Information for each Department

Control Division

Center for Clinical Research

Director Yutaka Shimomura Director
Yutaka Shimomura

Service Contents

Center for Clinical Research puts great effort into executing clinical trial in accordance with a public assurance that rights, safety and well-being of trial subjects are protected. Our staffs who have an academic or industry-based experience provide comprehensive support and insight for investigator and industry sponsors.

Team for Investigator Initiated Trials

We communicate investigators who intend to develop study concept or protocol, and support them for preparing document submission to the Institutional Review Board Committee in Yamaguchi University Hospital. Our competency ensures a wide view for study planning and clinical operation, e.g. study planning / data management / quality management / document workflow.

Team for Registration aimed Clinical Trials (CHIKEN)

We communicate both industries and investigators who intend to conduct clinical trials in accordance with Pharmaceutical Affairs Law related rules and regulations. We enhance clinical trials in which the Clinical Research Coordinators (CRCs) are a vital competent. CRC takes a key role between the investigator, subject, IRB and clinical sponsor through the collaboration with administrative staffs. Our competency ensures a comprehensive skills to coordinate the daily activities related to clinical trial, e.g. patient enrollment support / informed & consent procedure / Care Report Form completion support / managing investigational products.

Team for Regenerative Medicine

Regenerative medicine is a new interdisciplinary field aiming to provide safe and reliable ways to treat many diseases. To promote the development of regenerative medicine, it is important to take a balance of expedited provision of innovative therapies and appropriate steps to ensure safety and efficacy. We support investigators who intend to carry out regenerative medicine (non-commercial clinical trials, daily practice) like the Investigator Initiated Trials.

Administrative Office for the Institutional Committees

Bureaucratic works to assist following two committees,

1) The Institutional Review Board under the following rules and guidelines,
 ・GCP in accordance with the Pharmaceutical Affairs Low
 ・Ethical Guidelines for Medical and Health Research Involving Human Subjects
 ・Ethical Guidelines for Human Genome and Genetic Sequencing Research
 And others depend on research proposal.

2) The Certified Special Committee for Regenerative Medicine, in Yamaguchi University .which is approved by the Minister of Health, Labour and Welfare through certain formalities and is capable to review even the high risk category classified by the regenerative medicines depending on the potential risk to human health, under the Act on the Safety of Regenerative Medicine.

3)The Certified Review Board reviews clinical research under the “Clinacl Research Act”, which is corresponding to either of followings: 1) clinical research that receives Grants from a pharmaceutical company or a medical device company or 2) clinical research using drug or medical device not approved under Pharmaceutical and Medical Device Act (PMD Act) or involving off-label use.

List of each Department
Clinical Division
Clinical Facility
Control Division
Pharmacy Department
Division of Nursing

Yamaguchi University Japan Council for Quality Health Care

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