Drug Evaluation Committee 2014-09 Discharge of Investigational Medicinal Products in the Absence of an Investigational Drug Manager
Related classification: Other
Date of first publication: Jul 2014
Question
In a study being conducted at a 2-physician clinic, if the investigator who is the study drug administrator is absent on the day of the subject's visit due to illness, is it possible for a subinvestigator who is not the study drug administrator assistant to dispense the study drug under the guidance of the investigator via telephone, etc.?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Normally, the investigational drug should be dispensed on a day when the investigational drug manager, who has been assigned this task in advance, is available. However, if the investigational drug manager judges that it is necessary as an emergency measure to avoid the burden and safety of the subject, it may be unavoidable for the investigational drug to be dispensed by a subinvestigator. However, the "Procedures for the Management of Investigational Medicinal Products However, it is necessary for the investigational new drug to be handled in accordance with the "Procedures for Management of Investigational New Drugs" and for the investigational new drug manager to record and preserve the circumstances of this situation at a later date and at an early stage.
In order to avoid a similar situation from occurring in the future, please consider appointing the said investigator as a backup investigational drug manager.