Global Health Economics, CSL Behring, Biotherapies for Life, King of Prussia, PA, USA.
Value Health. 2013 Jun;16(4):480-9. doi: 10.1016/j.jval.2013.04.002.
Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.
在医学文献中，有许多高质量、可靠的患者报告结局（PRO）数据的例子，这些数据是通过电子方式直接输入的，即电子患者报告结局（ePRO），与从纸质原始结果中输入的数据相比。临床试验管理者越来越多地使用 ePRO 数据收集来进行基于 PRO 的终点研究。监管审查规定了遵循 ePRO 数据收集的规则，以用于医疗标签声明。监管合规的一个关键组成部分是证明这些电子数据采集系统的验证。电子系统的验证是一个过程，而不是一个在单点完成的集中活动。有八个步骤需要描述和执行，以证明数据采集软件在其目标环境中的验证：需求定义、设计、编码、测试、跟踪、用户接受测试、安装和配置以及退役。这些要素与最近关于系统验证的监管指南一致。本报告旨在解释验证过程如何为赞助商、试验团队和其他负责验证从电子数据采集设备输入到关系数据库中的数据质量的电子数据采集设备的用户工作。它是一份关于数据采集系统供应商所需的要求和文档的指南，以证明系统验证。它是研究团队的实用信息来源，可确保 ePRO 提供商使用系统验证和实施流程，以确保系统和服务：在实际使用中可靠运行；生成准确和完整的数据和数据文件；支持管理控制并符合任何现有法规。此外，本简要报告将增加用户对技术审查要求的理解，从而对电子数据采集方法做出更明智和平衡的建议或决策。
