使用人类标本的体外诊断设备（IVD）的临床表现研究 - 良好的学习实践

[中文适用范围]： 本文件定义了临床性能研究的规划、设计、实施、记录和报告的良好研究实践，这些临床性能研究旨在评估用于监管目的的体外诊断 (IVD) 医疗器械的临床性能和安全性。 注 1：这些研究的目的是评估预期用户手中的 IVD 医疗器械的能力，以在预期人群中产生与特定医疗状况或生理/病理状态相关的结果。 该文件无意描述临床性能研究是否充分解决了相关 IVD 医疗器械的技术规范。 本文件确定了支持临床表现研究的原则，并规定了一般要求，旨在 — 确保临床表现研究的进行将产生可靠和稳健的研究结果， — 定义申办者和主要研究者的责任， — 协助申办者、临床研究组织、研究者、伦理委员会、监管机构和其他参与 IVD 医疗器械合格评定的机构，以及 — 保护提供用于临床性能研究的样本的受试者的权利、安全、尊严和福祉。 分析性能研究超出了本文档的范围。 注 2：当专门用于分析性能研究的样本采集给受试者带来额外的采集风险时，本文件的某些要素（特别是附件）可用于确保受试者安全。 出于上市前和上市后监管目的以外的其他原因（例如出于报销目的）进行的临床性能研究不属于本文件的范围。 注 3：本文件的一些要素可用于此类研究的设计，包括受试者安全性和数据完整性。 本文件不包括实验室工作人员或其他收集研究样本的人员的安全信息。 注 4：此类信息包含在其他出版物中[1][12][13]。 注5：本文件的使用者可以考虑其他标准和/或要求是否也适用于作为临床性能研究主题的IVD医疗器械，例如，在存在IVD医疗器械和医疗器械的情况下如果用于集成系统（例如刺血针、IVD 测试条和血糖仪），可以考虑本文件和 ISO 14155 的各个方面。 [外文原描述]： This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications [1][12][13] . NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.