Drug Evaluation Committee 2017-83 Permission for Members in Charge of Investigational Drug Management to Participate in the Discussion and Vote of the Clinical Trial Review Committee (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: June 2018
Question
I have a question regarding Clinical Trial 119 Opinion " 2009-40 Permit/deny participation of Investigational New Drugs Management Committee members in deliberations/votes ".
As stated in ICH-GCP, we consider it undesirable for investigational drug managers (including assistants) to participate. Currently, due to the opinion of Clinical Trial 119, we have been unable to obtain the understanding of the investigational sites, and currently a delegated pharmacist is participating in the deliberation and vote.
Therefore, we would like to know the following two points.
Question 1
As stated in Article 39 Guidance 2 of the GCP, an investigational drug manager is a pharmacist appointed by the Chairperson of the site "to ensure that all investigational drugs are properly managed at the site" and is considered "a person who is not related to the principal investigator".
Question 2
Normally, a delegated pharmacist performs not only administrative duties but also dispensing duties. Or, if the investigator is in charge of a part of the work to be performed by the investigator ( other than investigational drug administration), is the investigator considered to be a collaborator appointed by the investigator?
JPMA's Opinion
An investigational drug manager is appointed by the head of the site to ensure that all investigational drugs are properly managed at the site (GCP Article 39 Guidance 2). As stated in a previous opinion ( 2009-40 ), in general, the duties of an investigational drug manager can be considered as "a person who is not related to the principal investigator" because he/she is not expected to be directly involved in the observation and examination of subjects and evaluation of data in the trial, considering the role stipulated in the GCP. Therefore, they can be regarded as "persons unrelated to the principal investigator". Therefore, there is no problem for them to participate in the deliberation and voting on the clinical trial as a member of the investigational review committee.
In addition, the investigational drug administrator (assistant) dispenses and dispenses investigational drugs based on the prescriptions of the investigators, etc., but such duties are also those of a general pharmacist, except in special cases, so there should be no problem in participating in deliberations and voting in the same manner.
However, in cases where the investigational drug (assistant) manager goes beyond the duties of a general pharmacist and is involved in double-blind drug allocation or requires special knowledge and skills in investigational drug management, there is a possibility that he/she will have a significant impact on the implementation of the trial. Therefore, it is not appropriate to participate in the deliberation of the clinical trial as a Clinical Trial Review Committee member.
In light of the above, the view of Clinical Trial 119 is basically no different from the view of the Q&A in your question.