Drug Evaluation Committee 2014-45 Description of the person establishing the clinical trial review committee in the notification of clinical trial
Related classification: Other
Date of first publication: April 2015
Question
According to the "Handling of Notification of a Clinical Trial Plan for a Drug by a Person Who Wants to Request a Clinical Trial" issued on May 31, 2013 by the Director of the Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, in case an external Clinical Trial Review Committee is used, the name (corporate name and representative name) of the establisher of the said Clinical Trial Review Committee should be stated in the clinical trial notification. However, the hospital's in-house clinical trial review committee and the committee's representative are not required to be included in the notification of clinical trial. However, in the case of an in-house or joint clinical trial review committee, the name of the establisher of the committee is not required. Therefore, even if only the name of the establisher (name of the corporation) of an external clinical trial review committee is stated in the notification of clinical trial, it will not affect the protection of human rights and safety of subjects, the scientific quality of the clinical trial, and the reliability of the results.
JPMA's Opinion
For the Investigational Review Committee as a notification item related to the clinical trial plan, "The name (name of the corporation and name of the representative) and location of the investigational review committee shall be entered for each Investigator Site." In principle, the following is required.
For the Investigator Site's Chairperson, it is possible to omit these items by entering "In-Hospital IRB" because the name and location of the investigator and the location of the committee are clear. However, when an external IRB is requested to deliberate on a clinical trial, the location of the IRB must be stated because the location of the IRB is not clear from the name of the establisher of the IRB alone.
In the case of a joint investigational review committee, the name of the investigational review committee is used instead of the name of the establisher because there are multiple establishers, but the location of the secretariat is required.