検証項目

English translation: validation item

17:57 Oct 18, 2020
Japanese to English translations [PRO]
Medical - Medical: Pharmaceuticals
Japanese term or phrase: 検証項目
Hi all, I have encountered this term in a document describing the results of a large study. The context is similar to this:

https://www.amel-di.com/medical/di/download?type=21&pid=1423...

In the document I am translating, 検証項目 is written in parentheses after both the primary endpoint and some, but not all of the secondary endpoints.

Could this indicate the "confirmatory" endpoints? (As opposed to "exploratory")

Thank you in advance!
Luca Balestra
United Kingdom
Local time: 18:22
English translation:validation item
Explanation:
I think the item with(検証項目) in the endpoint means that the item is also an item that requires validation tests, which are test items testing possibly other than safety and efficacy.

https://www.fda.gov/files/drugs/published/Analytical-Procedu...
Selected response from:

Reiko Ando
United States
Local time: 10:22
Grading comment
Thanks, I went with this :)
4 KudoZ points were awarded for this answer



Summary of answers provided
3validation item
Reiko Ando
Summary of reference entries provided
FYR
cinefil

Discussion entries: 2





  

Answers


4 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
validation item


Explanation:
I think the item with(検証項目) in the endpoint means that the item is also an item that requires validation tests, which are test items testing possibly other than safety and efficacy.

https://www.fda.gov/files/drugs/published/Analytical-Procedu...


Reiko Ando
United States
Local time: 10:22
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 4
Grading comment
Thanks, I went with this :)
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Reference comments


4 hrs
Reference: FYR

Reference information:
https://www.clinicaltrials.jp/cti-user/trial/ShowDirect.jsp?...

https://chikennavi.net/yougo/word/k/kenshouteki-shiken.htm

cinefil
Japan
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 66
Note to reference poster
Asker: Thanks for these, helpful as always!

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