As opposed to a Terumo-sponsored study, an IIS requires that an investigator and/or their institution fulfill the obligations and responsibilities of both the sponsor and investigator throughout the conduct of the study.

While TMC may provide financial support and/or devices for the study according to a study agreement, the investigator is the study sponsor.  As such, the investigator is solely responsible for overseeing the conduct of the study from initial concept through completion.

Duties that must be independently performed include: securing adequate resources to conduct the study, developing and authoring the study protocol, developing any informed consent documents, acquiring and maintaining IRB approvals, managing study-related documentation, collecting study data and analysis, regulatory reporting, data publication, and complying with any obligations as described in 21 CFR 812, ISO 14155, International Council for Harmonization (ICH),  and Good Clinical Practice (GCP).

It is important to note that any submission involving a significant risk device or study population that is not consistent with the current device labeling indication(s) (i.e., “off-label” use of marketed devices) will require an Investigational Device Exemption application (IDE) to the U.S. Food and Drug Administration (FDA) or local regulatory equivalent and approval by the agency prior to initiation of the study.  Please visit www.fda.gov for further information.

In addition, the sponsor-investigator must comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (www.icmje.org), established by the International Committee of Medical Journal Editors (ICMJE).  TMC recommends that you and your institution add your study to the FDA’s ClinicalTrials database (www.clinicaltrials.gov) or similar trial registry website in your country.  Please note this may also be a prerequisite for publishing in select journals (e.g., the ICMJE).

For additional information about your responsibilities as a sponsor, please visit the following public websites:
 

Our mission at Terumo Medical Corporation (TMC) is to support investigator-initiated studies to advance medical and scientific knowledge about Terumo products that may generate promising interventions.  As such, the types of research 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 a commercial interest

In order to expedite the review and approval process, your concept submission on the TMS portal should include basic study and investigator-sponsor information sufficient to assess the study concept. If the concept is approved by TMC, the investigator-sponsor will be notified to complete the application including but not limited to the full study protocol and detailed budget. Once all documentation is submitted, TMC will review the full application and the investigator-sponsor will be notified of the decision.

* 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 that include but are not limited to:

· Studies without a protocol or synopsis and budget
· Studies that do not plan to obtain IRB/EC approval
· Travel or registration fees for conferences, excluding cases where study results are being presented for the purpose of disseminating findings, which should be included in the research study proposal and as a line-item in the budget.
· 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.