Research Support Structure

Auditing and monitoring

Auditing and monitoring

Clinical studies leading to the development of treatments must be undertaken properly to deliver the best possible medical care to patients.
Numerous clinical studies are ongoing at the Kyushu University Hospital. These include not only sponsor-initiated clinical studies but also investigator-initiated clinical studies and those on advanced medical treatments. CCTR provides various types of support for planning, management, and implementation of clinical studies.

Against the backdrop of the increasing importance of quality control of clinical studies, CCTR has set up a Monitoring Unit in April 2013.

Monitoring is a quality control activity aimed at protecting human rights, safety and welfare of the study subjects and objectively ensuring the reliability of clinical study data.
In monitoring, the implementation, recording and reporting of the clinical study in compliance with GCP and other applicable laws and regulations, standard operating procedure (SOP), the study protocol, etc. are surveyed and guaranteed, to verify that the data generated is accurate and complete.

CCTR

CCTR believes that the role of monitoring units set up in academic institutions is to ensure that in clinical studies other than sponsor-initiated ones the research is ethical, free from conflict of interest and protects the human rights and safety of the subjects, and that the study is reliable, by maintaining third party quality while in close proximity of the investigators. We feel that an important job of the monitor is to incorporate methods of testing and verifying data from the planning stage itself of the study and to prepare a framework for study implementation that does not permit easy deviation from various regulations and the protocol and are currently preparing such frameworks.

Our endeavor is to provide support, while working closely with all personnel involved in actual implementation of clinical studies, to facilitate high quality implementation of clinical studies for the development of next generation medical treatments.

Get in touch with the following contact if you wish to utilize our services.

Contact
TEL: 092-642-5080 FAX: 092-642-5124

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