Drug Evaluation Committee 2008-29 Investigational drug managers affiliated with related medical institutions
Related classification: Other
First published: January 2009
Question
Situation
The facility where the clinical trial will be conducted is a clinic, Clinic A (let's call it Clinic A), which has General Hospital B (let's call it General Hospital B) attached to it. The investigational drug manager for this clinical trial belongs to the Department of Pharmacy at B General Hospital.
Question
Are there any regulations for the person who is to be the study drug manager? (e.g., the person must belong to the site where the clinical trial is being conducted, etc.)
Also, as in this case, would a person who does not belong to the site of the clinical trial be unsuitable to be the study site manager? Is it sufficient to confirm that there is no problem even if the affiliation is different? We would appreciate it if you could provide us with any pointers on who should be an investigational drug manager.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 39 Guidance 2 of the GCP states that "The head of the site should appoint a pharmacist from the site as an investigational drug manager as a rule at ・・・・・. If a pharmacist cannot be appointed as an investigational drug manager, a physician or dentist from the site should be appointed. In the case of your question, the role of B General Hospital in the clinical trial is not clear, but in principle, a pharmacist who belongs to the "implementing medical institution" under GCP should be appointed as the investigational drug manager, and if this is not possible, a physician or dentist who belongs to the implementing medical institution should be appointed as the investigational drug manager.