Office of Clinical Trials Research

Regulatory Information

All research contracts/agreements, Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA), Data Use Agreements (DUA), Material Transfer Agreements (MTA) and grant applications for awards of external funding must be reviewed and approved centrally by either, the University of Vermont (UVM) Sponsored Project Administration (SPA) or the University of Vermont Medical Center Inc. (UVM Medical Center), Office of Clinical Trials Research (OCTR) as outlined in the institutional affiliation agreement.

For grant applications and contracts which are a) funded federally or by foundations; b) UVM laboratory based research; c) using only University facilities; or d) investigator initiated with an industry sponsor, this process is managed by the Sponsored Projects Administration (SPA) and processed through UVM.

All industry sponsored clinical research agreements, except investigator initiated projects with an industry sponsor, are processed through UVM Medical Center. This process is managed by the OCTR. 

Regulatory Contact

Mark Tomase
Office of Clinical Trials Research
UHC Campus, Arnold 3436
PH 802-656-9914
FAX 802-656-4074

Clinical Trial Agreements, Confidentiality Disclosure Agreements and Data Use Agreements

A Confidentiality Disclosure Agreement, also sometimes referred to as a non-disclosure agreement (NDA), is designed to protect the confidential information that may be released between an industry sponsor and the faculty and staff of UVM/UVM Medical Center so that they can determine whether or not to enter into a subsequent clinical trial agreement.  CDAs may be one-way or mutual and are generally requested by sponsors prior to disclosing a study protocol or other information which the sponsor considers proprietary.  Not all sponsors require a CDA prior to disclosure of confidential information.

OCTR or SPA negotiates and processes all of the CDAs for our organization pertaining to disclosures for prospective research related work that involves UVM/UVM Medical Center faculty, staff, or resources. 

OCTR or SPA representatives are the only parties authorized to sign CDAs on behalf of UVM/UVM Medical Center.  Upon receipt of a CDA, please send the document, along with the contact information from the originating sponsor, to OCTR or your analyst in SPA, so that it can be negotiated with terms consistent with UVM/UVM Medical Center policies and procedures.  

Unless a Master CDA is in place, CDAs are generally project or study specific.   Each specific study or project must be described clearly within each CDA or the work order under a Master CDA to ensure that the description of confidential information is clearly outlined and not ambiguous in the event of a dispute.  

Clinical Trial Agreements are the legally binding agreements between a sponsor and an institution (site) as to how certain business and property rights will be dealt with between the parties. A CTA governs the relationship between the trial sponsor, who provides the device or drug to be studied along with the financial support to do so, and the research institution that will provide study data and results. A clinical trial is defined as a study using human subjects that is determined to question the efficacy of a particular behavior or biomedical intervention, such as a treatment, behavioral strategy, drug, medical device, or nutrition strategy.

The CTA is a legally binding document that governs the allocation of funds, risk, obligations, and responsibility, along with protecting each party's academic, legal, and ethical reputation and intellectual property (IP).

Elements of a CTA include:

• The terms of the collaboration.
  
• The responsibilities of each party.
• Payment and reimbursement procedures and requirements.
• Intellectual property and publication terms.
• Insurance and indemnification.
• Coverage for subject injury.
• Dispute resolution guidelines.
• The procedure for amending contract terms.
• The guidelines to terminate the contract.

The following materials must be sent to OCTR Regulatory Specialist, Mark Tomase:

• Proposed agreement and budget draft.
• Protocol, or draft protocol, narrative description of data to be shared.
• Contact for the person at the external/ collaborating site or organization.

Data Use Agreements are contractual documents used for the transfer of non-public data that is subject to some restrictions on its use.  DUAs serve to outline the terms and conditions of the transfer.  Specifically, DUAs address important issues such as limitations on use of the data, obligations to safeguard the data, liability for harm arising from the use of the data, publication, and privacy rights associated with confidential or protected data. 

In the case where specimens are being shared, we would use a Material Transfer Agreement which would cover sharing of specimens.  In the case of both specimens and data being shared we would use a MTA with DUA terms included.

The following materials must be sent to OCTR Regulatory Specialist, Mark Tomase:

• Protocol, or draft protocol, narrative description of data to be shared.
• Data Management and Security Plan (Fillable Form).
• Data collection forms or specifics about the exact data to be shared. 
• Name of the collaborating site and site PI.
• Contact for the person at the external/ collaborating site (this can be the collaborating site PI).

OCTR or SPA representatives are the only parties authorized to sign CDAs on behalf of UVM/UVM Medical Center.  Please be sure that no faculty or staff member sign an agreement such as these unless specifically instructed to do so by OCTR or SPA.