Advanced medical care research projects led by researchers of the University
For advanced medical care research projects initiated by researchers of Kyushu University itself, the documents listed below are required to be submitted to CCTR at the time of planning and drafting (preparation stage of protocol). These will be examined for compliance with requirements.
The workflow up to protocol preparation
The investigators must submit the following documents.
- Concept of the research project
Download the template (in Japanese)
Clinical Research Promotion Office, CCTR, Kyushu University Hospital
In-Charge TEL:092-642-6290
E-mail:tr-info@med.kyushu-u.ac.jp
- Framework for implementation of the project
You may consult about the kind of support that you wish to receive from CCTR, such as from units like drug management, data center, CRC, monitoring, auditing, etc.
- Status of, or plans for, funding the project
- Status of negotiations with PMDA and the Ministry of Health, Labor and Welfare (MHLW)
The researchers and CCTR mutually confirm the key points to be discussed in meetings with PMDA and MHLW.
- Status of negotiations with private enterprises
For drug research projects, it must be ascertained whether the drug will be provided by a private firm. The post-study application for drug approval or for approval of additional indications must also be discussed.
After the aforesaid documents are submitted, the CCTR side will provide support for the following items in order to enable the medical care research project to advance.
- Advise on issues up to implementation of the research project
- Support in dealing with PMDA (consultation on pharmaceutical affairs strategies)
- Support in dealing with Health Policy Bureau of MHLW (preliminary consultation on advanced medical care research projects)
Preparations for starting advanced medical care research projects
- The protocol prepared must be submitted to the CCTR before it is submitted to the Advanced Medical Treatment Council.
Submit to
Clinical Research Promotion Office, CCTR, Kyushu University Hospital
In-Charge TEL: 092-642-6290
E-mail:tr-info@med.kyushu-u.ac.jp
- The protocol is examined and the state of preparedness of the setup for conduct of the research is verified in a meeting of TR Promotion Office of CCTR (this corresponds to the preliminary examination).
- The Kyushu University IRB for Clinical Trials is then consulted. The university’s Advanced Medical Treatment Committee provides guidance for coordination with the concerned units (Strategic Planning Section, Pharmacy and CCTR) of the university hospital.
- The protocol is examined by the Advanced Medical Technology Council of MHLW.
- Approval of the Advanced Medical Treatment Council is obtained after approval by the Advanced Medical Technology Council of MHLW
When Kyushu University is participating in the advanced medical care research project as a collaborating institution
When Kyushu University is a collaborating institution in an advanced medical care research project led by some other university, consult CCTR at the time when a department is considering participation or when such participation is decided. The meeting of CCTR’s TR Promotion Office then examines the following aspects.
Preparations for the start of advanced medical care research project
The researchers must submit documents concerning the items listed below.
- Protocol, final version
- Framework for implementation of the project
You may consult about the kind of support that you wish to receive from CCTR, such as from units like drug management, data center, CRC, monitoring, auditing, etc.
- Status of, or plans for, funding the project
CCTR then gives advice about the formal procedures in the hospital and preparing the framework for implementing the research project.
- The application for the advanced medical care research project is then prepared in the Patient Service Division.
- Consultations are held with the Kyushu University IRB for Clinical Trials.
- The Advanced Medical Treatment Committee of Kyushu University then gives guidance on coordination with the concerned units (Strategy Council, Pharmacy and CCTR) of the University Hospital
