The Clinical Trials and Business Development unit within the Department of Evaluation and Research Agreement (DERS) provides in-house contract review and negotiation services.
Updated December 21, 2022
It is a responsibility of the principal investigator to ensure that the draft contract has been obtained from the sponsor and submitted to DERS for review. Although it is not required that ethics approval has been received prior to contract negotiation, it is expected that the Fraser Health principal investigator has submitted an initial ethics application beforehand.
What is a research agreement?
Research agreement, also referred to as research contract or Clinical Trials Agreement (CTA), is a legally binding agreement that dictates the terms and conditions that govern the collaboration of research. Terms and condition may include but are not limited to deliverables, deadlines, finance, intellectual property and publication.
Who are the parties to the research agreement?
- Sponsors (funder) and/or coordinating institution (if Fraser Health is a secondary site)
- Principal investigator and Fraser Health principal investigator (if different from principal investigator)
- Administrator (if principal investigator has delegated administrative tasks to an external organization)
- Fraser Health Authority (institution)
Please note that a privileged physician is not a Fraser Health Authority employee and is a separate entity.
Do I need a research agreement?
All industry sponsored clinical trials conducted within Fraser Health Authority require a contract.
Academic studies will require a contract unless the following criteria has been met:
- Study is unfunded
- Study only requires de-identified data (no patient identifiers)
Some institutions may require an agreement for non-funded studies. In those cases, the agreement will be reviewed on case-by-case basis. Please contact research.contracts@fraserhealth.ca for more information.
What are the types of research agreement?
Types of agreements include, but are not limited to:
- Clinical trial agreement
- Data transfer agreement
- Data disclosure agreement
- Material transfer agreement
- Service agreement
- Research collaboration agreement
What do I need to do before submitting a draft contract to DERS?
Please ensure that you:
- submitted initial ethics application
- requested and obtained the draft contract from the sponsor
- carefully review intellectual property and publication clauses on the draft contract. The contract will be negotiated in accordance with Fraser Health intellectual property policy unless otherwise stated in the contract intake event form
- notify the sponsor of the requirements for insurance and institutional overhead
How do I submit an agreement for review?
Complete and submit the Contracts intake event form on ROMEO with a draft contract attached for review. Incomplete intake event forms will be submitted back to the researcher for completion and will not be completed without a draft contract. Please communicate any prior arrangements made between the principal investigator and sponsor pertaining to research on the Contracts intake event form.
When can I expect to hear from DERS after contract submission?
The research contracts coordinator will review and return the contract draft for sponsor’s review via email. Contacts listed on the Contract intake form will be included in the correspondence.
The research contracts coordinator aims to complete the initial review within two weeks of contract intake. Please ensure that the Contract intake form is completed. The research contracts coordinator may get in touch with you directly for more information.
What is my next step after contract submission?
Please negotiate the budget with the sponsor directly and ensure that institutional overhead has been applied to all applicable direct fees. For more information on budgeting, please find the page here.
What do I do if there is a contract amendment?
Any amendment to the contract requires an approval and signature from Fraser Health Authority if Fraser Health Authority is a party to the initial agreement. Please submit the Contracts amendment event form on ROMEO.
Who do I contact for additional questions?
For any research contracts inquiries, please email research.contracts@fraserhealth.ca.