Drug Evaluation Committee 2022-55 Dispensing, auditing, and preparation services other than clinical trial management assistants
Related classification: Principal investigators, subinvestigators, etc.
First published: Apr 2023
Question
We would like to confirm a similar question to a previous question number 2012-26. At our hospital, investigational drug administration assistants are appointed by the investigational drug manager to perform their duties.
In order to reduce the workload of the assistant, is it possible for a general pharmacist to perform tasks other than investigational drug administration (preparation, auditing, and preparation of investigational drugs) as part of his/her regular duties under the supervision of the assistant and without delegation after receiving an explanation of the investigational procedures?
If this is possible, would it be desirable to include this in the standard operating procedures, and should we even prepare a staff list?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Due to the nature of investigational drugs, study-specific handling protocols may require that preparation (thawing/dissolving/dilution) of investigational drugs be performed under specified conditions. In some cases, such protocols require study-specific training for staff members who perform activities such as storage management, preparation, preparation, and assisting with medication administration. Even if the training is included in the Standard Operating Procedures as you suggest, it is necessary to record the implementation of training and delegation of tasks in the Training log and Delgetion log.
On the other hand, in the case of drug management in clinical trials where there are no such study-specific requirements (i.e., when drug storage and quantity control is performed according to procedures similar to those used in general medical dispensing), there are cases where general pharmacists work under the supervision of an investigational drug administration assistant and do not require study-specific training or a delgetion log. In some cases, there is no need for study-specific training or a Delegation log. Therefore, the scope of pharmacists, etc. to be included in the Delegation Log should be confirmed with the sponsor for each study protocol.
As for whether or not a staff list is required when a delegation log is not prepared, we believe that the work is within the category of drug administration in general practice, etc., and that separate preparation is not necessarily required as long as each individual can be identified in the records of the medical institution. However, there are cases where it may be necessary to create this list for each trial, so it would be advisable to consult with the sponsor.