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Clinical Trial Agreement Processing Guide
The University of Florida’s faculty and staff participate in numerous clinical trial projects, studying investigational drugs or devices.
DSR is responsible for reviewing, negotiating and legally executing agreements from external funding sources in support of these activities. The negotiation and resolution of many contractual issues requires coordination between the trial’s sponsor, the Principal Investigator, Study Coordinators, and DSR. The involvement of each party is essential to a successful Clinical Trial Agreement with mutually acceptable terms.
Processing your Clinical Trial Agreements (CTA) through DSR:
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The Principal Investigators (PI) or designee should provide DSR’s Proposal Processing Office with a copy of the proposed CTA, a copy of the protocol, DSR’s Clinical Trial Checklist, and a company contact person as early in the process as possible.
To expedite the review and negotiation process receiving these documents or at least the CTA in electronic form is best. The PI or sponsor representative can deliver agreements electronically to ufproposals@research.ufl.edu.
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DSR can begin negotiations, but cannot execute the CTA until the completed Sponsored Projects Approval Form (DSR-1) or Peoplesoft Grants equivalent is received as well as any other appropriate information which would be conveyed to the PI by DSR during negotiations.
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IRB approval is not necessarily required for DSR to execute an agreement, but certainly is required prior to commencing work under the CTA.
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Once the terms of the CTA have been negotiated and the Sponsored Projects Approval Form is on file along with any other need information DSR will sign the Agreement and return it to the company contact, unless otherwise directed.
If the Investigator’s signature is needed to acknowledge the terms of the agreement, DSR will collect such signature prior to signing and returning the CTA to the company.
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Once DSR receives a fully executed CTA, a copy will be sent to the PI for their records.
IRB must be obtained prior to commencing work and enrolling patients.
DSR will release spending authority upon receipt of payments. Spending authority for clinical trials always equals the amount of cash received.
Note: Your department or college may have additional requirements which are not listed above.
Contractual Elements of a CTA
Each CTA is reviewed on a case-by-case basis, however there are a number of contractual items that are common to most CTA agreements. The following is a sample of common elements of a CTA that will be negotiated by DSR with the Sponsor:
If the UF Clinical Trial Checklist identifies that the sponsored study is supported by the VA or conducted at a VA facility or targets VA subjects then DSR must include VA approved contract language in the CTA. This is one of UF`s roles to help the VA obtain AAHRPP accreditation. (top)
Parties to the Agreement
The parties to the Agreement should be by and between the University of Florida and the Sponsor. The Investigator as an employee of the university should not be named as a legal party to the Agreement. We do allow the Investigators to sign CTA’s as Read and Acknowledged if the Sponsor insists. (top)
Publications
Agreements must allow the Investigator the ability to publish results of the study. We do afford the sponsor a right of prior review for purposes of identification of proprietary or confidential information or intellectual property protection. Where UF is one site of a multi-site trial we do allow sponsors to coordinate timing of publications among the sites. (top)
Publicity
The University of Florida does not allow the sponsor to freely use our name or the name of the University’s project staff in any publicity, advertising, or press release without the express prior written approval of an authorized representative of University. (top)
Intellectual Property
The drug or device being tested in the clinical trial is normally proprietary and owned by the sponsoring party and may already be covered by patent protection. Although each CTA must be reviewed on its own merit, it is the University of Florida’s general policy that title to inventions arising from projects conducted by faculty and staff will be owned by the University. (top)
Indemnification
The sponsoring party, and the actual owner of the study drug or device if an intermediary is involved, must agree to indemnify and hold harmless the University of Florida from any and all liabilities, claims, actions or suits for personal injury or death arising from the conduct of the CTA.
The University of Florida cannot provide indemnification. (top)
Governing Law
Agreements should be governed by the laws of the State of Florida or this provision must be absent from the agreement. (top)
Subject Injury Compensation Language
It is DSR procedure to negotiate appropriate compensation language for subject injury in all CTA's. The language should be similar to one of the variations vetted and approved by UF General Counsel.
Clinical Trial Master Agreements
The University has entered into many Clinical Trial Master Agreements. Master Agreements provide agreed-upon terms and conditions of a basic relationship between the University and a Sponsor. Once a Master Agreement is in place, a "study letter" is generated for each new study to be done under the Master Agreement. The study letter sets forth the conditions of a certain study such as dollar amount, protocol name, and principal investigator.
Below is a list of Clinical Trial Master Agreements currently in place with DSR. When working with any of the following sponsors, you may mention that we do have a Master Agreement. This may help in facilitating your project by not having to negotiate.
Alexion Pharmaceuticals, Inc
American College of Radiology
Amgen, Inc
Bayer Pharmaceutical Division
Baxter Healthcare
Biogen Idec, Inc
Biogen
Bristol Myers-Squibb
Boehringer Ingelheim
Cephalon, Inc
Childrens Mercy Hospital
Cook Incorporated
DuPont Pharmaceuticals Co.
