Glossary entry

Deutsch term or phrase:

Leiter einer klinischen Prüfung

Englisch translation:

Clinical Trial Director

Added to glossary by Ventnai
Sep 8, 2005 18:00
19 yrs ago
35 viewers *
Deutsch term

Leiter (einer klinischen Prüfung)

Deutsch > Englisch Medizin Medizin: Pharmazie Clinical trials
what would be the best way to translate "leiter" in this context ? head sounds too informal and vague

"dass für den aktuellen prüfplan ein positives votum der ethik-kommission des leiters der klinischen prüfung vorliegt"

Proposed translations

+1
9 Min.
Selected

Clinical Trial Director

Clinical Trial Director
Description: Top 10 Pharma Company is seeking a CLINICAL TRIAL DIRECTOR in Cambridge Massachusetts.
http://bioview.com/bv/servlet/BVJobDetails?JOB_ID=33173

Kathy Berra, MSN, ANP, Clinical Trial Director
http://www.fda.gov/ohrms/dockets/dockets/00n1256/lst0001.doc

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Note added at 1 hr 21 mins (2005-09-08 19:22:14 GMT)
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This might be helpful, too: www.dg-thoraxchirurgie.de/P-Luntz.ppt

Begriffsdefinition:

Prüfer, Prüfarzt (Subinvestigator)
führt die Studie im Zentrum praktisch durch (z.B. Ass.Arzt)

Hauptprüfer (Principal Investigator (PI))
Leiter einer Gruppe von mehreren Prüfern an einer Prüfstelle
nach außen verantwortlich für die Durchführung innerhalb seiner Abteilung (Oberarzt, ärztl. Direktor)

Leiter der Klinischen Prüfung (LKP)
ein Arzt verantwortlich für alle Zentren in Deutschland
mindestens 2 jährige Erfahrung in der Durchführung klinischer Prüfungen

Coordinating Investigator
i.d.R. ein Opinion Leader, der die Studie international vertritt
Peer comment(s):

agree MMUlr : Principal investigator//s. auch http://www.ak-med-ethik-komm.de/struktur_main.html (unter "Multizenterstudien")
13 Stunden
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4 KudoZ points awarded for this answer. Comment: "Thanks very much"
+3
7 Min.

Director

I'd say here

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Note added at 8 mins (2005-09-08 18:08:40 GMT)
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(of a clinical study)

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Note added at 9 mins (2005-09-08 18:09:52 GMT)
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Or: clinical review ... depends on what is at issue
Peer comment(s):

agree Bjørn Anthun : (didn't see your answer when I posted mine) // well, I used "clinical trial director" simply because Ian stated that this pertains to a clinical trial in his question details.
2 Min.
Thanks, Renate. I think trial is probably even better.//AH! I completely overlooked that! : /
agree jccantrell : more general, would go with this. My wife is Medical Director of a nursing home.
6 Min.
Thanks, JC
agree Edith Kelly
20 Min.
Thanks, Ms. Kelly
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13 Min.

director of clinical investigation

Another possibility:

“director of clinical investigation” Leiter der klinischen Prüfung (LKP)

http://www.americantranslators.org/divisions/GLD/docs/44_kon...
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+2
1 Stunde

not for points

This term is well defined in the European legislation
for example see:

There has been a change in some of the language used. A Chief Investigator is the lead investigator for a whole MS and signs the application. The term ‘Principal Investigator’ cannot be used as the Directive defines this as the person in charge of the trial at a local site.
http://www.acmedsci.ac.uk/forum_sum.pdf

Depending on context it is either:

Chief Investigator
or as Sven already suggested:
Principal Investigator
Peer comment(s):

agree MMUlr : Principal investigator - see http://www.mrc.ac.uk/pdf-ctg.pdf (page 16) or http://www.gesundheitspolitik.net/04_medikamente/zulassung/g...
11 Stunden
agree Anne-Carine Zimmer : chief investigator
3993 Tage
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