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The Clinical Research Support Center is responsible for supporting clinical trials and clinical studies. It comprises several units and offices with the following diverse functions:
Central Coordinating Unit co-ordinates clinical trials and acts as a data center.
The Central Coordinating Unit, in association with other departments, conducts various clinical trials, including nationwide multicenter, single-facility, or investigator-initiated clinical trials. Our services are diverse, for example, we provide advice regarding development strategy and protocol writing by experienced staff with R & D expertise in pharmaceuticals, data management using the electronic data capture (EDC) system, central and on-site monitoring, and statistical analysis by biostatisticians. We enhance the credibility of high-quality clinical data and data analysis based on our experience of managing more than 70 projects.
To cope with the diversification of clinical trials and clinical studies, experienced CRCs prepare to present the trial before the IRB and communicate closely with clients, support subjects, and investigators to ensure smooth implementation of the trial. Our management of test drugs or information is strict enough for global trials or complicated protocols. We also handle serious adverse event (SAE) reports. Collaboration and information sharing with the Central Coordinating Unit and other departments of T-CReDO makes our support more practical.
Regional Network Office maintains a network of regional medical institutions for better case accumulation.
Networking among medical institutes is essential for development of pharmaceuticals and medical devices. Regional networks, such as the Clinical Trial & Research Network IBARAKI, which has core hospitals in the area, and the University Hospitals Alliance, make trials effective and enhance the quality of clinical research by information sharing. We handle feasibility studies, central IRB operations, and progress management as a whole. We also reach out to citizens to encourage them to participate in the clinical trials and research.
Consultation Office provides support for the planning of clinical studies.
We support researchers in the planning of their clinical research under the Clinical Trials Act or Ethical Guidelines for Medical and Health Research Involving Human Subjects. We aim to clarify their clinical questions, hypotheses, and PICO questions. We advise researchers regarding a variety of subjects, including research design, end-point, optimal sample size, etc. We also collaborate with other units of T-CReDO considering exit strategies with respect to the quality of research and the applicable regulatory requirements.
Administration Office manages the IRB and the Ethics Committee
As the Secretariat of the Institutional Review Board and the Clinical Research Ethics Review Committee, the Administration Office is responsible for organizing work and research ethics workshops, in addition to managing the general affairs of other departments. We perform collective duties and work hard to manage the organization. During clinical trials, we consistently perform administrative procedures including feasibility studies and contract. With respect to clinical research, we conduct ethical review procedures and store management of reports. We respond flexibly to requests on the trial from the sponsor and researchers, coordinate with each department efficiently, and support the operation of clinical trial.
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Phone +81-29-853-3914
Mail t-credo.adm[@]un.tsukuba.ac.jp
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Clinical Trial and Research Network IBARAKI(Japanese)
University Hospital Clnical Trial Alliance