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Clinical Trials
The University of Florida's faculty and staff participate in numerous clinical trial projects, studying investigational drugs or devices. This website is designed to provide guidance and information about DSR's Clinical Trial Procedures. HSC faculty and staff must also follow the procedures of the HSC Clinical Trial Compliance Office.
Clinical Trials and Non-Disclosure Agreements Processing Guide
If you need to know how to process a clinical trial or non-disclosure agreement for DSR signature then please go to our Clinical Trials and Non-Disclosure Agreements Processing Guide.
Clinical Trial Master Agreements
Clinical Trial Master Agreements provide agreed-upon terms and conditions establishing the basic relationship between the University and a Sponsor. Once a Master Agreement is in place, a "study letter" or "task order" is generated by the sponsor for each new study to be conducted under the Master Agreement. The study letter sets forth the conditions that are unique to the study, such as dollar amount, protocol name, and principal investigator.
Using a Master Agreement can save time. The current list of fully executed Master Agreements can be found at Clinical Trial Master Agreements.
Fund 214 Industry Sponsored Clinical Trials
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.
For more detail see the Fund 214 Rules, Procedures, and Guidance.
Fund 214 Payment Log
All payments for trials established in Fund 214 projects must be directed to:
University of Florida
Office of Research Business Office - Clinical Trials
288 Grinter Hall
Gainesville, FL 32611-5500
All payments received will be logged into the Fund 214 Payment Log.
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.
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.
For more detail see the Fund 214 Rules, Procedures, and Guidance.
Clinical Trial Project Set-up
To have a clinical trial project established in the University's financial system the following documentation is required;
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Completed Sponsored Projects Approval Form (DSR-1) or Peoplesoft Grants Workflow equivalent
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Fully executed CTA
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Institutional Review Board (IRB) approval letter
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Provide DeptID for projects in Fund 214
Spending Authority
For Fund 209
As payment is received, C&G Accounting will request DSR to authorize the release of budget equal to the payment received. DSR authorizes the release by issuing a NOA.
For Fund 214
DSR will issue a onetime NOA upon full execution of the agreement and IRB approval. A 214 project is initially established at $0. As payments are received and identified to a project, the Office of Research Clinical Trial Business Unit will release 80% of the cash into the project for spending with the other 20% released to the DSR indirect cost project for end of year distribution.
As a communication tool, DSR will continue to issue NOA's 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.
Budget Period
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.
Clinical Trial Extensions
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;
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To accommodate the IRB renewal
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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.
Clinical Trial Invoicing and Payments
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.
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 identify and credit to your project. All checks are to be named payable to the University of Florida and remitted to;
For Fund 214
University of Florida
Office of Research Business Office - Clinical Trials
288 Grinter Hall
Gainesville, FL 32611-5500
For Fund 209
Contracts and Grants Accounting
123 Grinter Hall
Gainesville, FL 32611
Clinical Trial Cash Balance
Coming Soon
Trial Never Started?
When a trial is closed 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.
Contact DSR's Brian Prindle with particulars so we may assist and decide what project the payment shall be deposited to.
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 RAC or DSR for processing, as appropriate.
Clinical Trial Close-Out
Upon the expiration of a clinical trial, follow the Close Out Procedures for Industry Clinical Trials.
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.
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.
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 just a sample of common elements found in a CTA that may need to be negotiated by DSR or RAC with the Sponsor:
- 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.
- 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.
- 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.
- 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.
- Indemnification
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The sponsoring party, and the actual owner of the study drug or device if an intermediary is involved, normally shall provide 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.
- Governing Law
- Agreements should be governed by the laws of the State of Florida or this provision must be absent from the agreement.
- 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.
- VA Approved Contract Language
- If the UF Clinical Trial Checklist identifies that the study is supported by the VA or conducted at a VA facility or targets VA subjects then the CTA must include VA approved contract language. This is one of UF`s roles to help the VA maintain its AAHRPP accreditation.
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.
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.
If you have questions about how to correctly price or budget a clinical trial contact the HSC Clinical Trial Compliance Office.
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.
Indirect Cost Recovery
Yes, UF's idc rate is 25% of total direct costs, however when payment is received indirect costs are assessed at the flat rate of 20% of actual cash received. This concept will be important to understand when using fund 214. Only the direct component is released into the 214 project for spending.
For example a $15,000 payment is received from a clinical trial sponsor. The payment will be split into directs and indirects as follows; $15,000 payment x 20% = $3,000 for indirects, leaving $12,000 for the direct costs.
IRB and WIRB IRB Fee
All investigators are required to use WIRB (IRB-04) for industry sponsored Clinical Trials, unless an exemption is granted by the College of Medicine's Dean's Office. The WIRB fees may be charged directly to the industry sponsored CTA, or the sponsor may elect to pay WIRB directly. If the latter is the case, the WIRB invoice must be sent to the sponsor for payment.
All non-industry funded clinical trials are reviewed by the University's appropriate IRB office which does not charge a direct fee for their service.
ICMJE Clinical Trial Registration Requirement
In September 2004, the International Committee of Medical Journal Editors (ICMJE) announced as a prerequisite to publish study results in ICMJE member journals the clinical trial must be registered with a public registry that meets the ICMJE's minimal registration data set of 20 items.
For the most part the only registry that meets the criteria is ClinicalTrials.gov.
For details and guidance regarding this requirement go to DSR's ICMJE Trial Registration Web page.
NIH Clinical Trial Registration Requirements
Public Law 110-85 (also known as the FDA Amendments Act), enacted on September 27, 2007, amends the Public Health Service Act to mandate registration of "applicable clinical trials" in ClinicalTrials.gov.
As a result the National Institutes of Health (NIH) requires grantees and their investigators to register their "applicable clinical trials" in ClinicalTrials.gov.
NIH Guide Notices, NOT-OD-08-14, NOT-OD-08-023, and NOT-OD-09-030 provide us with the information needed to determine if your trial needs to be registered.
ClinicalTrials.gov
Clinical Trials are registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS).
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The University of Florida has an Organizational PRS registration.
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All trials being conducted at the University of Florida that are required to be registered shall register under the University of Florida's account.
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To register your trial in ClinicalTrials.gov, you must first become a Registered User.
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To become a registered user you simply make a request to DSR's Brian Prindle or Brian Miller our PRS Administrators for the University of Florida.
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In response our PRS Administrator will send you an email (SAMPLE) with your username and login information.
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After you receive the login information, log into the PRS system and complete all the ClinicalTrials.gov data elements and submit.
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The PRS system notifies UF's PRS Administrator to review, approve and release the trial into the Clincaltrials.gov website.
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A ClincalTrials.gov identifier is assigned within 2-5 business days after it is released.
Register Trials must be updated Records for recruiting studies should be reviewed at least once every six months for accuracy and completeness, with particular attention paid to location recruiting status and contact information. After reviewing the record, make any necessary changes, update the record's verification date and release the record.