Drug Evaluation Committee 2012-26 Handling of Investigational New Drugs by Persons Other Than Investigational New Drug Administrators and Assistant Clinical Research Administrators
Related classification: Principal investigators, subinvestigators, etc.
Initial release date: October 2012
Revised publication date: December 2021
Question
Currently, only investigational drug dispensers and assistants are allowed to dispense investigational drugs, collect residual drugs from subjects, and record the associated investigational drug control charts in our hospital's Pharmacy Department. However, limiting the number of pharmacists who can perform these tasks may interfere with operations, and we are considering allowing all pharmacists to perform these tasks if there is no legal basis or need for it. However, it is not specified in such detail.
Please tell us your opinion whether it is acceptable for all pharmacists other than the investigational drug manager and assistant investigator to perform these tasks as long as the investigational drug manager fully informs the pharmacists of the handling methods and the investigational drug manager ultimately confirms (approves with signature and seal) the records in the investigational drug management chart.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In accordance with Article 39 of the GCP, the investigational drug manager is responsible for the appropriate management of investigational drugs in accordance with the procedure manual for investigational drugs provided by the sponsor. If it is necessary to assign someone other than the investigational drug manager to perform part of the investigational drug management duties, there should be no problem as long as the investigational drug is properly managed under the supervision and responsibility of the investigational drug manager after explaining the investigational drug protocol to the person to be assigned to the job.
It is recommended that the standard operating procedures of the site specify in advance who is to be engaged in the management of investigational drugs (e.g., by job title, description of the method of appointing individual persons to be engaged, etc.).
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).