[Total quality management of clinical database].

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

研究成果: Article査読


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.

ジャーナルUnknown Journal
出版ステータスPublished - 2013 6

ASJC Scopus subject areas

  • Medicine(all)

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