Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Contemp Clin Trials. 2010 Nov;31(6):536-43. doi: 10.1016/j.cct.2010.08.010. Epub 2010 Sep 7.
An electronic safety reporting (ESR) module was developed and integrated into a home-grown web-based clinical trial management system (CTMS) to enhance the efficiency, completeness and consistency of reporting and reviewing serious adverse events, monitoring safety, and submitting safety reports to regulatory authorities for a large multicenter clinical trial. The architecture of this integrated module provided many advantages. First, the ESR module was developed based on a comprehensive procedure which incorporated both computer logic processing steps and human intervention steps in order to deal with the complex and unexpected situations where pre-programmed computer logic may fail. Second, safety and efficacy data were managed within the same relational database. Relevant data captured on efficacy case report forms, such as demographics, medical history, lab data and concomitant medications, were directly retrievable for MedWatch report composition without requiring redundant data entry. Finally, the ESR module shared the same generic user interfaces and data processing functions with other modules in the CTMS. These generic components include data editing, data retrieving, data reporting, dictionary-based automatic and interactive coding, event-driven and calendar-driven automatic email notifications, and user privilege management. This integrated ESR module was implemented in the Albumin in Acute Stroke (ALIAS) Trial-Part 1. A total of 397 serious adverse event reports were processed and 33 FDA MedWatch reports, 28 initial reports, and 5 follow-up reports were submitted to FDA and Health Canada using this system. Experiences and lessons learned from the development and implementation of this system are presented in this paper.
开发并集成了一个电子安全报告（ESR）模块到一个自主研发的基于网络的临床试验管理系统（CTMS）中，以提高报告和审查严重不良事件、监测安全性以及向监管机构提交安全性报告的效率、完整性和一致性，该系统用于一项大型多中心临床试验。该集成模块的架构具有许多优势。首先，该 ESR 模块是基于一个综合程序开发的，该程序结合了计算机逻辑处理步骤和人工干预步骤，以应对可能出现的复杂和意外情况，在这些情况下，预编程的计算机逻辑可能会失败。其次，安全性和疗效数据在同一个关系数据库中进行管理。在疗效病例报告表中捕获的相关数据，如人口统计学、病史、实验室数据和伴随用药，可以直接检索用于 MedWatch 报告的编写，而无需重复输入数据。最后，ESR 模块与 CTMS 中的其他模块共享相同的通用用户界面和数据处理功能。这些通用组件包括数据编辑、数据检索、数据报告、基于字典的自动和交互编码、事件驱动和日历驱动的自动电子邮件通知以及用户权限管理。这个集成的 ESR 模块已在 Albumin in Acute Stroke（ALIAS）试验 - 第 1 部分中实施。共处理了 397 份严重不良事件报告，并使用该系统向 FDA 和加拿大卫生部提交了 33 份 FDA MedWatch 报告、28 份初始报告和 5 份随访报告。本文介绍了该系统的开发和实施过程中获得的经验和教训。
