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[参与机构的注册工作流程及临床数据库中的数据审核]

[Work flow of registry in participating facilities and data audit in clinical database].

作者信息

Tomotaki Ai, Miyata Hiroaki, Okubo Suguru, Motomura Noboru, Murakami Arata, Ono Minoru, Iwanaka Tadashi

机构信息

Department of Healthcare Quality Assessment, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

出版信息

Kyobu Geka. 2013 Aug;66(9):827-32.

Abstract

Clinical database needs quality control and quality assurance of data. Medical staffs of facilities in clinical database need to confirm definitions of data submitted to clinical database and criteria of registered cases, and decide how to entry data before data entry. Especially good communication between surgeons and data managers becomes an important factor of data quality in facilities. Also, we need quality improvement initiatives based on high quality data. Clinical database has to assurance data quality. The indicators of data quality are, for examples, completeness of registration and accuracy of data entry and data quality is evaluated on data verification between data of clinical database and medical records in facilities. From these viewpoints, this article described about work flow of registry for participating facilities and medical staffs.

摘要

临床数据库需要对数据进行质量控制和质量保证。临床数据库中各机构的医务人员需要在数据录入前确认提交至临床数据库的数据定义和病例登记标准,并决定如何录入数据。特别是外科医生和数据管理人员之间良好的沟通成为各机构数据质量的一个重要因素。此外,我们需要基于高质量数据的质量改进措施。临床数据库必须确保数据质量。数据质量指标例如登记的完整性和数据录入的准确性,并且根据临床数据库数据与各机构病历之间的数据核对来评估数据质量。从这些观点出发,本文描述了参与机构和医务人员的登记工作流程。

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