Application for the New Trials

Application / Contract Procedure,　Outline

First contact to the trial office 
Trial office person in charge:
e-mail: ompu_chiken@ompu.ac.jp ,  Phone: 072-683-1221

Meeting at site with the principal investigator prior to the first meeting with the trial office

First meeting with the trial office, examine the site-eligibility for the study, at site (approx.1hour)

Reach the agreement for conducting the study
Make and sign the memorandum for the expense of application-review.
 (You are required to cover the expense of application-review even when we do not reach the conclusion of the final contract of the study. You are required to prepare the memorandum draft. )

Fix the applying IRB date

Fix the Clinical Research Coordinator in charge, name and contact e-mail address will be given by the office
You are able to have contact with the assigned CRC afterwards, who will work for coordinating internal hospital affairs with you.

Meeting / Hearing with CRCs, prior to the IRB discussion (approx.1 hour)
 Explain the CRCs in charge detailed information of the study. Questions should be resolved prior to other following steps.

Meeting / Hearing with the pharmacy department (approx.1hour)

IRB application / review

Conclusion of the contract

Hold the kick-off meeting for the medical staff members who work on the study at site
Facility information is registered with SIP
 

Forms required
Application Procedure Details (only in Japanese)