Drug Evaluation Committee 2017-22 Concurrent Duties of Clinical Laboratory Technicians as Clinical Trial Medication Administrative Assistants
Related classification: Investigational drugs
Date of first publication: October 2017
Question
This question is about clinical technologists working as an investigational drug administration assistant.
I have read the GCP and there is no mention of limiting the work to pharmacists (except for dispensing and prescribing, of course), and there is no mention in the hospital SOP of limiting the work to pharmacists, so I would not have a problem with bringing in and returning investigational drugs. Is it correct to say that there is no problem with the pharmacist handling the delivery and return of investigational drugs?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The definition and scope of duties of an assistant investigational drug manager are not specified in GCP. On the other hand, investigational drug administrators are to be appointed from pharmacists at the site (or physicians or dentists if they cannot be appointed) (GCP Article 39 Guidance 2). Therefore, we believe that an investigational new drug administration assistant who performs part of the duties to be performed by the investigational new drug administrator should be a pharmacist.
However, this does not apply to clerical work that can be performed under the guidance and supervision of the investigational drug manager, even if the assistant does not have the expertise as a pharmacist. When a non-pharmacist is appointed as an investigational new drug administration assistant, the type of work to be performed should be determined in advance and confirmed with the sponsor before the non-pharmacist is assigned. Please also refer to Opinion 2010-35.