IISR PROPOSAL REQUIREMENTS
Our mission at Terumo Medical Corporation (TMC) is to support Investigator Initiated Sponsored Research studies to advance medical and scientific knowledge about Terumo products which may generate promising interventions. As such, the types of research that are eligible for support include:
- Clinical studies of approved and unapproved uses, including approved or unapproved TMC devices
- Observational studies where the primary focus is the scientific understanding of a disease
- Other types of independent research on disease states where TMC may not have commercial interest
In order to expedite the review and approval process, your submission should provide sufficient information to make a decision regarding funding of your study. Proposals may be submitted by using TMC’s IISR portal to electronically submit your proposal. If TMC is interested in supporting the proposal, the Investigator-Sponsor will be asked to submit a full proposal including but not limited to a full protocol, detailed budget, and informed consent.
* TMC is dedicated to complying with legal requirements for full transparency and due diligence around all financial interactions with healthcare professionals, their institutions, and related organizations. Prior to budget submission, please ensure any study-related expenses are appropriately identified, itemized, and commensurate with fair market value (FMV).
Please note that TMC will not fund the following activities or study proposals:
- Studies without a protocol or synopsis and budget
- Studies that do not plan to obtain IRB/EC approval
- Travel or registration fees to conferences for presentations
- Support for ongoing clinical programs already a part of your organization’s routine operations
- Purchase of capital equipment unrelated to the study or that would generate revenue
- Any study expense not adequately documented or non-commensurate with fair market value
- Construction of new facilities within or supporting your organization
- Hiring of staff or any overhead expenses not dedicated to the study
- To any individual or institution/entity identified on, associated with, or any organization or known individual identified on the Specially Designated National List of the U.S. Treasury Dept., the Department of Health and Human Services Office of Inspector General’s Exclusion Database, the FDA’s debarment list, or the GSA list of debarred persons.