title: [Total quality management of clinical database].
abstract: 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.
authors.affiliation: Department of Healthcare Quality Assessment, The University of Tokyo, Tokyo, Japan.
authors.forename: Suguru
authors.initials: S
authors.lastname: Okubo
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Miyata
authors.forename: Ai
authors.initials: A
authors.lastname: Tomotaki
authors.forename: Noboru
authors.initials: N
authors.lastname: Motomura
authors.forename: Arata
authors.initials: A
authors.lastname: Murakami
authors.forename: Minoru
authors.initials: M
authors.lastname: Ono
authors.forename: Tadashi
authors.initials: T
authors.lastname: Iwanaka
mesh_terms: D003625:Data Collection; D019992:Databases as Topic; D016208:Databases, Factual; D006801:Humans; D012107:Research Design; D017749:Total Quality Management