研究机构疫苗临床试验质量管理体系建设探讨

Construction of Quality Management System for Vaccine Clinical Trials in Research Institutions

目的:建立完善的研究机构疫苗临床试验质量管理体系,规范临床试验全过程,保证疫苗临床试验质量。方法:收集相关文献并结合本机构近10年疫苗临床试验实践经验,从研究机构质量保证体系的建立与质控活动的实施入手,探讨研究机构疫苗临床试验质量管理体系建设。结果:研究机构建立的质量管理体系通常由质量管理人员、系统标准文件、现场设施设备、质量控制活动组成。在临床试验实施过程中需要质量管理人员之间密切配合、严格遵守系统标准文件,并按照质量控制计划的要求实施,才能有效保证临床试验过程的规范性和真实性。结论:质量管理是保证临床试验结果科学、可靠、真实的重要手段,应贯穿于整个临床试验过程。研究机构建立完善的质量管理体系对疫苗临床试验的质量及试验结果的可靠性有重要作用。

Objective:To establish an optimal quality management system for vaccine clinical trials,standardize the whole process of clinical trials and ensure the quality of vaccine clinical trials in research institutions.Methods:Through literature search and combined with the practical experience of vaccine clinical trials,this paper discussed the construction of vaccine clinical trial quality management system in research institutions from the establishment of quality assurance system and the implementation of quality control activities.Results:The quality management system established by research institutions was usually composed of quality management personnel,system standard documents and quality control activities.In the process of clinical trial implementation,close cooperation among quality management personnel,strict compliance with system standard documents and implementation in accordance with the requirements of quality control plan were required to effectively ensure the standardization and authenticity of clinical trial process.Conclusion:Quality management is an important method to ensure scientific,reliable and real clinical trial results,and should be implemented through the whole clinical trial process.The establishment of an optimal quality management system in research institutions plays an important role in the quality of vaccine clinical trials and the reliability of test results.