【CODEX翻译】真实世界数据用于医疗器械临床评价

技术指导原则（试行）-英文版

真实世界数据用于医疗器械临床评价技术指导原则（试行）

 Technical Guideline for Application of Real-World Data to Clinical Evaluation of Medical Devices (Tentative)

      本指导原则旨在初步规范和合理引导真实世界数据在医疗器械临床评价中的应用，为申请人使用医疗器械真实世界数据申报注册以及监管部门对该类临床数据的技术审评提供技术指导。本指导原则中提及的医疗器械包括体外诊断试剂。

This Guideline is aimed to preliminarily regulate and properly guide the application of real-world data (RWD) to clinical evaluation of medical devices, and to provide technical guidance for applicants to apply for device registration using the RWD of medical devices and for the regulatory authorities to evaluate such clinical data. The medical devices mentioned in this Guideline include in-vitro diagnostic reagents.

本指导原则是供申请人和审查人员使用的技术指导文件，不作为法规强制执行，应在遵循相关法规的前提下使用本指导原则。真实世界数据和真实世界研究处于快速发展阶段，本指导原则基于现有认知水平制定，需根据科学发展不断完善和修订。

This Guideline is a technical guidance document for applicants and reviewers and shall not be enforced as laws or regulations. This Guideline shall be used on the premise of compliance with relevant laws and regulations. With the rapid development of RWD and real-world study (RWS), this Guideline, formulated based on the current cognitive level, needs to be subject to constant improvement and revision with the scientific development.

一、概述

1. Overview

（一）真实世界数据与证据

1.1 Real-world data and evidence

本指导原则所述真实世界数据是指传统临床试验以外的，从多种来源收集的各种与患者健康状况和/或常规诊疗及保健有关的数据。

For the purpose of this Guideline, the real-world data refers to the data related to the patient’s health status and/or routine diagnosis and treatment and healthcare collected from multiple sources other than those from traditional clinical trials.

围绕相关科学问题，综合运用流行病学、生物统计学、循证医学等多学科方法技术，利用真实世界数据开展的研究统称为真实世界研究。真实世界研究通过系统性收集真实世界数据，运用合理的设计和分析方法，开展前瞻或回顾性研究。

Studies on relevant scientific questions and conducted by comprehensively utilizing multidisciplinary approach and techniques including epidemiology, biostatistics and evidence-based medicine (EBM) and using RWD are collectively referred to as real-world study (RWS). RWS conducts prospective or retrospective studies by systematically collecting RWD and using reasonable design and analytical methods.

      CODEX北京科译翻译有限公司是一家专业提供生命科学翻译和本地化服务的公司，作为中国专业的生命科学翻译公司之一以及国内为数不多的通过国际ISO17100: 2015认证的医学翻译提供商，CODEX科译拥有更多的医学资深语言专家，能实现40多种语言对的互译，接受更高难度的医学领域的项目挑战，并在最短时间内适应以给出最合理的解决方案。保证最高质量，100%按时交付，高效、完善的售后保障是CODEX科译给客户的用心承诺。