Clinical Research

Procedure for clinical research

[To physicians planning clinical research] Please be sure to read the following.

  • Proposals for interventional research are examined by the Institutional Review Board (IRB) for Clinical Trials whereas those for non-interventional research are examined by the Institutional Review Board (IRB) for Clinical Research.
  • The protocol of any interventional research project hosted by Kyushu University is put up to CCTR for preliminary examination before it is submitted to one of the aforesaid committees (see below).
  • Other types of clinical research proposals, such as those for genomic research or epidemiological research, are put up for preliminary examination only on request. Therefore, submit the application first (see below).
  • The preliminary examination includes consultations on protocol preparation and implementation of the study and advice (on scientific rationale, biostatistics, and support for preparation of informed consent form, etc.) by members of the 100-member panel.
  • As for the statistical aspects, the number of cases required is to be estimated statistically. Although there are some exceptions in Phase II studies, this is essential for all Phase III studies. If the number of cases required has not been determined statistically, a change in the number of cases may become necessary and such a change may necessitate revising of the entire study design. We therefore recommend that researchers planning Phase II and Phase III studies should consult CCTR at the study planning stage itself.
  • Our support for preparing a study protocol aims at approval (submission to the IRB) within 2 weeks from the notification. Applications are accepted any time, but we may not be able to entertain rush applications submitted made very close to the meeting date of the IRB.

Application for preliminary examination

  • Irrespective of whether you wish to apply for a preliminary examination, please submit a copy of the protocol to CCTR before submitting it to the IRB.
  • Only research projects that involve interventional studies which use a drug, etc. and have a Kyushu University researcher as the principal investigator will be considered for preliminary examination.
  • Questionnaire surveys are not considered for preliminary examination
  • Multicenter studies the protocols of which were prepared outside Kyushu University will not be considered for preliminary examination.
  • The Center provides support to genomic, epidemiological and similar studies only on specific request. Submit such requests in the prescribed format.
    the prescribed format

Flow chart of the preliminary examination

Download from the CCTR website the appropriate application form depending the type of study and prepare the application, study protocol and other documents necessary for the IRB examination.

It is preferable to have definite information on research funding, etc. at this stage.
≫Preparation of application for examination
http://www.med.kyushu-u.ac.jp/crc/research/template.html (in Japanese)

Submission of the application to CCTR, selection of specialists and fixing a suitable date for preliminary examination

Preliminary examination by specialists selected from the 100-member panel (1 hour)
New information added or the contents corrected as needed to make the application a superior research project proposal

Submission to the appropriate IRB for the main examination and approval by the IRB
Note: Please complete the registration with a Clinical Trial Registry before start of the study.

Study initiation, auditing and monitoring

All adverse events that occur must be notified

Support for analysis and preparation of research reports and scientific papers

If you have any questions, please contact CCTR
TEL:092-642-5082 (extension 3771)
E-mail:bynintei@jimu.kyushu-u.ac.jp