[关键词]
[摘要]
临床试验药品发放管理的模式是确保临床试验质量可控,保障受试者用药安全、数据真实可靠的关键环节。结合药物临床试验药品发放管理模式的实践,分析了临床试验药品发放管理的现状与挑战、药品发放管理模式的优化实践与对策,包括应用信息化管理、试验实施的优化和改进、优化受试者管理,以期为提升药物临床试验质量提供参考。
[Key word]
[Abstract]
The mode of clinical trial drug distribution management is a critical link in ensuring controllable quality of clinical trials, guaranteeing the safety of subjects' medication, and ensuring the authenticity and reliability of data. This article combines the practice of drug distribution management mode in clinical trials, analyzes the current situation and challenges of drug distribution management in clinical trials, optimization practices and strategies of drug distribution management mode, including the application of information management, optimization and improvement of trial implementation, and optimization of subject management, in order to provide reference for improving the quality of drug clinical trials.
[中图分类号]
R951
[基金项目]
苏州市科技计划项目(SLT2023027)