Drug Evaluation Committee 2007-05 Necessity of Review of Investigator Site SOP by External Clinical Trial Review Committee
Related classification: Other
Date of first publication: August 2007
Question
Our hospital has been entrusted with a clinical trial review committee for clinical trials conducted at participating medical institutions in our network.
Until now, when SOPs were revised at each medical institution, some medical institutions provided SOPs to our hospital, to which the clinical trial review committee is entrusted, while others did not, resulting in a disparity.
If there is a clinical trial review committee within the medical institution, SOP revisions are made after deliberation and approval by the clinical trial review committee. We are confused because each medical institution has a different view. There are medical institutions that do not discuss or report to the Clinical Trial Review Committee but provide SOPs, medical institutions that neither report nor provide SOP revisions to the Clinical Trial Review Committee, and so on.
As a medical institution entrusted with a clinical trial review committee, we would like to ask each medical institution to unify their SOPs.
JPMA's Opinion
Article 36, Paragraph 1 of the GCP stipulates that the Investigator Site SOP is to be prepared under the responsibility of the Chairperson of the Investigator Site, but there is no stipulation that the establishment or revision of the SOP must be reviewed by the Investigator Site SOP Review Committee.
The materials to be reviewed by the Investigator Site SOP are as specified in Article 32, Paragraph 1 of the GCP, but Investigator Site SOPs are not included. However, Article 32, Paragraph 1, Item 5 stipulates "Other materials deemed necessary by the Investigator Site SOP. If the SOP for the site is deemed necessary for your hospital's Clinical Trial Review Committee to "review whether the clinical trial is appropriate to be conducted at the site", it is appropriate to request submission of the SOP.
If the Investigator Site SOP is deemed necessary for review by the Clinical Trial Review Committee of your hospital, we recommend that you stipulate this in your hospital's Clinical Trial Review Committee Procedures and disseminate it and its purpose to all participating medical institutions in the network.