Glossary entry

Dutch term or phrase:

wijziging

English translation:

amendment

Added to glossary by katerina turevich
Oct 19, 2014 21:44
9 yrs ago
2 viewers *
Dutch term

wijziging

Non-PRO Dutch to English Medical Surveying professional applications/paper work
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.
Proposed translations (English)
4 +2 amendment
Change log

Oct 20, 2014 08:35: Marie-Helene Dubois changed "Level" from "PRO" to "Non-PRO"

Votes to reclassify question as PRO/non-PRO:

Non-PRO (3): Edith Kelly, sindy cremer, Marie-Helene Dubois

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Discussion

Textpertise Oct 19, 2014:
Notification of amendment is fine They are amending the research protocol and advising the ethics committee of that fact. Feel free to use "Notification of amendment".

Proposed translations

+2
14 mins
Selected

amendment

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)
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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.
Note from 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 comment(s):

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.
Something went wrong...
4 KudoZ points awarded for this answer. Comment: "Thanks! "
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