for the trial.

  7. DSR's Award Administration Office will add the project number to the NOA and distribute to the PI and the College/Department contact person noted on the NOA.

Invoicing and Payments

  1. We recognize the Principal Investigator and the UF Trial administrative staff are in the best position to know when a payment is owed. In this regard, the University allows the PI and their staff to be responsible for requesting payments, by invoicing their trial sponsors.

  2. In this process please indicate to your sponsor how important it is to include the UF project number on the check or check information so when the payment is received it can be easily and rapidly identified to your project.

  3. All checks are to be named payable to the University of Florida and remitted to;

    University of Florida
    Office of Research Business Office - Clinical Trials
    288 Grinter Hall
    Gainesville, FL 32611-5500

  4. Departments will be responsible for confirming payment has been received.

Fund 214 Payment Log

  1. All payments received will be logged into the Fund 214 Payment Log.

  2. Trial payments are very difficult to identify to a UF project number, regardless of fund, so we ask PI's and project staff to help to identify payments to projects, by frequently visiting the Payment Log, especially when you know a payment is due.

  3. When you identify a payment that needs to be applied to your project or you see a correction that needs to be made please contact Amber Krantz. Amber manages the log and check deposit process for Fund 214.

Deposits and Spending Authority

  1. When the Office of Research Business Office-Clinical Trials receives payment, and the project has been identified, a deposit transmittal is prepared and sent to University Cashier, Room S-113 Criser Hall for posting.

  2. The deposit will result in 80% of the payment being credited to the Project for spending with the other 20% released to the DSR indirect cost project for end of year distribution.

  3. Payments not identified to a clinical trial project will be deposited to DSR's holding project until such time a trial project is identified.

DSR's NOA

  1. DSR will issue an NOA establishing the project at $0, as detailed above under project set-up.

  2. As a communication tool, NOA's will be issued for each payment received, deposited and credited to a project in fund 214. The NOA will be after the fact of deposit and credit to the project. The NOA be distributed only to the PI and dept NOA contact person.

  3. Additional NOA's will be issued by DSR for administrative changes to the project such as: change in Principal Investigator, Deptid, Date changes, contractual changes.

Clinical Trial Extensions

  1. Upon request or notification to DSR's Award Administration Office at ufawards@ufl.edu, two types of internal extensions for clinical trials can be granted;

    1. To accommodate the IRB renewal

    2. To accommodate an administrative close of a trial, generally a 3-month period, where no further human subject activity will take place.

  2. All other extensions would require sponsor approval by a clinical trial amendment.

Clinical Trial Close-Out

  1. Upon the expiration of a clinical trial, the Close Out Procedures for Industry Clinical Trials will apply.

  2. Upon close of a trial any cash balance remaining, DSR with the completed fixed price close memo can approve the direct component of the cash be transfer to the PI's miscellaneous donor project and/or a clinical trial operations project where the funds may be spent at their discretion in support of research.

  3. If your trial has ended prior to the accounting system known end date please contact C&G Accounting or DSR at ufawards@ufl.edu and request the close out process begin.

  4. Trials that remain at $0 after 24 months will be closed by C&G Accounting in coordination with DSR.

Trial Never Started

  1. Where a sponsor closed the trial before you are able to enroll a subject, you should immediately request a reasonable amount to cover your startup costs. In the past with DSR approval we have allowed small sums to be deposited in a misc donor's project without assessment of idc.

  2. Contact DSR's Brian Prindle with particulars so we may assist and decide what project the payment shall be deposited to.

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