摘要
临床试验质量管理规范(GCP)规定所有临床试验的信息应该被记录、处理和保存并能被准确地报告、解释和核查。临床试验主文档(trial master file,TMF)是临床试验中产生的所有相关的纸质或电子文档。作为一种回顾性分析,一个完整的试验主文档应可以完整地再现临床试验的过程。临床数据管理文档是试验主文档的一部分,其准确完整性是反映数据真实可靠性的重要证据之一。本文通过了解临床试验不同阶段的数据管理流程而帮助了解每个阶段需要哪些文档,并理解数据管理文档对数据真实可靠性的重要性。同时阐述了如何进行良好的临床数据文档管理,只有在切实地理解临床数据管理的全过程的基础上,进行严格而有效的文档管理和定期的质量控制才是高质量数据管理文档的保证。
ICH GCP requires that all information of clinical trial should be recorded, processed, and storedin a way that allows the accurate reporting, interpretation and verification. A trial master file （TMF） containsall paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis,the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMFprofiles, both the accuracy and completeness of clinical data management documentation are important in dataintegrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial,to understand which documents are essential, and why the documentation of clinical data management isimportant for data integrity. This paper elaborates how to perform the good documentation practice of clinicaldata management, and suggests that both the precise and efficient document management and regular qualitycontrol may ensure the high quality of clinical data documentation management on the basis of an intensiveawareness of the overall process of clinical data management.
出处
《药学学报》
CAS
CSCD
北大核心
2015年第11期1410-1414,共5页
Acta Pharmaceutica Sinica
关键词
临床试验主文档
数据管理
文档管理
数据真实可靠性
trial master file
clinical data management
documentation management
data integrity
