| 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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| 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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