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  3. Medical: Pharmaceuticals

beantragte nachträgliche Änderungen

English translation: subsequently submitted changes/revisions

10:48 Nov 17, 2014
German to English translations [PRO]
Medical - Medical: Pharmaceuticals / regulatory
German term or phrase: beantragte nachträgliche Änderungen
Die beantragten nachträglichen Änderungen koennen nicht genehmigt werde, Einwaende werden erhoben.

I know what it means, and of course I can produce a "free" translation, but since I have a minute to kill (a rare occurrence), I was wondering if there was a standard pharmaceutical regulatory formulation for the above expression, esp. "nachträglich" ( is there a single EN word for it? "Re-submitted" comes to mind)

Thanks for your input!
Lirka
Austria
Local time: 06:45
English translation:subsequently submitted changes/revisions
Explanation:
subsequent amending of the protocol, either as requested by an authority, or required to due to a change in the conduct of the trial
Selected response from:

Jonathan MacKerron
Grading comment
Thanks!
4 KudoZ points were awarded for this answer



Summary of answers provided
2 +3subsequently submitted changes/revisions
Jonathan MacKerron
4subsequent modifications that were requested
David Tracey, PhD
4retrospective/retroactive amendments which were applied for
Stephen Old
3post-hoc request for changes
Michael Martin, MA


Discussion entries: 2





  

Answers


11 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
subsequent modifications that were requested


Explanation:
"and any subsequent modifications will be reviewed and approved by the IRB or ethics committee responsible for ..."
https://actgnetwork.org/sites/default/files/members/.../Prot...

"... but it leaves uncertain whether this excludes subsequent modifications after the ....."
ethics.calbar.ca.gov/.../EthicsHotliner/Ethics_Hotliner-Fee_Modification_...

"...and any subsequent modifications will be reviewed and approved by the IRB or ethics committee responsible for ..."
research.ucdavis.edu/pgc/d/Scientific.doc/at_download/file

"Researchers submit all subsequent modifications to the protocol for ethics ..."
uwaterloo.ca/architecture/sites/.../_course_presentation2009arch-2_a.ppt

David Tracey, PhD
Local time: 06:45
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 76
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17 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): +3
subsequently submitted changes/revisions


Explanation:
subsequent amending of the protocol, either as requested by an authority, or required to due to a change in the conduct of the trial

Jonathan MacKerron
Specializes in field
Native speaker of: English
PRO pts in category: 180
Grading comment
Thanks!

Peer comments on this answer (and responses from the answerer)
agree  Celia Bodnar: or "subsequently submittted amendments"
1 hr
  -> yes, particularly now that Lirka has clarified the actual situation
agree  Ramey Rieger (X)
1 hr
agree  Harald Moelzer (medical-translator)
3 days 2 hrs
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2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
post-hoc request for changes


Explanation:
or less common, 'request for post-hoc changes'

It all depends how precise this needs to be. 'Subsequent' just means following a previous event while 'post hoc', in this context, means 'at a later time than it was supposed to have been done. See example below:

"The parties are advised, however, that the Court disfavors post hoc requests for extensions of time." http://www.gpo.gov/fdsys/pkg/USCOURTS-caed-1_09-cv-01743/pdf...

http://www.oxforddictionaries.com/us/definition/american_eng...


Michael Martin, MA
United States
Local time: 00:45
Native speaker of: Native in GermanGerman, Native in EnglishEnglish
PRO pts in category: 32
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22 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
retrospective/retroactive amendments which were applied for


Explanation:
I am pretty sure that I have come across nachträgliche Änderungen meaning retrospective/retroactive amendments/changes. Would that make sense here? There is at least one supporting translation like this in Linguee.de
http://www.linguee.de/deutsch-englisch?query=nachtr�gliche �nder...


Stephen Old
United Kingdom
Local time: 05:45
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 11
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