thb-researcher-support-contracts

Research Contracts and Clinical Trial Agreements

The Research Administration Contracts Team enjoys supporting a thriving community of researchers whose ideas and discoveries advance our local community and society at large. Our team drafts, negotiates, and finalizes all industry-sponsored, government and not-for-profit contracts and agreements to facilitate research at Hamilton Health Sciences. We work to protect the interests of both the researcher and the hospital, and to ensure that agreements comply with Hamilton Health Sciences’ policies and procedures as well as the regulations and guidelines that govern clinical research. All research contracts involving HHS must be reviewed by a Contract Specialist and must be executed by a designated signing authority. This process is facilitated through the Research Administration Contracts Team. We are happy to meet with researchers at any stage of their career to discuss specific questions, draft customized agreements, or provide input on potential collaborations.

Let’s Get Started

  1. Submit your research agreement to: researchagreements@hhsc.ca
  2. We will perform initial redline and return to sponsor/collaborator within 9 business days.
  3. We will respond to sponsor/collaborator comments within 9 business days of receipt.
  4. We welcome your submissions and are pleased to respond to any questions or feedback you may have. We look forward to working with you to negotiate a fair and reasonable agreement in a timely way.

NEW: BARL Master Agreement

Download the BARL Clinical Trial Questionnaire

  • Non-Disclosure Agreements

    In order to facilitate confidential discussions with collaborators, Hamilton Health Sciences provides the following confidential disclosure agreement template. Simply complete the fillable fields to the best of your ability, and send the agreement to researchagreements@hhsc.ca. We’ll handle returning the agreement to the Sponsor and negotiating any requested changes in a timely fashion. If you have any questions about confidentiality agreements, please read the attached FAQ document, or contact our office at researchagreements@hhsc.ca for more information. NDA FAQ NDA form

  • Data Transfer Agreements

    In order to facilitate the transfer of data with collaborators, Hamilton Health Sciences provides the following data transfer agreement template. Simply complete the fillable fields to the best of your ability, and send the agreement to researchagreements@hhsc.ca. We’ll handle returning the agreement to the collaborator and negotiating any requested changes in a timely fashion. If you have any questions about data transfer agreements, please read the attached FAQ document, or contact our office at researchagreements@hhsc.ca for more information. Data Transfer Agreement Template Data Transfer Agreement FAQs

  • More on CAHO
    CAHO Harmonization of Clinical Study Agreements Initiative

    In an effort to reduce timelines and promote transparency in contract negotiation, our institution has adopted the document developed through an initiative of Council of Academic Hospitals of Ontario (CAHO) and entitled "Statement of Principles to be Considered when Negotiating a Clinical Studies Agreement" which can be accessed on the CAHO website, and is also available for download here. Our institution encourages companies to review and incorporate these principles into their clinical study agreement templates prior to entering into negotiations with us. If any of the items in the principles document are issues of concern, please do not hesitate to contact us to discuss them.

  • More on Indirect Costs Associated with Clinical Trials
    Indirect Costs Associated with Clinical Trials

    Clinical trial agreements with Industry Sponsors are subject to an overhead rate of 30% of the research budget. This charge covers the infrastructure and support costs associated with health research conducted within the academic health science centre. We negotiate this overhead rate with the Sponsor in addition to the research budget to ensure there are sufficient funds to carry out the research after the 30 percent overhead is deducted. Some more complex clinical trials are subject to a charge in excess of 30% applied on a case-by-case basis. This should be discussed directly with your Contract Reviewer. If you are not affiliated with Hamilton Health Sciences or McMaster University and interested in exploring partnership and collaboration opportunities, please contact us.