We will guide you through the process of applying for and submitting to the Teikyo University School of Medicine Clinical Research Review Committee, as well as the necessary application forms.
This document primarily explains the process for applying for review of a new clinical research project to the Teikyo University Clinical Research Review Committee. The project manager or principal investigator should consult with an ARO (Academic Research Organization) or similar organization regarding the research plan and design before submitting the application for review. If you wish to receive consultation before submitting your application at Teikyo Academic Research Center please refer to the information below and contact us.
Please confirm the conflict of interest before applying. The procedure and usage format are the same for applications to the University Committee and applications to the Off-Campus Committee.
Please fill out the form below and submit the following four items to the School of Medicine Clinical Research Review Committee Secretariat (located in Itabashi Campus Office 2nd floor of the Main University Building).
④ Conflict of Interest Self-Declaration Form File (Forms DE should be left blank)
* ①, ②, ④ attach the file by e-mail, ③ is the original
* Please download the conflict of interest declaration form and other related files from the Ministry of Health, Labour and Welfare website. (Please check for the latest format.)
Notification of application to the Accredited Clinical Research Review Board
When applying for a new application, the examination will be conducted according to the following flow.
Click the format name to open the word format. Please fill in the required items and submit. The forms of various application forms may be updated. Always download and use the latest version.
NO.
document * Documents required for pre-application confirmation in the new application flow ** Examination documents at the time of examination application in the new application flow
Conflict of Interest Reporting Document (Ver. 3.1)*
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〇 (if necessary)
The file contains forms A to E, but only forms A and E need to be submitted to the Accredited Clinical Research Review Board.
*In the case of a multi-center collaborative study, the overall administrator should compile and submit Form E for all participating medical institutions.
In the case of a multi-center collaborative study, the overall administrator is responsible for compiling and submitting data from all participating medical institutions.
11
Procedure manual for dealing with illness etc. ** (Arbitrary style)
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Not required when writing in a research plan.
12
Monitoring procedure ** (Arbitrary style)
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Not required when writing in a research plan.
13
Audit procedure ** (Arbitrary style)
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Not required if not audited or if audited and stated in the research plan.
The overall administrator, principal investigator, and co-investigators should submit their respective forms.
*In the case of a multi-center collaborative study, the overall administrator should compile and submit data from all participating medical institutions.
19
Education / training attendance certificate ** Various certificate of completion
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The overall administrator, principal investigator, or co-investigator must submit one of the following certificates of completion.
・ ICR Web (Basic knowledge of clinical research)
・APRIN
・ Lectures / seminars equivalent to the above
*In the case of a multi-center collaborative study, the overall administrator should compile and submit data from all participating medical institutions.
20
In the case of research involving a company, documents that can confirm the contract status etc. **
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Contracts, etc. regarding funding with pharmaceutical manufacturers or their special parties.
21
A document explaining compensation for the health hazards of the subject **
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Documents about payments to research participants, if any.
(Example: clinical research insurance certificate, etc.)
22
Documents on the procedure for recruiting subjects **
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When using advertisements, etc. when recruiting research participants, materials that describe the procedure.
23
Notification of Changes to Implementation Plan Items
