Drug Evaluation Committee June 2017 Scope of Duties for Dispatched CRCs
Related Category: Outsourcing of Operations
Initial Publication Date: June 2017
Question
Our company is an SMO that performs CRC duties and administrative support functions at Investigator Sites.
I am writing to ask for your opinion on whether it is acceptable for an SMO’s CRC to perform centrifugation tasks at an Investigator Site. I have been unable to find clear evidence that this does not constitute a medical procedure.When small-scale medical institutions, such as clinics, conduct clinical trials, there are often cases where they refuse to allow their in-house staff to perform centrifugation of specimens. This is frequently due to reasons such as the absence of a clinical laboratory technologist on staff or the outsourcing of specimen testing—including specimen processing—to an external laboratory.As a matter of company policy, we consider the centrifugation of specimens to be a medical procedure and strictly instruct our SMOs’ Clinical Research Coordinators (CRCs) not to perform it.In the past, during the infrastructure preparation phase prior to the start of a clinical trial, if we encountered resistance from in-house staff, we would explain the situation repeatedly to the principal investigator and others until we gained their understanding, and were then able to have in-house staff—such as nurses—perform the centrifugation.
However, in this particular case at a certain clinic, since hospital staff do not perform centrifugation as part of their regular clinical duties, it was deemed difficult for nurses or other hospital staff to perform this task specifically for the clinical trial.Furthermore, since administrative staff sometimes perform centrifugation at other clinics, they strongly requested that the SMO’s CRC perform the task, arguing that centrifugation is difficult to classify as a medical procedure.
Since most CRCs hold medical licenses—such as those of nurses or clinical laboratory technologists—they are fully capable of performing centrifugation tasks themselves. However, is it acceptable (and does it not constitute a medical procedure) for an SMO’s CRC to perform centrifugation as part of support services for the Investigator Site?
JPMA's view
The “Report of the Study Group on the Formulation of Standard Guidelines Concerning the Use of SMOs” (November Heisei 14, Ministry of Health, Labor and Welfare) states that while SMOs may perform administrative support and auxiliary tasks related to the provision of medical care through worker dispatch, they may not perform tasks that constitute medical practice or assist in medical treatment.Since the operation of centrifuges in clinical testing is difficult to classify as administrative support or auxiliary work, we believe it is inappropriate for a CRC dispatched by an SMO to perform such tasks.
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“Report of the Study Group on the Formulation of Standard Guidelines for the Use of SMOs” (Heisei 14, November, Ministry of Health, Labor and Welfare)
(Excerpt)
“Among the tasks related to the conduct of clinical trials and the management of investigational drugs, tasks that assist in medical practice or diagnosis, as well as tasks related to dispensing performed by pharmacists, are prohibited from being carried out through outsourcing or worker dispatch; therefore, it is considered that an SMO cannot perform such tasks through outsourcing or worker dispatch.However, it is considered that SMOs may perform administrative support and auxiliary tasks related to the provision of medical care through worker dispatch.”