Drug Evaluation Committee 2014-32 Report of Serious Adverse Events in the Absence of the Investigator (Part 2)
Related classification: Adverse drug reaction reports
Date of first publication: December 2014
Question
Background
According to the response to Clinical Trial 119, 2008-10 "Reporting Serious Adverse Events in the Absence of the Principal Investigator," the view that it is unavoidable to report serious adverse events (SAEs) even if the person reporting the event is a subinvestigator is reported. However, with the recent development of the communication environment, it has become easier to communicate information with investigators outside the site by using e-mail, telephone, and web conferencing. In addition, the "New Uniform Form for Requesting Clinical Trials" indicates that the seal on the uniform form can be omitted, and depending on the clinical trial, the sponsor may request a report in EDC or other formats.
Question
In such a situation, if a clinical investigator on an overseas business trip can receive a report from a subinvestigator on the occurrence of SAEs and make necessary judgments on causal relationship, severity, etc. based on the contents of the report, the clinical investigator can make a SAE report directly from the place of business trip, or the investigator can make a SAE report from the site of the study, or the investigator can make a SAE report from the site of the study. Is it possible for a subinvestigator or a collaborator to prepare an SAE report based on the investigator's instructions and report under the investigator's name after confirmation of the contents by the investigator?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The 2008-10 assumes a case in which the investigator is unable to contact the principal investigator and the investigator is not in a position to promptly prepare an SAE report. If, as in the case in question, the principal investigator is not in the hospital (i.e., not at home), but the investigator is in a situation where he/she can make an appropriate decision on the SAE based on the contents of the report based on the examination by the subinvestigator, then there is no problem with either of the responses you have provided. Since the SAE report is to be submitted in the name of the investigator without his/her signature and seal, it is necessary to keep a record that the investigator's confirmation of the contents of such report has been obtained.