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investigator site file

Czech translation: soubor informací pro zkoušejícího

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase: investigator site file Czech translation: soubor informací pro zkoušejícího Entered by: marek tesina

08:46 Mar 20, 2015

English to Czech translations [PRO] Medical - Medical: Pharmaceuticals
English term or phrase: investigator site file The Investigator Site File contains all essential documents held by Principal Investigator(s) conducting a trial which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. Existuje ustálený český termín? Na stránkách SÚKL nemohu nic najít. Děkuji za pomoc.	marek tesina KudoZ activity Questions: 135 (10 open) (3 without valid answers) (1 closed without grading) Answers: 40 Czech Republic Local time: 15:59
soubor informací pro zkoušejícího Explanation: Podle mne je to jen jiný název pro Investigator's Brochure, která je upravena v legislativě, viz http://ec.europa.eu/health/files/eudralex/vol-10/2010_c82_01... http://ec.europa.eu/health/files/eudralex/vol-1/dir_2005_28/... -------------------------------------------------- Note added at 3 hrs (2015-03-20 11:49:11 GMT) -------------------------------------------------- Tak asi ne... podle tohoto je to složitější: http://www.sth.nhs.uk/clientfiles/File/sop_a116_investigator... pak asi něco jako "souhrnná dokumentace klinického hodnocení vedená zkoušejícím" ve smyslu §9 vyhlášky 226/2008 Sb. o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků -------------------------------------------------- Note added at 3 hrs (2015-03-20 11:50:03 GMT) -------------------------------------------------- to "souhrnná" tam nemusí být	Selected response from: Petr Kedzior Czech Republic Local time: 15:59
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3	soubor informací pro zkoušejícího	Petr Kedzior

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2 hrs   confidence:

soubor informací pro zkoušejícího Explanation: Podle mne je to jen jiný název pro Investigator's Brochure, která je upravena v legislativě, viz http://ec.europa.eu/health/files/eudralex/vol-10/2010_c82_01... http://ec.europa.eu/health/files/eudralex/vol-1/dir_2005_28/... -------------------------------------------------- Note added at 3 hrs (2015-03-20 11:49:11 GMT) -------------------------------------------------- Tak asi ne... podle tohoto je to složitější: http://www.sth.nhs.uk/clientfiles/File/sop_a116_investigator... pak asi něco jako "souhrnná dokumentace klinického hodnocení vedená zkoušejícím" ve smyslu §9 vyhlášky 226/2008 Sb. o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků -------------------------------------------------- Note added at 3 hrs (2015-03-20 11:50:03 GMT) -------------------------------------------------- to "souhrnná" tam nemusí být	Petr Kedzior Czech Republic Local time: 15:59 Specializes in field Native speaker of: Czech PRO pts in category: 11
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