Drug Evaluation Committee 2017-22 Clinical Laboratory Technicians' Concurrent Duties as Clinical Trial Drug Administration Assistants
Related classification: Investigational drugs
Date of first publication: October 2017
Question
I have a question about clinical technologists working as an investigational drug administration assistant.
If I read the GCP, there is no mention of limiting the work to pharmacists (except for dispensing and prescribing, of course), and the hospital's SOP does not say that the work is limited to pharmacists, is there any problem in 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?
JPMA's Opinion
The definition and scope of investigational drug administration assistants are not stipulated in GCP. On the other hand, investigational drug managers are to be appointed from pharmacists at Investigator Site (or from physicians or dentists if they cannot be appointed) (Article 39 Guidance 2 of GCP). Therefore, we believe that the assistant for investigational drug management who performs part of the duties to be performed by the investigational drug manager 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.