Department of Clinical Research Facilitation

Clinical researches play a crucial role for the development of new medicine and optimization of current medicine. Indeed, no matter how good ideas are born in the clinic, they do not lead to the therapeutic improvements, unless they are substantiated by the clinical researches. Particularly, researches with interventions are the human projects underpinned by the dedication of patients, the prerequisite of which is human right protection, and the results of which should be shared by all people. Also, because the results are directly reflected in medicine, clinical researches must not be harmful both to the current and future patients, which are ensured by the scientific validity and data credibility. Inversely, unreliable or fake findings will mislead people, posing serious threats to the public welfare. Then, each clinical research must be implemented through scientifically and ethically righteous methodologies, requiring interdisciplinary approaches in accordance with the principle of clinical science. Thus, we are dedicated to the cultivation of scientific principles underlying the processes, as well as to the facilitation of respective clinical researches.

This unit is involved in the administrative management of specific clinical trial administration committee, which is an important part of the operation of the Clinical Research Core Hospital, and conducts research management activities as a medical institution, while working with related departments of clinical research to improve systems within the university and hospital.

While organizing clinical research promotion seminars, training sessions for investigators and on-the-job training, we are working with mentor doctors recruited from the hospital and other doctors in this unit to promote individual research such as start-up packages. We will continue to devise ways to provide everyone with the knowledge and energy to advance clinical research.

Our unit provides consultation on clinical research to patients and medical professionals both inside and outside Kyoto university.
For university researchers, our unit serves as a navigator and provides access to research support from specialized departments within and outside of iACT. In addition, our unit manages the safety of clinical research and provides consultation services to patients and medical professionals regarding compensation for clinical research.

This department manages clinical research teams through supporting principal investigators. The study managers are all highly experienced and manage clinical research unique to Kyoto University, such as investigator-initiated clinical trials and clinical research on regenerative medicine. The support department will be further strengthened by the addition of a physician as a study manager.

The Clinical Research Coordination Unit coordinates clinical trial/research to ensure that it is conducted safely and appropriately, focusing on supporting patients and assisting physicians. Our unit also takes in charge of the site management, the Institutional Review Board office, and investigational drugs management.

The unit performs the following tasks.

1. Establishment of a mechanism to identify and introduce seeds for promoting international collaborative research in partnership with overseas companies and institutions.
2. Establishment of a system to jointly promote the international development of seeds after evaluating the organization, activities, and achievements of overseas AROs.
3. Support for international development of individual seeds using the above infrastructure.
4. Attract clinical trials to Kyoto University Hospital.
5. Intermediation between Kyoto University researchers and overseas researchers.

Our audit unit objectively evaluates whether clinical research is being conducted appropriately based on its compliance with regulatory requirements, Standard Operating Procedure (SOP), and research protocols. We also conduct individual audits of clinical research upon request from principal investigators.