Drug Evaluation Committee 2014-32 Report of Serious Adverse Events in the Absence of the Investigator (Part 2)
Related classification: Report of adverse drug reactions, etc.
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 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 who is traveling abroad can receive a report from a subinvestigator on the occurrence of SAE and make necessary judgments on causal relationship and severity based on the contents of the report, is it possible for the clinical investigator to make a SAE report directly from the site of travel, or is it possible for a subinvestigator or collaborator of the Investigator Site to make a SAE report in the clinical investigator's name after the content of the report has been confirmed by the clinical investigator? Is it possible for a subinvestigator or a collaborator to prepare an SAE report based on the investigator's instructions and report it under the investigator's name after the content is confirmed by the investigator?
JPMA's Opinion
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, 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.