摘要
目的Ⅰ期临床试验的生物样本管理质量直接影响临床试验结果的真实性和准确性。近几年生物样本管理问题已经是国内外十分关注的研究问题之一,本研究建立Ⅰ期临床试验生物样本的流程化管理体系,旨在提高生物样本质量和工作效率,为规范Ⅰ期临床试验的生物样本管理提供参考依据。方法从生物样本管理的规范化和信息化要求两个方面总结经验,阐述影响Ⅰ期临床试验生物样本质量的人员、标签标识、接收、转运、处理、设备、物资、标准操作规程(standard operating procedure,SOP)、文件管理和样本信息化管理等过程。结果依托生物样本信息管理系统、温度智能监控报警管理系统、专业的样本管理人员、完善的制度和SOP,建立了一套规范的生物样本流程化管理体系,提高了样本管理的质量。截至2020年12月底,共接受国家药监局现场核查42次,省药监局现场检查5次,免临床核查的试验共29个,涵盖60余个药物,均顺利通过核查。结论高质量的临床生物样本是Ⅰ期临床研究数据和结果的可靠性、完整性和科学性的核心因素之一。建立规范的流程化生物样本管理体系可提高药物临床试验的研究质量,能有效杜绝或减少临床试验生物样本流程化管理过程中样本转运、样本处理、出入库和日常管理等问题发生,保证药物临床试验结果的准确性、可比性和可重复性。
Objective The quality of biological sample management in phase Ⅰ clinical trials directly affects the authenticity and accuracy of clinical trial results.In recent years,the management of biological samples has become one of the research issues of great concern in China and abroad.This study established a process management system for biological samples in phase Ⅰ clinical trials,aiming to improve the quality and efficiency of biological samples and provide a reference for standardising biological sample management in phase Ⅰ clinical trials.Methods The experience from the standardisation and information requirements of biological sample management was summarised,and the procedures that affect the quality of biological samples in phase Ⅰ clinical trials,including personnel,labelling,reception,transfer,processing,equipment,materials,standard operating procedure(SOP),document management and sample information management,were described.Results A set of standardised process management system of biological samples has been established relying on biological sample information management system,temperature intelligent monitoring and alarm management system,professional sample management personnel,complete system and SOP to improve the quality of sample management.By the end of December 2020,it has been inspected on site by the National Medical Products Administration for 42 times and the provincial Medical Products Administration for 5 times,and exempted for inspection for 29 times,covering more than 60 drugs,all of which have passed the inspection successfully.Conclusion High-quality clinical biological samples are one of the core factors for the reliability,completeness and scientificity of phase Ⅰ clinical research data and results.The establishment of a standardised process of sample management system can improve the research quality of drug clinical trials,effectively prevent or reduce the occurrence of problems such as sample transportation,sample processing,in-and-out storage and daily management during
作者
曾丽艳
王倩
孟现民
柯晶
董华娟
卢洪洲
ZENG Li-yan;WANG Qian;MENG Xian-min;KE Jing;DONG Hua-juan;LU Hong-zhou(Clinical Research Center for Innovative Drugs,Shanghai Public Health Clinical Center,Shanghai 201500,China)
出处
《中华全科医学》
2021年第8期1403-1407,共5页
Chinese Journal of General Practice
基金
国家“重大新药创制”科技重大专项资助项目(2017ZX09304027)。
关键词
Ⅰ期临床试验
生物样本
信息化
流程化管理
Phase I clinical trials
Biological samples
Informationisation
Process management
