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Department of Clinical Research Governance

The Department of Clinical Research Governance was established in 2015 to control governance of conducting clinical research, for complying research ethics and ensuring reliability of clinical research which we promote as a university-affiliated hospital committed to providing highly advanced medical services.

Overview

The Department of Clinical Research Governance was established in 2015 to control governance of conducting clinical research, for complying research ethics and ensuring reliability of clinical research which we promote as a university-affiliated hospital committed to providing highly advanced medical services.

To conduct highly-qualified clinical research, we will strengthen the following areas:
1. Compliance with research ethics
2. Ensuring research reliability
3. Proper management and promotion of clinical research

Organization

The Department of Clinical Research Governance is composed of three offices:
1) Office of Research Support
2) Office of Promotion of Fair Clinical Research
3) Office of Clinical Research Quality & Compliance

Activities

1) Office of Research Support
・Drafting of overall strategy for research and development at our hospital
・Functioning as a secretariat for applying to openly inviting large-scale research project proposals related to research and development in our hospital
・Examining strategy for financial self-sufficiency in the hub of clinical research
・Inspecting research activities conducted at our hospital and creating their database
・Collecting information on clinical research from external sources
・Providing administrative support for the Advanced Medicine Development Promotion Management Committee
・Providing administrative support for the Steering Committee on Specified Clinical Research
・Providing support for constructing appropriate framework to conduct clinical research
・Providing support for promotion of medical venture companies

2) Office of Promotion of Fairness in Clinical Research
・Watching research
・Functioning as a consultation desk for research fraud
・Supporting education for fairness in clinical research
・Providing information on training programs

3) Office of Clinical Research Quality & Compliance
・Auditing clinical study/research (including study audit and system audit)
・Providing guidance and advice regarding clinical study/research reliability
・Performing periodic analysis on audit results and reliability of clinical study/research and reporting it to the hospital Director; proposing regarding the construction of framework of our hospital for ensuring the reliability of clinical study/research
・Providing support for compliance inspection (on-site GCP) by regulatory agency; unified management of the results
・Supervising audits conducted by external audit organizations (CRO, NPO)
・Unified management of audit results conducted by other external organizations (such as audit in sponsor initiated clinical trial)
・Following up on corrective/preventive actions based on the results of inspection and audit
・Collecting regulatory information, analyzing problem cases, and providing educational programs, on reliability of clinical study/research
・Functioning as the secretariat of Working Group on Audit in the clinical research hub network

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