| 简介/内容概述： | The purpose of this document is to recommend international standards for, and promoteharmonization of, the general principles on planning, designing, and analyzing observational(non-interventional) pharmacoepidemiological studies that utilize fit-for-purpose data forsafety assessment ofmedicines (drugs, vaccines, and other biological products). This document outlines recommendations and high-level best practices for the conduct ofthesestudies, to streamline the development and regulatory assessment of study protocols andreports. These recommendations and practices also seek to improve the ability of the studyprotocol and/or results to be accepted across health authorities and support decision-making inresponse to study results. The Glossary defines several terms for the purpose ofthis guideline.Terms that appear in bold italic type upon first use are defined in the Glossary. |
