2012 Fiscal Year Final Research Report
A study on the introduction of statistical quality control method in clinical trials related industries
| Project/Area Number |
22700288
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Single-year Grants |
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| Research Field |
Statistical science
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| Research Institution | Hokkaido University |
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Principal Investigator |
ITO Yoichi 北海道大学, 大学院・医学研究科, 准教授 (10334236)
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| Project Period (FY) |
2010 – 2012
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| Keywords | 臨床試験 / データマネジメント / 統計的品質管理 / 教育プログラム開発 |
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| Research Abstract |
In this study, in order to perform efficient clinical trials, we aimed educational program development of statistical quality control methods in the clinical trials related industries. In certain pharmaceutical companies, a developed educational program has done. In order to confirm the operational improving effect by statistical quality control techniques, a research on the data management process from the last patient out to the database locked was carried out. As a result, the process may be reduced to about 20 days from about 40 days.
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