Terumo Medical Corporation (TMC) is committed to improving patient care through support of Investigator Initiated Sponsored Research (IISR) which may advance scientific knowledge related to TMC technologies. TMC is currently accepting proposals through our online process from clinical investigators interested in conducting their own research.
As opposed to a Terumo-sponsored study, an IISR requires that an investigator and/or their institution fulfill the obligations and responsibilities of both the sponsor and investigator throughout 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, development and authoring of the study protocol, development of any informed consent documents, acquisition and maintenance of IRB approvals, management of study-related documentation, collection of study data and analysis, regulatory reporting, data publication, and any obligations as described in 21 CFR 812 and ISO 14155.
You may contact the clinical affairs department at IISRQuestions@terumomedical.com should you fail to receive an email confirmation or have additional questions.