临床试验数据管理质量评价指标体系

发布时间：2018-05-10 08:46

本文选题：临床试验 + 数据管理　；参考：《药学学报》2015年11期

【摘要】：临床试验数据质量管理体系是确保临床研究数据真实完整、一致可靠的关键。本文中所收录的临床试验数据管理评价指标,按照临床试验的进展过程归纳为在启动阶段、进行阶段及结束阶段分别适用的指标。在每一个进展阶段中,又依据数据质量ALCOA+原则列举了不同目的的评价指标,如体现数据完整性、准确性、及时性、可溯源性等方面的指标。最后列举了一些综合质量管理常用的相关指标。本文对每一个指标的定义、目的、评价结果、建议标准及达标要求等进行了逐一描述。力求详实具体,并具有实际可行的指导意义。建立完整可行的综合指标体系、全面管理临床试验数据质量,不仅可以帮助申办者或数据管理机构达到全面、系统、可持续管理单个临床试验数据质量的目的,同时也可以为综合评价多个项目之间、不同申办机构之间、以及不同数据管理机构之间的临床试验数据质量对比奠定基础,提供重要而且客观的实际依据,使建立行业通用的质量标准成为可能,并助力推动整个行业共同快速进步。
[Abstract]:The quality management system of clinical trial data is the key to ensure that clinical research data are true and complete, consistent and reliable. According to the progress of clinical trial, the evaluation indexes of clinical trial data included in this paper are summed up as the suitable indexes in the starting stage, the stage of proceeding and the stage of ending respectively. In each stage of development, according to the ALCOA principle of data quality, the evaluation indexes for different purposes are listed, such as reflecting data integrity, accuracy, timeliness, traceability and so on. Finally, it lists some commonly used related indexes of comprehensive quality management. This paper describes the definition, purpose, evaluation results, recommended standards and requirements of each index one by one. Strive to be detailed and specific, and have practical and feasible guiding significance. The establishment of a complete and feasible comprehensive index system and the overall management of the quality of clinical trial data can not only help the applicant or the data management organization to achieve the goal of comprehensive, systematic and sustainable management of the data quality of a single clinical trial, At the same time, it can also lay the foundation for comprehensive evaluation of the quality comparison of clinical trial data among multiple projects, between different bid organizations, and among different data management organizations, and provide an important and objective practical basis. Make it possible to establish general quality standards, and help promote the rapid progress of the industry.
【作者单位】：中国临床试验数据管理学组;
【分类号】：R95

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