Administrative Letter

Japanese translation: 治験計画変更通知書/届け

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Administrative Letter
Japanese translation:治験計画変更通知書/届け
Entered by: sasuke

00:51 Feb 18, 2014
English to Japanese translations [PRO]
Medical - Medical (general)
English term or phrase: Administrative Letter
Were updates to the Protocol, Amendment(s), and Administrative Letter(s) discussed with site personnel, if applicable? If Yes, provide comment. If No, open an issue.

Protocol とAdministrative letterはどちらも「治験実施計画書」と訳されてるようですが、違いは何でしょうか?
sasuke
Local time: 21:18
治験計画変更通知書/届け
Explanation:
http://www.tkgh.jp/uploads/img/sections/12chiken/86chikenkai...
Selected response from:

cinefil
Japan
Local time: 21:18
Grading comment
丁寧な説明もいただきありがとうございました。
4 KudoZ points were awarded for this answer



Summary of answers provided
1治験計画変更通知書/届け
cinefil
Summary of reference entries provided
FYI
cinefil
FYR
ganbajpn

  

Answers


42 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5
administrative letter
治験計画変更通知書/届け


Explanation:
http://www.tkgh.jp/uploads/img/sections/12chiken/86chikenkai...

cinefil
Japan
Local time: 21:18
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 324
Grading comment
丁寧な説明もいただきありがとうございました。
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Reference comments


40 mins peer agreement (net): +2
Reference: FYI

Reference information:
https://firstclinical.com/fda-gcp/?show=2008/RE Protocol ame...

http://www.quorumreview.com/sponsorscros/study/

cinefil
Japan
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 324

Peer comments on this reference comment (and responses from the reference poster)
agree  Kayoko Kimura: I agree.
10 hrs
agree  Chrisso (X)
4 days
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8 hrs
Reference: FYR

Reference information:
protocolはclinical protocolでよく出てくるように治験プロトコルや治験実施計画書で
http://www.tri-kobe.org/support/download/protocol_summary2.p...

Administrative Letterは
administrationが治験の分野においては管理のとか行政上のとかいう意味以外に投与という意味もありましたが、
http://www.hicareer.jp/trans/chiken/832.html
http://www.geocities.jp/medicaltranspump/medwaeikihon.txt

https://firstclinical.com/fda-gcp/?show=2008/RE Protocol ame...
やもう一つの答えのように治験実施計画書に追加して修正等を知らせるletterという意味合いではないでしょうか?

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Note added at 8 hrs (2014-02-18 09:35:03 GMT)
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おおざっぱな訳ですが、「治験プロトコル、プロトコルに対する修正、その修正を知らせる Administrative Letter」ということではないでしょうか?


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Note added at 9 hrs (2014-02-18 10:05:32 GMT)
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Administrative Letterは行政からの報告書とか・・・
行政文書( Administrative. Document)
承認通知書(Approval Letter)
http://www.info.pmda.go.jp/shinyaku/P201100133/53035900_2230...
より

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Note added at 9 hrs (2014-02-18 10:08:01 GMT)
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行政からの通知書ですね・・・。エラーが多くすみません。

ganbajpn
Japan
Works in field
Native speaker of: Native in JapaneseJapanese
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