Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting

Electronic Submission of Serious Adverse Events (SAE) Reports – E2b Reporting

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This document is intended to provide communication to various stakeholders conducting Clinical Trials to outline an additional method for reporting of Serious Adverse Events (SAEs) occurring during clinical trials.

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Document Number: CT03-2025/26
Version: 1
Date Updated: 23/12/2025
File Type: www
Category: Communication to industry
Unit: Clinical Evaluations Management, Clinical Trials