Drug Evaluation Committee 2016-16 Change in the Form of Establishment of a Clinical Trial Review Committee Establisher
Related classification: Clinical Trial Review Committee
Date of first publication: August 2016
Question
One organization that currently has a Clinical Trial Review Committee as a non-profit organization is considering becoming a public interest incorporated association in the future after becoming a general incorporated association. However, the "establisher of a clinical trial review committee" stipulated in Article 27 of the GCP does not include a public interest incorporated association, so we would like to know the following.
-
(1)If the organization becomes a public interest incorporated association, can it continue to establish a Clinical Trial Review Committee?
-
(2)If so, are there any requirements for such an organization? (For example, it must meet the requirements of GCP Article 27, Paragraph 2, etc.)
JPMA's Opinion
-
(1)As stated in the Act on Authorization of Public Interest Incorporated Associations and Public Interest Incorporated Foundation (Act No. 49 of June 2, 2006), a public interest incorporated association is a public interest incorporated association. Therefore, a public interest incorporated association is a type of general incorporated association and can establish a Clinical Trial Review Committee.
-
(2)As a general incorporated association, it is required to satisfy the provisions of Article 27, Paragraph 2 of the GCP.