Drug Evaluation Committee 2010-35 CRC's description of the clinical trial drug control chart
Related classification: Principal investigators, subinvestigators, etc.
Date of first publication: January 2011
Question
If the SMO's SOP states that the duties of a clinical research coordinator (CRC) are to "assist in the management of investigational drugs" and the "scope of support services by the SMO" in the contract between the site and the SMO states that the CRC dispatched by the SMO is to "assist in the management of investigational drugs," there is no problem if the CRC dispatched by the SMO enters the disbursement section of the investigational drug management chart. Is there any problem if the CRC dispatched by the SMO describes the dispensing part of the investigational new drug management chart? If there is no pharmacist in the clinic, the director prescribes the investigational drug and the CRC assists in dispensing the drug accordingly.
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), "work related to the management of investigational drugs" is listed as "the scope of work that can be performed by an SMO. However, the report also explains that "work related to the preparation of drugs by pharmacists may not be performed by outsourcing or worker dispatch.
Therefore, "work related to the dispensing of drugs by pharmacists" cannot be performed, but auxiliary work can be performed under the following conditions.
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The contract agreement between the site and the SMO stipulates "investigational drug administration support services" as an outsourced service.
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The SOP of the site specifies the procedures and contents of "investigational new drug management support services" to be performed under the guidance and supervision of the investigational new drug manager.
In addition, we believe that a seal of confirmation from the investigational drug manager is required each time a drug is discharged, so that it is clear that the work to assist with the entry of the investigational drug control chart was performed under the guidance and supervision of the investigational drug manager.