Teikyo University School of Medicine Clinical Research Review Committee
This is the page of the Teikyo University School of Medicine Clinical Research Review Committee, established in accordance with the Clinical Research Act.
With the implementation of the Clinical Research Act, this website introduces the necessary procedures and documents for conducting clinical research based on the law, including specific clinical research that is required to comply with the standards of the law.
About the Teikyo University School of Medicine Clinical Research Review Committee
The Teikyo University School of Medicine Clinical Research Review Committee reviews and provides opinions on clinical research as stipulated in the Clinical Research Act (Act No. 16 of 2017).
The Teikyo University School of Medicine Clinical Research Review Committee provides neutral and fair review and opinion work from ethical and scientific perspectives in accordance with the Clinical Research Act enforcement regulations when requested to provide opinions on clinical research implementation plans based on the Clinical Research Act by researchers from the university as well as external researchers.
Examination points (excerpt from Article 9 of the Clinical Research Law Enforcement Regulations)
In accordance with the basic principles of clinical research in Article 9 of the Clinical Research Law Enforcement Regulations, all research requested for examination will be examined fairly based on the following points.
Being a clinical study with social and academic significance
Scientific rationality is ensured according to the characteristics of the field of clinical research.
Weighing the benefits of clinical research and the burden on the subject and other disadvantages
Sufficient explanations have been given to the subject in advance, and consent has been obtained based on the subject's free will.
Necessary and appropriate measures should be taken for those who require special social consideration.
Proper management of personal information used for clinical research
Ensuring the quality and transparency of clinical research
Committee overview
This committee was certified by the Minister of Health, Labor and Welfare on March 13, 2019 as a committee that meets the requirements stipulated in the Enforcement Regulations of the Clinical Research Law.
We will introduce the regulations and various procedures of the Teikyo University School of Medicine Clinical Research Review Committee.
The Teikyo University School of Medicine Clinical Research Review Committee has established and published regulations for the review and opinion work it performs. Additionally, it has established standard operating procedures for measures required for the implementation of review and opinion work under the Clinical Research Act Enforcement Regulations.
Information on the Teikyo University School of Medicine Clinical Research Review Committee meeting dates, application deadlines, review fees, etc.
If you would like to request a review from the Teikyo University School of Medicine Clinical Research Review Committee, please confirm the date of the committee meeting, the deadline for submitting the documents required for application, the fees for the review, etc., and then contact the committee secretariat.
Examination status
Holding schedule (holding schedule and application deadline) As a general rule, a committee meeting is held at least once a month to carry out examination work. The change of the date will be announced on the committee page.
Reception status There is a limit to the number of cases that can be accepted in a month, so please contact the committee secretariat in advance if you wish to be examined.
Acceptance deadline / notes The deadline for accepting the documents required for application is about two months before the scheduled date of the committee meeting. Please submit the required documents by the deadline. Even if the documents are submitted by the deadline, it may not be possible to examine them on the scheduled committee meeting date due to incomplete documents. Please submit the documents with plenty of time.
