Drug Evaluation Committee 2007-05 Necessity of Review of SOPs 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 36, Paragraph 1 of the GCP stipulates that the "protocols related to clinical trials" (hereinafter referred to as "SOPs of the implementing medical institution") are prepared under the responsibility of the head of the implementing medical institution, but there is no stipulation that the establishment or revision of such protocols must be reviewed by the Clinical Trial Review Committee.
In addition, the materials to be reviewed by the Clinical Trial Review Committee are as indicated in Article 32, Paragraph 1 of the GCP, but the SOP for the site of the implementing medical institution is not included. However, Article 32, Paragraph 1, Item 5 stipulates "other materials that the investigational review committee deems necessary," so if the investigational review committee of your hospital determines that the SOPs of the site are necessary for "reviewing whether the relevant clinical trial is appropriate to be conducted at the site," it may request the submission of such materials. 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 your hospital's Clinical Trial Review Committee determines that an investigational site SOP is necessary for its review, we recommend that you stipulate this in your hospital's Clinical Trial Review Committee's procedures and inform all participating medical institutions of the purpose of the committee's review and the SOP.