A study on the introduction of statistical quality control method in clinical trials related industries
Project/Area Number |
22700288
|
Research Category |
Grant-in-Aid for Young Scientists (B)
|
Allocation Type | Single-year Grants |
Research Field |
Statistical science
|
Research Institution | Hokkaido University |
Principal Investigator |
ITO Yoichi 北海道大学, 大学院・医学研究科, 准教授 (10334236)
|
Project Period (FY) |
2010 – 2012
|
Project Status |
Completed (Fiscal Year 2012)
|
Budget Amount *help |
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2012: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2011: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2010: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
|
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 |
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.
|
Report
(4 results)
Research Products
(5 results)