药物临床试验质量控制浅析

Analysis on Quality Control of Drug Clinical Trials

目的:建立有效的药物临床试验质量控制体系。方法:结合笔者多年的临床研究工作管理经验,对药物临床试验质量的关键环节和控制措施进行探讨并提出建议。结果与结论:药物临床试验质量控制的关键环节在于建立完善的组织管理体系、建立健全规章制度和科学规范的标准操作规程、严格执行《药物临床试验质量管理规范》和现行法规等,采取建立药物临床试验监查员准入制度、三级质控制度、临床数据电子化管理、药物临床试验申报平台、临床研究协调员制度等控制措施,以全面保证药物临床试验的质量。

OBJECTIVE： To establish an effective quality control system of drug clinical trials. METHODS： According to the experience of author on clinical research management in many years, key step and control measure of drug clinical trials were explored to put forward recommendations. RESULTS＆CONCLUSION： The key to quality control of drug clinical trials is to establish sound organization and management system, improve the regulation and scientific and standardized operation procedure, implement GCP, existing regulations, clinical trials of drug inspectors, access system for inspector, three degree of quality control system, clinical data electronic management, reporting platform for drug clinical trials, clinical research coordinator system and other mea- sures to fully guarantee the quality of drug clinical trials.