Drug Evaluation Committee 2019-38 Scope of site management organizations (SMOs) that should be included in clinical trial notifications (Part 2)
Related classification: outsourcing of work
Initial publication date: November 2019
Revised publication date: March 2021
Question
We have received information that a university hospital requested a clinical trial, and they have an SMO as a dispatch source, and have a worker dispatch contract with the SMO to dispatch a CRC as a temporary worker. we have also confirmed that this is not an outsourcing to an SMO based on Article 39-2 of the GCP.
According to the MHLW notice "Handling of Notification of Clinical Trial Plan for Drugs by a Person Who Wants to Request a Clinical Trial "*, the clinical trial plan notification form must include the following information: "When outsourcing part of the operations related to the conduct of a clinical trial at a site, the name and address of the person who will be entrusted with such operations and the scope of such operations to be entrusted must be entered for each site. However, in this case, the SMO is dispatching workers to the site, so we have determined that this does not fall under the above-mentioned outsourcing, and therefore, there is no need to include this information in the clinical trial plan notification, etc. Please let us know if this judgment is correct.
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As of December 2023(August 31, 2020, Pharmaceutical and Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, Drug Evaluation and Control Division Director Notification No. 0831-10)
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in the "Report of the Study Group for Establishment of Standard Guidelines for Use of SMO" (November 2002) by the Study Group of the Ministry of Health, Labour and Welfare, CRCs dispatched by an SMO are to perform their duties under the direction and orders of the investigators, etc. at the destination medical institution. In other words, this is a dispatch of workers to the site and does not constitute entrustment of clinical trial operations.
In the notification of the clinical trial plan, it is necessary to state the party to which the medical institution entrusts part of the work related to the implementation of the clinical trial, but in the case of worker dispatch as in your question, it is not necessary to do so.
Reason for revision
In accordance with the August 31, 2020 issuance of Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare, Drug Evaluation and Management Division Director Notification No. 0831-10, minor revisions have been made to the question text.