Applying International Medical Information Standards for New Drug Submission Formats
| Project/Area Number |
24590603
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical sociology
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| Research Institution | The University of Tokyo |
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Principal Investigator |
KOIDE Daisuke 東京大学, 医学部附属病院, 特任准教授 (50313143)
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| Project Period (FY) |
2012-04-01 – 2015-03-31
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| Project Status |
Completed (Fiscal Year 2014)
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| Budget Amount *help |
¥2,990,000 (Direct Cost: ¥2,300,000、Indirect Cost: ¥690,000)
Fiscal Year 2014: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2012: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
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| Keywords | e-CTD / RPS / ICH / HL7 / CDISC |
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| Outline of Final Research Achievements |
The electronic version of Common Technical Document (e-CTD) has been approved for new drug submission in ICH. However, the new major version of e-CTD is now under development as Regulated Product Submission by not only ICH but other international standard organizations, such as Health Level Seven (HL7) and Clinical Data Interchange Standard Consortium (CDISC).
In order to make it better standard, this study has been conducted for comparing the technical requirements for the current e-CTD with the next version of e-CTD which is “RPS” and evaluate the social effect of it.
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Report
(4 results)
Research Products
(8 results)
