Contracting Guide

Study teams are responsible for submitting sponsor and internally required documents though the UMass CCTS TRAcs portal for review and negotiation.

The Office of Clinical Research is providing the following information with an aim to accelerate the contracting process of clinical trial agreements with corporate sponsors of clinical trials, an aim that has been recognized as being universally shared between research universities and corporate sponsors of clinical trials and will foster the rapid advancement of medical technologies and care.

Required Documents

The required sponsor document for a proper OCR submission of a confidentiality disclosure agreement is:

• • • Editable Agreement (or Work Order, if applicable)

The required sponsor documents for a proper OCR submission for an industry sponsored clinical trial with a drug or diagnostic are:

• • • Editable Agreement (or Work Order, if applicable)
    • Budget
    • Schedule of Events (if not clearly outlined in the protocol)
    • Final Protocol
    • Informed Consent

Contracting Party    

• UMass Chan Medical School is the Worcester campus of University of Massachusetts (“UMass”), a public institution of higher education of the Commonwealth of Massachusetts.  UMass Memorial Health (“UMMH”) is the clinical partner of UMass Chan.  Through agreement between UMass Chan and UMMH, UMass Chan utilizes the facility and resource services of UMMH to conduct aspects of corporate sponsored clinical research.  In any corporate sponsored clinical trial agreement with a corporate sponsor that provides for the conductance of such clinical research (“CTA”), UMass, represented through UMass Chan, not UMMH, is the legal party to the CTA.
  
  
• Consistent with the spirit underlying personal liability limitations afforded to employees of the Commonwealth of Massachusetts that are acting within the scope of their employment, UMass Chan will not allow its principal investigators that conduct clinical research to sign a CTA as a legal party to the CTA.

Governing Law and Jurisdiction        

• Given its public nature, UMass’ ability to deploy funds to resolve and litigate legal disputes that may arise from the CTA is subject to various constraints.  Accordingly, UMass Chan requests that the governing law and jurisdiction provisions of the CTA be restricted to that of the law and jurisdiction of the Commonwealth of Massachusetts.  However, if not reasonably practicable to the corporate sponsor to accept those provisions, UMass Chan can agree to remain silent on this issue in the CTA. 

Indemnification       

• Given its public nature, UMass does not have authority to indemnify parties with which its contracts pursuant to the laws of the Commonwealth of Massachusetts.  Accordingly, UMass Chan cannot accept any language in a CTA that would require UMass to do so. 

Subject Injury

• In alignment with UMass Chan’s positions on protections that should be afforded to clinical trial participants of corporate sponsored clinical trials involving investigational drugs or devices, UMass Chan requires the CTA to obligate the corporate sponsor to be responsible for costs associated with injuries that the clinical trial participants might incur as a result of their participation in the clinical trial. Subject Injury Coverage Statement  

Publication

• As UMass is a public institution of higher education and in accordance with UMass’ tripartite mission of education, research and public service, UMass Chan requires language in the CTA which affirms the right of UMass Chan to meaningfully publish the results of the clinical trial, such right being conditioned only upon reasonable delays which allow the corporate sponsor to secure certain rights that may be embodied in the results. 

Reporting of Clinical Data and Findings

In harmonization with UMass Chan’s position on affording paramount protection of human subjects that participate in clinical trials and the standards needed to maintain its accreditation with the Association for the Accreditation of Human Research Protections Program, Inc. (“AAHRPP”), UMass Chan requires language in the CTA which obligates the corporate sponsor to provide UMass Chan with: 1) any data and safety monitoring reports relating to the clinical trial; and 2) any other findings or results that may impact the safety or welfare of the human subjects for the duration, and for at least two (2) years after the completion, of the clinical trial.  For more information on AAHRPP accreditation standards, see www.aahrpp.org.            

Use of the Accelerated Clinical Trial Agreement (ACTA)

UMass Chan Medical School is committed to implementation of tools and methods to expedite clinical trial start-up whenever possible. Therefore, UMass Chan has committed to participate in the Clinical and Translational Science (CTSA) ACTA initiative. In brief, results of the initiative, which included contributions from academic organizations that conduct clinical research and corporate sponsors of clinical research, created a clinical trial agreement template known as the ACTA.  The ACTA contains terms that concisely address the concerns of both the academic and industrial organizations that are customarily associated with corporate sponsored research.  Corporate sponsors desiring to use the ACTA to sponsor a clinical trial with UMass Chan should contact our office at clinicalresearch@umassmed.edu. For information about the CTSA ACTA Initiative, and to access a copy of the ACTA, please go to: https://www.ara4us.org/