Conduct of Research
Toward Public Health & Safe Society
SEND
SEND
SEND stands for Standard for Exchange of Nonclinical Data, developed and managed by CDISC. SEND Dataset is composed of Domain file, Define.XML, nSDRG(Nonclinical Study Data Reviewer’s Guide.
History of KIT SEND
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2015
Built SAVANTE and started first validation mapping
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2016
Completed SAVANTE system open validation and first mapping
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2017
First conversion from overseas test and completed second mapping
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2018
First conversion from domestic test and upgraded the system
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2019
Arranged professionals for SEND(Test manager, QA manager)
KIT SEND Program
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Data Collection Program
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Data Conversion Program
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Data Validation Program
KIT SEND Performance
| Year | GLP | Non-GLP |
|---|---|---|
| 2017 | 1 | - |
| 2018 | 5 | 1 |
| 2019 | 9 | 5 |
| 2020 | 12 | 10 |
- Conference presentation and hosted workshop about SEND
- Oct 25, 2018 Presented on the 34th on the Korean Society Nonclinical Study
- May 30, 2019 Hosted a workshop on 'Counterstrategy of Domestic Nonclinical Institution in Accordance with the Introduction to US FDA SEND'
- Oct 25 2019 Presented on the 36th on the Korean Society Nonclinical Study
- Nov 7, 2019 Presented on the ‘19 CDISC KOREA SUMMIT
- May 1, 2020 Chose a SEND relevant assignment from Ministry of Food, Drug and Safety