An Investigator Sponsored Trial (IST) involves the investigation of GE HealthCare Pharmaceutical Diagnostics Investigational products or licenced products in scientifically valid clinical studies initiated, designed, and conducted by Principal Investigators (PIs) who function as both Sponsor and Investigator.
GE HealthCare Pharmaceutical Diagnostics does not solicit IST proposals, dictate design of an IST, write the IST Protocol, or bear responsibility for the execution of an IST – the IST review and approval process represents a mechanism for GE HealthCare Pharmaceutical Diagnostics to make imaging compounds available to members of the scientific and medical research community who are interested in utilizing our investigational and licenced product to pursue specific research questions.
The decision to facilitate the external research efforts with GE HealthCare Pharmaceutical Diagnostics products depends on favourable scientific and technical reviews, availability of the product and/or financial support, and agreement that the study is consistent with the GE HealthCare Pharmaceutical Diagnostics development and medical strategies for the product.
Oversight for IST proposals is provided by the GE HealthCare Pharmaceutical Diagnostics Investigator Sponsored Trials Committee (ISTC) in order to ensure that exchanges of information, support decisions, and follow-up activities between GE HealthCare and IST investigators (and their institutions) are conducted in a compliant and timely manner. Accordingly, the role of the ISTC is to review and, if appropriate, approve external requests for support of Investigator Sponsored Trials (IST).
The actions of the ISTC are under the direction of the ISTC Chairperson. At no time shall any support offered by the ISTC be provided to an investigator and/or research institution in exchange for a commitment to prescribe, supply, administer, recommend, purchase or sell any GE HealthCare Pharmaceutical Diagnostics products in the future, or to grant GE HealthCare Pharmaceutical Diagnostics products formulary status. Product provided by GE HealthCare Pharmaceutical Diagnostics and any monetary support to investigators or their institutions will be reasonable and fair market value based on the work performed by the investigator and his/her staff and not on any other considerations.
When conducting an IST with GE HealthCare products, the PI will have responsibilities towards GE HealthCare Pharmaceutical Diagnostics according to local/national and Good Clinical Practice (GCP) requirements.
Just a moment, the page is loading...