标准摘要
[中文适用范围]： 本文件提供了关于设计和实施临床研究以确定新型宫内节育器性能特征的指南。它还提供了关于研究完成后数据分析以及制造商、研究人员和监管机构对这些结果解读的建议。本文件未涉及某些临床试验问题，包括参与者补偿、参与者及其记录的保密性、当地伦理委员会的使用等。这些问题以及许多其他临床试验设计问题在ISO 14155中有详细说明。 [外文原描述]： This document provides guidance on the design and conduct of clinical studies to determine the performance characteristics of new intrauterine devices. It also provides advice on the analysis of data when the study is completed, as well as interpretation of these results by manufacturers, researchers and regulatory bodies. Certain clinical trial concerns are not addressed in this document, including participant compensation, confidentiality of participants and their records, use of local ethics committees, etc. These and many other clinical trial design issues are covered in great detail in ISO 14155.
英文名称Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies