Prüfgruppe

English translation: investigator's team/ investigator team

22:45 Jan 28, 2013
German to English translations [PRO]
Medical - Medical: Pharmaceuticals / clinical trials
German term or phrase: Prüfgruppe
Term comes up often in an Ethic Committee letter to a trial sponsor:
-In welcher Form haben der Prüfer und der/die Stellvertreter Kenntnisse über die neuen gesetzlichen Aufgaben und ihre Verantwortung für die *Prüfgruppe* erworben?
-Wie gewährleistet der Prüfer, dass alle Mitglieder der *Prüfgruppe ihre Pflichten und Aufgaben gemäß AMG, GCP-V, ICH-GCP kennen?
-Wie und wann erfolgt eine angemessene studienspezifische Einweisung und Unterrichtung der *Prüfgruppen-Mitglieder*? Wie werden sie in die studienspezifischen Unterlagen eingewiesen und auch im Verlauf der Prüfung angeleitet bzw. über Änderungen informiert? Wie werden neue Mitglieder eingewiesen und angeleitet?
-Wie erfolgen eine angemessene Überwachung der *Prüfgruppen-Mitglieder* und deren Arbeit durch den Prüfer?

Is this perhaps the "institutional review board" as defined in GCP?
TIA for your help!
Jonathan MacKerron
English translation:investigator's team/ investigator team
Explanation:

(investigator) team/ team members
S. 19 (bzw. 37/38)
http://www.forum-mdi.de/DVMD_2012/Chase.pdf

p.5
http://www.emea.europa.eu/docs/en_GB/document_library/Presen...
Selected response from:

Johanna Timm, PhD
Canada
Local time: 05:03
Grading comment
Thanks to all
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +4investigator's team/ investigator team
Johanna Timm, PhD
4Panel of examiners/investigators
Kalyani Gadre
4 -1Testing group/team
Salih YILDIRIM
3inspection team
Michael Martin, MA
2 -1test panel
gangels (X)


Discussion entries: 4





  

Answers


1 hr   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): -1
test panel


Explanation:
They are the guinea pigs. The Prüfer is in charge of them and checks out their behavior/reactions

gangels (X)
Local time: 06:03
Native speaker of: Native in EnglishEnglish, Native in GermanGerman
PRO pts in category: 52

Peer comments on this answer (and responses from the answerer)
disagree  Cetacea: Guinea pigs usually don't have any Pflichten or Aufgaben, nor are they ever eingewiesen and unterrichtet...
10 hrs
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2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +4
investigator's team/ investigator team


Explanation:

(investigator) team/ team members
S. 19 (bzw. 37/38)
http://www.forum-mdi.de/DVMD_2012/Chase.pdf

p.5
http://www.emea.europa.eu/docs/en_GB/document_library/Presen...


Johanna Timm, PhD
Canada
Local time: 05:03
Native speaker of: Native in GermanGerman
PRO pts in category: 121
Grading comment
Thanks to all
Notes to answerer
Asker: Thanks Johanna, see my discussion entry above.

Asker: Many thanks


Peer comments on this answer (and responses from the answerer)
agree  BrigitteHilgner: So verstehe ich das auch. http://ethikkommission.blaek.de/studien/amg-studien/antragsu...
6 hrs
  -> danke, Brigitte

agree  Susanne Schiewe
7 hrs
  -> danke, Susanne

agree  Cetacea
10 hrs
  -> Danke, cCtacea

agree  Harald Moelzer (medical-translator)
16 hrs
  -> Danke, Harald
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3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
Testing group/team


Explanation:
Imho

Salih YILDIRIM
United States
Local time: 08:03
Works in field
Native speaker of: Native in TurkishTurkish

Peer comments on this answer (and responses from the answerer)
disagree  Cetacea: Not in this specific medical context.
8 hrs
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4 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
inspection team


Explanation:
Example from link below:

"After receiving the dossier, the Lead Inspector allocated (from the MHRA GCP Inspectorate) contacts the organisation to agree the inspection date(s). A confirmation email is issued once the inspection dates are confirmed, which provides information on the inspection team and the logistical aspects of the inspection (for example, ensuring suitable office facilities and adequate resource are available)."


    Reference: http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionand...
Michael Martin, MA
United States
Local time: 08:03
Native speaker of: Native in GermanGerman, Native in EnglishEnglish
PRO pts in category: 32
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10 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
Panel of examiners/investigators


Explanation:
-

Kalyani Gadre
India
Local time: 17:33
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in MarathiMarathi
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