Mandatory Contract and Grant Reviews

All contracts and grant applications for awards of external funding must be reviewed and approved centrally by UVM or UVM Medical Center.  For applications and contracts which are federally funded, investigator-initiated, or laboratory based research, this process is managed by Sponsored Project Administration (SPA) and processed through UVM.  For clinical research funded by an industry sponsor, this process is managed by the Office of Clinical Trials Research and processed through UVM Medical Center.

This serves several purposes:

• Protection of the rights of the investigator to own, publish, and present research data, where desired
• Protection of the investigator, research staff, institution, and all involved in our research enterprise in the event of any legal action
• Assurance of the most favorable contract terms for the investigator, including but not limited to financial and payment terms

UVMMC Processing: All contracts must be reviewed by OCTR prior to signature.  Forward a draft or final contract to the attention of Mark Tomase, Regulatory Specialist for OCTR.  After the review, your contract will be signed by the authorized official of UVMMC and returned to the sponsor.

Learn more about using our new Clinical Trials Management System OnCore Clinical Trials Management System

Physicians and clinicians performing diagnosis, prognosis, or treatment at UVM Medical Center are credentialed via standardized protocols by the UVM Medical Center Medical Staff Office (MSO). Therefore, UVM Researcher Credentialing is NOT required if the researcher is already credentialed through the MSO. UVM employees involved in clinical research but not credentialed through the MSO will be credentialed by the Office of Clinical Trials Research (OCTR) and onboarded via the UVM Health Network (UVMHN) collaborating clinical department. The OCTR Director, in coordination with the UVMHN sponsoring director, will approve credentialing and direct employees to Human Resources for badge renewal or photos. The UVMHN sponsor is responsible for ongoing oversight of research employees in their area.

It is mandatory for University of Vermont (UVM) employees involved in clinical research activities at The University of Vermont Health Network to complete and submit the credentialing documents to the Office of Clinical Trials Research (OCTR).  This includes working on projects involving direct patient interaction, retrieving blood, tissue, or health record data review.

OCTR is responsible for collecting the required research credentialing files for UVM clinical research faculty and staff. Please refer to the OCTR SharePoint UVM Researcher Credentialing page for further information.   

To ensure we are diligent in maintaining and keeping our files current, the UVMMC research badge expires annually on June 30th.

If you need additional assistance please contact the Office of Clinical Trials Research at 656-8990 or clinicaltrials@med.uvm.edu.

Budget Support

This service is to develop a financial framework that supports the work of the organization and maximizes support to the clinical investigators.  The office will provide financial analysis of the research protocol and contract pricing information, and assist in the development of draft budgets. 

If you are interested in more information, please contact us at: clinicaltrials@uvm.edu 

This service provides investigators interested in participating in clinical trials research flexible trained staff to support their research activities.  The office will provide total coordination or simply provide the coverage you need.  If you are interested in more information or would like to arrange support for your trial, please contact Kimberly Luebbers.

External Coordinator Training Resources:

Association of Clinical Research Professionals

Drug Information Association (DIA)

Society of Clinical Research Associates, Inc

Organizational Address:

The University of Vermont Medical Center Inc.
111 Colchester Avenue
Burlington, VT 05401

Tax ID No.: 03-0219309

Notices:

All notices should be sent directly to the Principal Investigator.

Institution Signature:

Kimberly Luebbers, MSHS, RN, BSN, OCN®
Assistant Dean for Clinical Research Administration
1 S. Prospect Street, Arnold 3437
Burlington, VT 05401

Or

Claude Deschamps, MD
President and Chief Executive Officer, University of Vermont Medical Group
111 Colchester Ave, Patrick 3
Burlington, VT  05401

Organization Type:

The University of Vermont Medical Center is a private, non-profit 501(c)(3) organization. Its Board of Trustees meet monthly to represent a cross-section of the communities served by the UVM Medical Center including members from each of the four predecessor organizations (Fanny Allen Hospital, Medical Center Hospital of Vermont, University Health Center, and the University of Vermont).

Request for Services Schedule an OCTR Exam Room: To request an OCTR exam room(s) on Arnold 3, 1 South Prospect Street (UHC), complete the OCTR Exam Room Scheduling Form. NOTE: This form is used for new requests as well as canceling or rescheduling existing exam room requests.

Request must be made at least 24 hours in advance. For request made within 24 hours of the visit, please complete the OCTR Exam Room Scheduling Form and email clinicaltrials@med.uvm.edu.

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
mark.tomase@med.uvm.edu

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 email the document, along with the contact information from the originating sponsor, to OCTR at clinicaltrials@med.uvm.edu or your analyst in SPA at spa@uvm.edu , 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 at: mark.tomase@med.uvm.edu 

• 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 at: mark.tomase@med.uvm.edu 

• 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.

