Application for the New Trials
Application / Contract Procedure, Outline
First contact to the trial office
Trial office person in charge: A.Onozuka (Pharmacist)
e-mail: crc019*osaka-med.ac.jp（insert ＠ instead of * ）, 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
Forms required
Application Procedure Details (only in Japanese)