Pecoraro Fabrizio, Luzi Daniela
Institute for Research on Population and Social Policies (IRPPS), National Research Council, Rome, Italy.
Stud Health Technol Inform. 2011;169:834-8.
The paper describes the design of a module that manages Serious Adverse Events (SAEs) reporting within a Clinical investigation on Medical devices. This module is integrated in a Medical Device Information System (MEDIS) that collects data and documents exchanged between applicants and the National Competent Authority during the clinical investigation lifecycle. To improve information sharing among different stakeholders and systems MEDIS design and developed were based on the HL7 v.3 standards. The paper provides a conceptual model on SAEs based on HL7 RIM that underlines Medical Device characteristics.
本文描述了一个模块的设计，该模块用于管理医疗器械临床研究中的严重不良事件（SAE）报告。此模块集成在医疗器械信息系统（MEDIS）中，该系统在临床研究生命周期内收集申请人与国家主管当局之间交换的数据和文档。为了改善不同利益相关者和系统之间的信息共享，MEDIS的设计和开发基于HL7 v.3标准。本文提供了一个基于HL7 RIM的SAE概念模型，该模型突出了医疗器械的特性。
