thb-researcher-support-contracts

Clinical Research Agreements and Contracts

The Research Administration Contracts Team enjoys supporting a thriving community of researchers whose ideas and discoveries advance our local community and society at large by facilitating the contract review and finalization process. Our team drafts, negotiates, and executes all industry-sponsored, government and not-for-profit contracts and agreements to facilitate clinical 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 clinical research agreements and contracts involving HHS must be reviewed by a member of the contracts team and must be executed by a designated institutional signing authority. 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.

Common types of agreements reviewed/drafted include: Data Transfer Agreements (DTAs), Non disclosure/confidential disclosure agreements (NDAs/CDAs), Material Transfer Agreements (MTAs), Clinical Trials Agreements (CTAs) and Amendments.

Let’s Get Started

Please submit your research agreement to researchagreements@hhsc.ca . The agreement will be assigned a reviewer and an initial redline will be returned to the sponsor/collaborator within 9 business days. When submitting your agreement, please do not forget to include:

  1. The name and contact information of the person responsible for review and negotiation of the agreement at the sponsor/collaborator
  2. Any concerns or questions you may have around publication, intellectual property, liability or the budget
  3. Any timelines you are working within (eg: upcoming SIVs, patient enrollment goals etc.)
  4. If you are submitting on behalf of an investigator, include the investigator’s name in the submission

We welcome your submissions and are happy to answer any questions or respond to any feedback you may have. We look forward to working with you!

We are listed under Research Agreements and Contracts, please contact us should you need additional information.

  • 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

    A New Overhead Allocation Agreement for Clinical Trials

    HHS, McMaster University and St. Joseph’s Healthcare Hamilton have entered into an overhead allocation agreement specific to all industry sponsored clinical trials.  While the overhead rate remains the same, at 30 percent of the overall research budget, a new overhead allocation is detailed in the attached document.

    Please note there are two formulas for calculating overhead. One formula reflects overhead distribution for industry sponsored clinical trials performed as part of an Institute (Escarpment Cancer Research Institute, Population Health Research Institute, or Thrombosis and Atherosclerosis Research Institute) and the second formula applies to industry sponsored clinical trials performed by all other Investigators.  Details can be found in the attached pdf document,

    New Overhead Allocation for Industry Sponsored Trials