wijziging

English translation: amendment

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Dutch term or phrase:wijziging
English translation:amendment
Entered by: katerina turevich

21:44 Oct 19, 2014
Dutch to English translations [Non-PRO]
Medical - Surveying / professional applications/paper work
Dutch term or phrase: wijziging
EudraCT aanvraagformulierr d.d. XXX
EudraCT- formulier kennisgeving wijziging d.d. XXX
protocol versie amendement 1 dated XXX

does the word wijziging here refer to the adapted/modified application/notification form, or the changes in the submitted information?
This a very long list of documents submitted for research approval.
the third line doesn't really belong to EudraCT-: it is consecutive, it appears right after, but I included it here only to show that the formulier kennisgeving wijziging is not an amendment (!).

I found "Notification of Amendment" here http://www.vcmo.nl/wp-content/uploads/2014/06/PO-02-Beoordel... referring to the same document, I think. Should I just use ths? It doesn't really sound very convincing.
katerina turevich
Netherlands
Local time: 12:04
amendment
Explanation:
EudraCT- formulier kennisgeving wijziging d.d. XXX

EudraCT Notification of Amendment Form (B5)

You can see the Dutch ans English names of the forms here:

http://www.ccmo.nl/en/changes-to-the-research-file-amendment...

http://www.ccmo.nl/nl/wijzigingen-onderzoeksdossier-amendeme...

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Note added at 23 mins (2014-10-19 22:07:24 GMT)
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Example:

Temporary halt of a trial
When a sponsor halts a trial temporarily, he should notify the MHRA and Ethics Committees immediately and at least within 15 days from when the trial is temporarily halted. The notification should be made as a substantial amendment using the notification of amendment form available on the EudraCT: European Clinical Trials (external link) and clearly explain what has been halted (eg stopping recruitment and/or interrupting treatment of subjects already included) and the reasons for the temporary halt.

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofme...

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Note added at 46 mins (2014-10-19 22:31:04 GMT)
--------------------------------------------------

Perhaps I could say something helpful about this if we were sitting right next to each other. :-)

I can't see what you can see.
Selected response from:

Barend van Zadelhoff
Netherlands
Local time: 12:04
Grading comment
Thanks!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2amendment
Barend van Zadelhoff


Discussion entries: 1





  

Answers


14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
amendment


Explanation:
EudraCT- formulier kennisgeving wijziging d.d. XXX

EudraCT Notification of Amendment Form (B5)

You can see the Dutch ans English names of the forms here:

http://www.ccmo.nl/en/changes-to-the-research-file-amendment...

http://www.ccmo.nl/nl/wijzigingen-onderzoeksdossier-amendeme...

--------------------------------------------------
Note added at 23 mins (2014-10-19 22:07:24 GMT)
--------------------------------------------------

Example:

Temporary halt of a trial
When a sponsor halts a trial temporarily, he should notify the MHRA and Ethics Committees immediately and at least within 15 days from when the trial is temporarily halted. The notification should be made as a substantial amendment using the notification of amendment form available on the EudraCT: European Clinical Trials (external link) and clearly explain what has been halted (eg stopping recruitment and/or interrupting treatment of subjects already included) and the reasons for the temporary halt.

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofme...

--------------------------------------------------
Note added at 46 mins (2014-10-19 22:31:04 GMT)
--------------------------------------------------

Perhaps I could say something helpful about this if we were sitting right next to each other. :-)

I can't see what you can see.

Barend van Zadelhoff
Netherlands
Local time: 12:04
Native speaker of: Native in DutchDutch
Grading comment
Thanks!
Notes to answerer
Asker: Ok, thanks, sounds convincing. But isn't it strange that it appears once in the original of this very long list, and it will appear twice in its translation, originating from two different Dutch words, and then on top of it, right next to each other?


Peer comments on this answer (and responses from the answerer)
agree  Tina Vonhof (X): (Notification of) amendment is fine in both cases. Wijziging equals amendment, no reason to use two different words.
4 hrs
  -> Ah, now I see what Katarina's dilemma is. You have read her story more carefully than I did. Yes, an 'amendement' is a kind of 'wijziging'. A matter of context. Thank you for agreeing for that matter, Tina. Good evening (08:31).

agree  Edith Kelly
6 hrs
  -> Thank you, Edith.
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