About application for examination

We will inform you about the application for examination from the clinical research examination committee of Teikyo University School of Medicine, the examination process, and the format required for the application.

I will mainly explain the flow when applying for the review of new clinical research to the Teikyo University Clinical Research Review Board.
The principal investigator or principal investigator should apply after consulting with ARO (Academic Research Organization) regarding research plans and designs before applying for examination. If you would like to consult with us before applying at the Teikyo Academic Research Center (TARC), please refer to the following and contact us.

Introduction of work at Clinical Research Center (TARC)

Flow of new application

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 on the 2nd floor of the main building).

* ①, ②, ④ attach the file by e-mail, ③ is the original
* Please download the file for self-assessment of conflict of interest from the Ministry of Health, Labor and Welfare website. (Please check 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.

Examination flow chart for new applications

Click here for print data of flow chart

Form required for application / report

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	Before application	New application	Change application	Periodic report	Nonconformity etc.	Illness etc.	cancel	end	Remarks
1	Examination Opinion Business Consignment Application * Emperor Commission (Form 1-1) Emperor Commission (Form 1-2) (off-campus)	〇								Form 1-1 varies depending on the funding source. (File has all formats)
2	Research Implementation Plan * Emperor Commission (Form 2)	〇	〇
3	Consent explanation document * Emperor Commission (Form 3)	〇	〇
4	Consent Form / Consent Withdrawal Form * Emperor Commission (Form 4)	〇	〇
5	Profit Conflict Report Material (Ver.3.1) * Ministry of Health, Labor and Welfare (Forms A-E)	〇			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 multi-institutional joint research, the principal investigator must compile and submit Form E for all medical institutions.
6	Examination Opinion Business Commission Contract * Emperor Commission (Form 5)	〇 (off-campus only)
7	Examination request form ** Emperor Commission (Form 6)		〇	〇	〇	〇	〇	〇	〇
8	New examination request form ** Unified format 2		〇
9	Implementation plan ** Form first		〇							Description sample
10	List of research sharing doctors ** Unified format 1		〇							In the case of multi-institutional joint research, the principal investigator must compile and submit all medical institutions.
11	Procedure manual for dealing with illness etc. ** (Arbitrary style)		〇							Not required when writing in a research plan.
12	Monitoring procedure ** (Arbitrary style)		〇							Not required when writing in a research plan.
13	Audit procedure ** (Arbitrary style)		〇							Not required if not audited or if audited and stated in the research plan.
14	Statistical analysis plan ** (Arbitrary style)		〇							Not required if not created.
15	Documents outlining pharmaceutical products ** (Arbitrary style)		〇							If there is (Example: In the case of approved drugs / medical devices, package inserts, etc.)
16	Case report ** (Arbitrary style)		〇							If there is (example: EDC is a screen copy, etc.)
17	Requirements of the implementing medical institution ** Reference form 2-1 Reference form 2-2		〇
18	resume** Emperor Commission (Form 7-1): For Research (Representative) Responsible Doctors Teikoku Committee (Form 7-2): For research sharing doctors		〇							The research (representative) responsible doctor / research coordinating doctor must submit in the appropriate format. * In the case of multi-institutional joint research, the principal investigator must compile and submit all medical institutions.
19	Education / training attendance certificate ** Various certificate of completion		〇							The research (representative) responsible doctor / research sharing doctor submits one of the following attendance / completion certificates. ・ ICR Web (Basic knowledge of clinical research) ・ APRIN (formerly CITI) ・ Lectures / seminars equivalent to the above 　 * In the case of multi-institutional joint research, the principal investigator must compile and submit all medical institutions.
20	In the case of research involving a company, documents that can confirm the contract status etc. **		〇							Contracts, etc. regarding funding with pharmaceutical manufacturers or their special parties.
21	A document explaining compensation for the health hazards of the subject **		〇							Documents about payments to research participants, if any. (Example: clinical research insurance certificate, etc.)
22	Documents on the procedure for recruiting subjects **		〇							When using advertisements, etc. when recruiting research participants, materials that describe the procedure.
23	Implementation plan matter change notification Form second			〇
24	Change examination request form Unified format 3			〇
25	Implementation plan matters Minor change notification Form 3			〇
26	Minor change notice Unified format 14			〇
27	Periodic report Attachment Form 3				〇
28	Periodic report Unified format 5				〇
29	Serious nonconformity report Unified format 7					〇
30	Disease report Attachment Form 2-1 (Pharmaceuticals) Attachment Form 2-2 (Medical equipment)						〇			Please report to the required address within the reporting deadline. For details, please refer to the "Reports, etc." page.
31	Report on drug diseases, etc. Unified format 8 Medical device illness or defect report Unified format 9 Disease or defect report of products such as regenerative medicine Unified format 10						〇
32	For detailed description of unified form 8-10 Detailed description format						〇
33	Notification of discontinuation of specific clinical research Form 4							〇
34	Cancellation notice Unified format 11							〇
35	Termination notice Attachment Form 1								〇
36	Termination notice Unified format 12								〇

Inquiries

Teikyo University Itabashi Campus Office General Affairs Division School of Medicine Clinical Research Review Committee Secretariat
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8606

TEL: 03-3964-7757（Direct）
E-mail: tkumrb-office@teikyo-u.ac.jp

Weekdays 9:00 to 17:00 (excluding weekends, holidays, founding anniversaries (6/29), year-end and New Year holidays)