Drug Evaluation Committee 2017-06 Scope of Work for Dispatched CRC
Related classification: outsourcing of work
Date of first publication: June 2017
Question
We are an SMO that provides CRC services and administrative support services at implementing medical institutions.
We would like to ask your opinion on whether it is acceptable for SMO CRC to perform centrifugation work in the implementing medical institution. I could not find any clear evidence that it is not a medical practice. When a small medical institution like a clinic conducts a clinical trial, it is often refused to allow in-house staff to perform centrifugation of specimens when conducting a clinical trial because there is no clinical technologist on the in-house staff or because the specimen testing, including specimen processing, is outsourced to an external laboratory. However, we have found that this is not always the case. Our policy is that specimen centrifugation is considered to be a medical procedure, and we ensure that CRC at SMOs do not perform it. Until now, in the case of refusal by in-house staff at the stage of infrastructure development prior to the start of a clinical trial, we have repeatedly explained the situation to the investigator and others, and with their understanding, we have been able to have in-house staff such as nurses perform centrifugation work.
However, this time, at a certain clinic, the in-house staff did not perform centrifugal separation during normal medical services, and it was difficult for nurses and other in-house staff to perform centrifugal separation for a clinical trial, and in some other clinics, clerical staff performed centrifugal separation. Since other clinics may have clerical staff performing centrifugation, it is difficult to consider centrifugation as a medical practice, and they strongly requested that the SMO's CRC perform this work.
Since most CRC have medical qualifications such as nurses and clinical laboratory technicians, they are fully capable of performing the centrifugation work itself, but is there any problem (i.e., is it not considered medical practice) for the SMO CRC to perform centrifugation work as support work for the implementing medical institution?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to the "Report of the Study Group for Establishing Standard Guidelines for the Use of SMOs" (November 2002, Ministry of Health, Labour and Welfare), it is possible for SMOs to provide clerical support and assistance in the provision of medical care through worker dispatch, but not in the case of medical practice or medical assistance. However, it is not allowed to perform such work in the case of medical or medical treatment support services. Operation of centrifugation in clinical laboratory work is hardly considered clerical support and assistance work, and we believe that it is not appropriate for CRC dispatched from SMOs to perform such work.
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As of December 2023
Report of the Study Group to Establish Standard Guidelines for the Use of SMOs" (November 2002, Ministry of Health, Labour and Welfare)
(Excerpt)
"Among services related to the conduct of clinical trials and management of investigational drugs, services related to assisting medical practice and treatment and services related to dispensing drugs performed by pharmacists are not allowed to be performed by outsourcing or worker dispatch, and it is considered that SMOs cannot perform such services by outsourcing or worker dispatch. It is considered that SMOs cannot be commissioned or dispatched to perform such services. However, it is considered possible for SMOs to perform clerical support and assistance services related to the provision of medical care through worker dispatch.