E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

Post approval safety data management


The Guideline was finalised, under Step 4 of the ICH process, on November 12, 2003. This document provides a standardized procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition. The practices of the data management were standardized in such cases obtained from consumers, literatures, internets which are all specific to post-approval data management. Good case management practice was focused and recommended for expedited reporting with clear definitions.