临床数据管理中的文档管理

发布时间：2018-04-01 16:20

本文选题：临床试验主文档　切入点：数据管理　出处：《药学学报》2015年11期

【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。
[Abstract]:The Clinical trial quality Management Code (GCPs) states that all clinical trial information should be recorded, processed and preserved and can be accurately reported. Interpretation and verification. The clinical trial master document trial master fileTMFs are all relevant paper or electronic documents produced in clinical trials. As a retrospective analysis, A complete trial master document should be able to reproduce the clinical trial process completely. The clinical data management document is part of the trial master document. Accuracy and completeness is one of the important evidence to reflect the reliability of the data. This paper helps to understand what documents are required for each phase by understanding the data management processes at different stages of a clinical trial. The importance of data management documents to the reliability of data is understood. At the same time, how to manage good clinical data documents is expounded. Only on the basis of understanding the whole process of clinical data management, Strict and effective document management and regular quality control are the guarantee of high quality data management documents.
【作者单位】：美达临床数据技术有限公司;杭州泰格医药科技有限公司;
【分类号】：R95

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