Drug Evaluation Committee 2019-19 Necessity of inclusion in the investigational drug administrator's delegation log
Related classification: Other
First published July 2019
Question
Please explain the necessity of the description of investigational drug administrators and administrative assistants in the delegation log.
We are aware that investigational drug administrators are not assigned duties by the investigator under J-GCP, but are appointed by the head of the site at the SOP level. We also recognize that they can participate in deliberations and voting at the Clinical Trial Review Committee. However, in discussions within our company, we are often admonished with the logic that investigational drug managers are not allowed to participate in clinical trial review committees because they are always specified in the delegation log as stipulated in ICH-GCP and are responsible for their duties. In addition, I have also seen past Clinical Trial 119 opinions that the work involved with investigational drugs is no different from general pharmacist work as long as the work involves reading the pharmacy manual and properly managing, storing, and dispensing the investigational drugs. As long as the work is general pharmacist work, is there a need for special delegation even if the drug is an investigational drug?
Pharmaceutical Association's view
According to ICH-GCP, the person who should be listed in the Delegation Log is the person who is responsible for important tasks in the clinical trial. Since the investigational drug manager is in charge of important tasks as he/she manages and dispenses the investigational drug, he/she is generally considered to be listed in the Delegation Log. On the other hand, it is recommended to consult with the sponsor to determine who should be listed in the Delegation Log, as it may vary depending on the sponsor's concept and the content of the study protocol.
Even if the investigational drug manager is listed in the Delegation Log, there is no problem if he/she participates in the deliberation and voting of the clinical trial (see past Opinions 2009-40 and 2017-11 ).