Eastern Cooperation Oncology Group
Esai Medical Research
Fulcrum
Galileo Laboratories
Glaxo Smith Kline
GSK
Intermune, Inc
Merck
Merck (Agreement 206093)
Millennium
Moffitt Cancer Center
Nonivasive Medical Technology
Novartis Pharma AG
Novartis Pharmaceuticals
Noven Pharmaceuticals, Inc
Ortho Biotech
Pfizer
Pharmacyclics, Inc
Pharmassett
RW Johnson Pharma Research Institute
Roche Bioscience
Roche Bioscience/Roche Global
Sanofis - Aventis US
Schering-Plough Research Institute
SC Liver Research Consortium
TAP Pharma
Vertex Pharmaceuticals
Wyeth Pharmaceuticals, Inc
(top)
Budgets
Clinical studies are usually funded on a per-patient basis with provisions for pro-rated payment for patients who do not complete the study. All costs necessary to conduct the study, including salaries, procedures, services, supplies and indirect costs, should be considered when determining the fixed per-patient amount. (top)
Sponsors usually use one of two options when presenting a budget. They may offer a certain amount per patient and ask that you work within that amount or they may ask you to formulate a budget for them. Regardless, it is the principal investigators responsibility to ensure that the amount agreed upon will adequately cover all costs associated with conducting a clinical trial. (top)
Budgeting Indirect Costs
Indirect costs (IDC) for non-federal clinical trials at the University of Florida have a set indirect cost rate of 25% of total direct costs (TDC). When budgeting, add 25% of the direct costs to your total. Example; $1,000 of direct x 1.25% = $1,250 total cost. (top)
Indirect Cost Recovery
When payment is received indirect costs are assessed at the flat rate of 25% of actual cash received. For example a $1,250 payment is received from a clinical trial sponsor. The funds are credited to your project as follow; $1,250/1.25 = $1,000 Direct Cost and $250 of Indirect Costs. The direct component is the amount available to the PI to cover project costs. (top)
WIRB IRB Fee
All investigators submitting commercial sponsored Clinical Trials are required to use WIRB (IRB-04). The WIRB fees may be charged directly to the commercially sponsored CTA, or the sponsor may elect to pay WIRB directly. All other clinical trials are reviewed by the University’s appropriate IRB office which does not charge a fee for their service. (top)
Taxpayer ID Number (TIN) W-9 Forms
DSR will prepare W-9 forms when requested by sponsors. This form requires official institutional signature. The University of Florida’s Taxpayer ID Number (TIN) is 59-6002052. (top)
Clinical Trial Project Set-up
To have your clinical trial project established in the University’s financial system with spending authority the following documentation is required;
A completed and signed Sponsored Projects Approval Form (DSR-1) or Peoplesoft equivalent
Institutional Review Board (IRB) approval letter
Initial payment received from the Sponsor
For additional payments to be credited to your project either the PI or Contracts and Grants Accounting must forward a copy of the check with any other correspondence to DSR’s Award Administration Office and request a Notice of Award Acceptance (NOA) be issued. (top)
Spending Authority
Spending authority for clinical trials will always equal amount of payment received. The budget period for a clinical trial will equal the trials contractual date or the IRB end date which ever occurs first. (top)
Clinical Trial Invoicing and Payments
We recognize the trial’s Principal Investigator and administrative staff take responsibility for trial invoicing as they are in the best position to know the particulars. A copy of the invoice should be sent to the University’s Contracts and Grants Accounting Office so they may enter a receivable into the University financial system. Invoices should reference the University Project number and provide instruction to have our sponsor include on the check for easy identification once received. All checks are to be named payable to the University of Florida and mailed to C&G Accounting, PO 113001, 302 Tigert Hall, Gainesville, FL 32611-3001. (top)
Trial Never Started?
When a trial is closed before you are able to enroll a subject, no payment will be received and you have incurred costs that will not be reimbursed. If this is the case, ask the CTA sponsor for a reasonable payment that will cover your startup costs. This amount should be adequate to cover all costs you incurred for initiating the trial in good faith. Contact DSR with particulars so we may assist. (top)
Clinical Trial Amendments
An amendment changes the terms of a previously executed agreement. Amendments may be monetary, non-monetary or both. Amendments to CTA’s must be reviewed, approved and executed by the legal authorities at the Division of Sponsored Research (DSR). In most cases a Sponsored Projects Approval Form (DSR-1) is not required. Simply fax, email, or send a hard copy of the amendment to DSR for processing. (top)
Clinical Trial Extensions
Upon request or notification to DSR’s Award Administration Office two types of internal extensions for clinical trials can be granted as follows;
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to accommodate a new end date up to the contractual end date based on the IRB’s renewal, and
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to accommodate an administrative close of a trial, generally a 3-month period, where no further human subject activity will take place.
All other extensions would require sponsor approval by a clinical trial amendment. (top)
Clinical Trial Close-Out
Upon the expiration of a clinical trial, the University’s Contracts and Grants Accounting Office will issue a fixed price close memo to the PI which provides an account of payments and expenditures. If there is a cash balance remaining and the expenditures incurred to conduct the trial are reasonable in relation to the amount of payment received, DSR with the completed close memo can approve the direct component of the cash be transfer to the PI’s miscellaneous donor project where the funds may be spent at their discretion in support of research. (top)