Drug Evaluation Committee 2010-35 CRC's description of the clinical trial drug control chart
Related classification: investigators, subinvestigators, etc.
First published: Jan. 2011
Question
If the SMO's SOP states that a clinical research coordinator (CRC) is responsible for "assisting in the management of investigational drugs" and the "scope of support services by the SMO" in the contract between the Investigator Site and the SMO states that the CRC dispatched by the SMO is responsible for "assisting in the management of investigational drugs," is there any problem if the CRC dispatched by the SMO describes the dispense section of the investigational drug management chart in the SOP? 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.
JPMA's Opinion
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. H-row, however, also explains that "work related to the preparation of drugs by pharmacists may not be outsourced or dispatched as workers.
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 between the Investigator Site and the SMO stipulates "investigational drug management assistance" as an outsourced service.
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The SOP of the Investigator Site stipulates the procedures and contents of "investigational drug management assistance services" to be performed under the guidance and supervision of the investigational 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.