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Department of Clinical Research Governance
The Department of Clinical Research Governance was set up in January 2015 with the aim to respond to the various issues surrounding clinical research, and to construct a framework within the University of Tokyo Hospital to promote reliable clinical research.
Overview
The “Department of Clinical Research Governance” was set up independently from the Clinical Research Promotion Center in order to allow for appropriate and agile responses to the various issues surrounding clinical research, prevent research ethics issues and research misconduct, and promote reliable clinical research. By doing so, the University of Tokyo Hospital aims to construct a framework to take initiative in managing and promoting clinical research.
Organization
The Department of Clinical Research Governance is composed of three offices; 1) Office of Strategic Planning and Promotion; 2) Office for Research Integrity and Promotion; and 3) Office of Clinical Quality Assurance & Compliance. These offices mutually cooperate to promote and strengthen the governance function within the hospital.
Activities
Office of Strategic Planning and Promotion
It systematically promotes clinical research by assuming responsibility for general strategy formulation for the development of advanced medicine, inspecting research activities, handling applications for major researches, and promoting cooperation with related parties.
Office for Research Integrity and Promotion
It provides advice to researcher in relation to ethical and scientific reliability of clinical study. In cooperation with the Office for Human Research Studies of the Graduate School of Medicine and Faculty of Medicine, it also educates and disseminates information such as research ethics and code of conduct.
Office of Clinical Quality Assurance & Compliance
It carries out quality assurance operations related to investigator initiated clinical t r ials and clinical s tudies. It per forms audi ts and suggests improvements, provides advices and educates about constructing a framework to ensure reliability.
