24. September 2021

Investigator Initiated Study Agreement

Filed under: Allgemein — @ 09:19

Clinical trials initiated by clinicians can play a key role in answering important medical and scientific questions about rock products and associated therapeutic areas. Such clinical trials can help improve the understanding of Roche`s products and their appropriate use, in order to improve patient care and develop new ideas for further disease research aimed at improving patient treatment. Roche may support studies on the supply of medicines, financing, materials and/or information initiated by auditors, to the extent permitted by local laws and regulations, provided that they correspond to the areas of strategic interest defined by the company. All applications for funding are reviewed to ensure that they do not exceed the local market value. Applications for aid for expenses not related to the conduct of the study are strictly prohibited. Investigator Initiated Studies (IIS) are clinical trials initiated and managed by researchers from a non-pharmaceutical company, such as individual researchers, institutions, collaborative study groups or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the study sponsor for the conduct and management of the study, in accordance with all applicable laws and regulations. Roche requires that the following documents be available before assistance can be initiated: the applicant is informed of the result and if Roche is interested in submitting the concept, the examination physician is contacted and asked to provide further details and a definitive protocol on the IIS in order to be considered for full authorisation. Any new treatment is usually tested in three phases of clinical trials before supervisors consider it safe and effective. Researchers are invited to submit their conceptual proposal through the IIS Submission Portal. Concept submission will be reviewed jointly by Roche`s Review Committee based on scientific findings and compliance with the company`s research and development plans.

Download the „IIS Requester User Guide“ here, which provides step-by-step instructions for registering and filing an IIS proposal. . . .

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