Drug Evaluation Committee 2019-38 Scope of site management organizations (SMOs) that should be included in clinical trial notifications (Part 2)
Related classification: Outsourced operations
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 Ministry of Health, Labour and Welfare (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 state "When a part of operations related to the implementation of a clinical trial at an Investigator Site is entrusted, the name and address of the person entrusted with such operations and the scope of such entrusted operations must be entered for each Investigator Site. However, in this case, the SMO is dispatching workers to the Investigator Site, so we believe that this does not fall under the above-mentioned outsourcing, and therefore, it is not necessary to include this information in the clinical trial plan notification, etc. Please let us know if this judgment is correct.
- *(August 31, 2020 Ministry of Health, Labour and Welfare, Pharmaceuticals and Consumer Affairs Bureau, Director-General of the Drug Evaluation and Control Division, Drugs and Pharmaceuticals Evaluation and Control Department Notification No. 0831-10)
JPMA's Opinion
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, CRC dispatched by an SMO are to perform their duties under the direction and orders of the investigators, etc. at the Investigator Site to which they are dispatched. In other words, this is a dispatch of workers to Investigator 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 Investigator Site entrusts part of the work related to the conduct 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.