Building a model for standardization and efficiency of data management in clinical research
| Project/Area Number |
16K21151
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Epidemiology and preventive medicine
Medical and hospital managemen
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| Research Institution | Osaka University |
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Principal Investigator |
Jingushi Kiwako 大阪大学, 医学部附属病院, 特任研究員 (70772820)
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| Project Period (FY) |
2016-04-01 – 2022-03-31
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| Project Status |
Completed (Fiscal Year 2021)
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| Budget Amount *help |
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2018: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2017: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
Fiscal Year 2016: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000)
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| Keywords | 臨床研究 / データマネジメント / 効率化 / CDISC / 標準化 |
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| Outline of Final Research Achievements |
In this study, we developed (1) a coding support tool, (2) an EDC-independent logical checking program, and (3) a protocol creation support tool. Development of the coding support tool and the EDC-independent logical checking program increased the efficiency of each operations and the output results were accurate. For a protocol creation support tool, the evaluation was not completed due to the revision of the research plan, and the tool was only developed during the period of this study. We will continue to evaluate this tool and report the results at academic conferences.
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| Academic Significance and Societal Importance of the Research Achievements |
データマネジメントやCDISCといった領域については、他の研究領域と比較しても、あまり学術的研究がなされていないのが現状である。本研究の成果においては十分とは言えない点もあるが、本研究がデータマネジメントやCDISCといった領域における学術的研究の促進につながるきっかけの一つになればと期待する。
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Report
(7 results)
Research Products
(1 results)
