临床试验的电子数据采集技术指导原则.pptVIP

3.EDC系统的基本要求 系统验证和版本控制 -系统上线运行(包括系统升级版本或升级相关板块)之前完成验证 -系统验证SOP -相关文档齐全 验证计划书、测试脚本、结果、报告等 -版本控制SOP -确保系统升级后能正确地读取原有数据，而不会对原有数据造成任何修改或丢失 Validation “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.” FDA Guidelines on General Principles of Process Validation, May 1987 “Confirmation by examination and provision of objective evidence that software specificat