Investigator Site File (ISF)

German translation: Investigator Site File (ISF)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Investigator Site File (ISF)
German translation:Investigator Site File (ISF)
Entered by: Edith Kelly

13:33 Nov 23, 2014
English to German translations [PRO]
Medical - Medical: Pharmaceuticals / Clinical Trial Agreement
English term or phrase: Investigator Site File (ISF)
An ISF is an Investigator Site File. This file is provided to the site (along with a Pharmacy Site File, if applicable) at the Site Initiation Visit. It contains all the information site staff will need to carry out the clinical trial at the site.
Esther Pugh
United States
Local time: 21:50
Investigator Site FIL (ISF)
Explanation:
das bleibt stehen im Deutschen

GCP- und GVP-Inspektionen - Swissmedic -
https://www.swissmedic.ch/bewilligungen/00155/00242/.../inde...
Bei Systeminspektionen beinhaltet dies unter anderem das Trial Master File (TMF) ... in Prüfzentren das Investigator Site File (ISF), die Patientenakten, die CRFs ...
[PDF]GCP-gerechte Archivierung - CenTrial GmbH
www.centrial.de/fileadmin/.../DZKF_Archivierung_komplette_V...
02.12.2010 - Deutschland, wie es Rechtsanwältin A. Neikes darstellte .... dem Prüfzentren (Investigator Site File,. ISF) aufzubewahren sind, besteht und bei.

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Note added at 16 mins (2014-11-23 13:49:14 GMT)
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Sorry .... "File" und nicht wie oben geschrieben.
Selected response from:

Edith Kelly
Switzerland
Local time: 03:50
Grading comment
Danke.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +6Investigator Site FIL (ISF)
Edith Kelly


  

Answers


15 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +6
investigator site file (isf)
Investigator Site FIL (ISF)


Explanation:
das bleibt stehen im Deutschen

GCP- und GVP-Inspektionen - Swissmedic -
https://www.swissmedic.ch/bewilligungen/00155/00242/.../inde...
Bei Systeminspektionen beinhaltet dies unter anderem das Trial Master File (TMF) ... in Prüfzentren das Investigator Site File (ISF), die Patientenakten, die CRFs ...
[PDF]GCP-gerechte Archivierung - CenTrial GmbH
www.centrial.de/fileadmin/.../DZKF_Archivierung_komplette_V...
02.12.2010 - Deutschland, wie es Rechtsanwältin A. Neikes darstellte .... dem Prüfzentren (Investigator Site File,. ISF) aufzubewahren sind, besteht und bei.

--------------------------------------------------
Note added at 16 mins (2014-11-23 13:49:14 GMT)
--------------------------------------------------

Sorry .... "File" und nicht wie oben geschrieben.

Edith Kelly
Switzerland
Local time: 03:50
Specializes in field
Native speaker of: Native in GermanGerman, Native in EnglishEnglish
PRO pts in category: 22
Grading comment
Danke.

Peer comments on this answer (and responses from the answerer)
agree  uyuni
30 mins

agree  Angelika Rank
2 hrs

agree  Steffen Walter: http://www.dmi.de/wissen/glossar/#c295 / Die deutsche Entsprechung wäre "Prüfarztordner", der englische Begriff hat sich jedoch durchgesetzt.
4 hrs

agree  Anne Schulz
5 hrs

agree  Susanne Schiewe
19 hrs

agree  MMUlr: Eher lt. Steffen "Prüfarztordner"
3 days 18 hrs
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