[Total quality management of clinical database].

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

Research output: Contribution to journalArticlepeer-review


Data entry system should be constructed considering utility, accuracy, propriety, and feasibility. The methods for developing useful and accurate clinical databases are 1)system development based on the concept of "error proofing", 2)system test by real users, 3)guidances for participants, and 4)incentive for accurate data entry. In terms of propriety, to gain patient's consent on data collection and to publicly announce objectives and methods of clinical database are necessary. Confidentiality and anonymization of data are also important. Balancing efficacy and propriety for maximization of patients' and societal benefit is one of the important responsibilities of database management organizations. In addition, assessment of data quality such as audit and feedback is useful for enhancing accuracy and reliability of clinical databases.

Original languageEnglish
Pages (from-to)485-489
Number of pages5
JournalUnknown Journal
Issue number6
Publication statusPublished - 2013 Jun
Externally publishedYes

ASJC Scopus subject areas

  • General Medicine


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