Drug Evaluation Committee
2008-38 Scope of a site management organization (SMO) to be included in the clinical trial notification
Related classification: Clinical trial contract procedures
First published: Mar. 2009
Revised publication date: Mar 2021
Question
Please tell us if we are considered a site management organization (SMO) if we only ask a contractor to provide secretariat services for the Clinical Trial Review Committee.
However, there is an opinion that the medical institution asks the review committee for its opinion on the implementation of the clinical trial, and the operation of the review committee does not constitute a part of the requested clinical trial. Is it correct to think that even if a clinical trial review committee is established by the executing medical institution, the SMO does not need to submit a notification of the clinical trial to the authorities?
Also, if we request a review by a clinical trial review committee established by a company other than the site and the company acts as the secretariat of the clinical trial review committee, do we need to notify the company as an SMO? I don't think so, since there is no contractual relationship between the site and the contractor.
JPMA's Opinion
In the "Report of the Study Group for Establishing Standard Guidelines for the Use of SMOs" (November 2002) by the Study Group of the Ministry of Health, Labour and Welfare, "services related to the Clinical Trial Review Committee" is listed as a scope of services that can be performed by an SMO.
In addition, in "(Attachment 1) Items to be Notified in the Notification of Clinical Trial Plan, etc." of "Handling of Notification of Clinical Trial Plan for Drugs by a Person Who Wants to Request a Clinical Trial (No. 0831-10 issued by the Pharmaceutical Affairs Agency on August 31, 2020)," it is stated that "(In the notification of a clinical trial plan, etc.), when a part of operations related to the conduct of a clinical trial at an investigational medical institution is outsourced, the following items should be notified. In the case of partial outsourcing of operations related to the implementation of clinical trials at the site, the name and address of the person outsourcing such operations and the scope of the operations to be outsourced must be entered for each site".
If a clinical trial to be conducted at a site is reviewed by a clinical trial review committee established by the Chairperson of the site, an SMO that supports the operation and administrative work of the clinical trial review committee is considered to be subject to notification in the clinical trial plan, etc. On the other hand, if a clinical trial to be conducted at an external site is reviewed by a clinical trial review committee, an SMO that supports the operation and administrative work of the clinical trial review committee is considered to be subject to notification in the clinical trial plan, etc. On the other hand, if the request for review is made to an outside Clinical Trial Review Committee, the SMO is not considered to be subject to notification of the clinical trial plan, etc., because it provides operational support unrelated to the site where the clinical trial is being conducted.
Reason for revision
The opinion text has been partially changed in accordance with the issuance of the Notice on Notification of Clinical Trials (No. 0831-10 issued on August 31, 2020 by the Pharmaceutical Affairs Bureau of Japan).