Establishment of a data management scheme in clinical research combined with useful tools

2021 Fiscal Year Final Research Report

• Project/Area Number: 17K01438
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Medical engineering assessment
• Research Institution: National Institute of Public Health (2018-2021); Wakayama Medical University (2017)
• Principal Investigator: Doi Mariko 国立保健医療科学院, その他部局等, 主任研究官 (70636860)
• Co-Investigator(Kenkyū-buntansha): 岡田 昌史 東京大学, 医学部附属病院, 特任講師 (70375492) ; 上野 悟 国立保健医療科学院, その他部局等, 上席主任研究官 (20595706)
• Project Period (FY): 2017-04-01 – 2022-03-31
• Keywords: 効率化

Outline of Final Research Achievements

In this study, we created programs for data checking for clinical research data using the statistical analysis software R. We also constructed an efficient inquiry flow for data queries and built a report generation program using the R studio report generation function, which is R-related software. The data checking using R statistical analysis software and the report generation function of R studio was considered to be applicable and reusable for data management in other clinical trials. In those cases, it would be favorable to standardize the names of data items.

Free Research Field

臨床研究データ管理

Academic Significance and Societal Importance of the Research Achievements

臨床研究のデータマネジメントの手法が再利用されることで、コストも含めた効率的なデータマネジメントが可能になると考えられる。