Research Subject Registration Requirements at the University of Vermont Health Network

The Principal Investigator (PI) or delegated key personnel of the research team are responsible for establishing and following procedures for research subject registration. The process of research subject registration must comply with federal and state regulation, University of Vermont (UVM) Health Network policy, and Good Clinical Practices (GCP) in research. Proper registration of patients as research subjects is necessary to support safe clinical care and accurate billing of research related services.

This policy applies to all research subjects at UVM Health Network sites that use EPIC. 

This policy does not apply to patients where their study participation only involves online/phone surveys, or in-person interviews/questionnaires.

The reasons we register patients as research subjects in EPIC are:

1.  Patient safety is enhanced because we will be able to identify in EPIC when our patients are enrolled in clinical studies. Having a complete picture of a patient's activities across our institutions enables us to provide the safest, most appropriate care.
2. We enhance our ability to leverage EPIC as a source of information for research endeavors.
3. Centers for Medicare and Medicaid Services require that some (but not all) clinical trials claims have an accompanying National Clinical Trial Registry number.  All research claims must be identified as research – not clinical care.  Billing for research related expenses in any other way is considered fraudulent.  Significant fines have been levied against other major Academic Medical Centers for billing research related charges incorrectly.  Some institutions have been banned from doing future research due to their non-compliance of this federal requirement. Registering our patients as research subjects in EPIC enhances our ability to be in compliance with research billing regulations.

We appreciate your support of this important initiative, and look forward to the opportunities it will provide to improve research activities at the UVM Health Network and the University of Vermont.  The IRB works closely with the IT Research Subcommittee to ensure that all appropriate protections of human research subjects are in place as we better utilize EPIC to support research.

For Research Subject Registration FAQs, Research Subject Registration SOP and EPIC Tip Sheets, please visit the OCTR SharePoint site.

The Research Professionals Network (RPN) was developed in collaboration with Boston University, University of Florida and Medical University of South Carolina, to enhance the quality of clinical research at UVM, UVM Medical Center and the UVM Health Network by supporting the professional development of clinical research faculty and staff.

Major objectives of the RPN are to:

• Provide professional development opportunities for research professionals through trainings, workshops, seminars, discussion groups, and other educational events
• Encourage mentoring and networking amongst research professionals within and outside of the UVM/UVM Medical Center research community
• Support an effective, efficient system to keep network members up to date on changing policies and regulations
• Increase awareness and communication of best practices and innovation to promote participant recruitment, retention, and satisfaction
• Maximize satisfaction and productivity and efficiency of all members of the research team through sharing of resources

Membership in the UVM RPN is open to all UVM, UVM Health Network, and Maine Medical Center and Dartmouth/Dartmouth Health (via NNE-CTR affiliation) research personnel involved in clinical research such as investigators, research managers, research supervisors, clinical research nurse, clinical research coordinators, regulatory coordinators, research pharmacists, data managers/analysts, and research assistants.

CEUs can be used by ACRP and SoCRA Certified staff to maintain certification.
 

Join the UVM Research Professionals Network. More information about RPN Workshops.*RPN workshops are open to all members. Typically, advanced workshops will begin at a level that assumes attendees have some fundamental knowledge about the topic.

Additional information for UVM/UVM Medical Center research professionals can be found on our LCOM SharePoint Research Professionals Network site. Use the left navigation menu on the webpage to find our Research Events Calendar, Research Professionals Network and other research resources.

For questions regarding the UVM Research Professionals Network, please contact the Office of Clinical Trials Research via email at clinicaltrials@med.uvm.edu or call 802-656-8990.

What Is the Definition of a Clinical Trial for Registration Purposes?

Three similar definitions of a "clinical trial" are provided below. If your study meets any one of these definitions, the trial should be registered.

The FDA (Food and Drug Administration) requires registration for "applicable clinical trials" defined as follows:

• For any trials of drugs and biologics: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation.
• For trials of biomedical devices: controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.

The ICMJE (International Committee of Medical Journal Editors) definition of a clinical trial includes:

• Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

The NIH defines a clinical trial as:

• A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)

Visit the OCTR SharePoint ClinicalTrials.gov page for more information

Assistant Dean

Administrative

Research Nurses/Clinical Coordinators

Address:

Office of Clinical Trials Research
UVM Larner College of Medicine
1 South Prospect Street
3437 Arnold Pavilion
Burlington, VT 05401

Email: clinicaltrials@uvm.edu  

Phone: (802) 656-8990
Fax: (802) 656-4074