non interventional studies

Serbo-Croat translation: neintervencijske studije / ispitivanja

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:non interventional studies
Serbo-Croat translation:neintervencijske studije / ispitivanja
Entered by: Kristina Kolic

11:41 Jul 15, 2008
English to Serbo-Croat translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: non interventional studies
Template contract for non interventional studies
The Sponsor intends to perform (type of opservational study) entitled (to be completed) having the purpose to (enter Study description) i described in detail in the protocol.
Bogdan Petrovic
Serbia
Local time: 10:57
neintervencijske studije / ispitivanja
Explanation:
"Clinical trials are closely supervised by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial. The local ethics committee has discretion on how it will supervise noninterventional studies (observational studies or those using already collected data)."
http://en.wikipedia.org/wiki/Clinical_trial

"U Pravilniku se studije definiraju kao neintervencijska ispitivanja koja moraju imati odobrenje Središnjeg etičkog povjerenstva (SEP) temeljem dokumentacije koju prilaže proizvođač lijeka, u kojoj se među ostalim mora nalaziti plan ispitivanja, informirani pristanak za bolesnika, financijski plan ispitivanja te potvrda o uplati troškova postupka prijave ispitivanja. U Pravilniku se također navodi da se ispitivanje neće odobriti ako se utvrdi da potiče propisivanje lijekova. Prema podacima SEP-a, od donošenja Pravilnika ukupno je zaprimljeno dvanaest zahtjeva za davanje mišljenja o prihvatljivosti neintervencijskog ispitivanja."
http://www.poslovni.hr/84561.aspx

"Postmarketinško neintervencijsko kliničko ispitivanje leka (farmakoepidemiološko ispitivanje) jest ispitivanje u kome se lek primenjuje u skladu sa uslovima navedenim u dozvoli za stavljanje leka u promet ..."
http://www.alims.sr.gov.yu/download/regulativa/Pravilnici/Pr...

"za davanje mišljenja u postupku davanja odobrenja za neintervencijsko ispitivanje"
http://www.almp.hr/?ln=hr&w=o_SEPu
Selected response from:

Kristina Kolic
Croatia
Local time: 10:57
Grading comment
Hvala!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1neintervencijske studije / ispitivanja
Kristina Kolic


  

Answers


25 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
neintervencijske studije / ispitivanja


Explanation:
"Clinical trials are closely supervised by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before permission is granted to run the trial. The local ethics committee has discretion on how it will supervise noninterventional studies (observational studies or those using already collected data)."
http://en.wikipedia.org/wiki/Clinical_trial

"U Pravilniku se studije definiraju kao neintervencijska ispitivanja koja moraju imati odobrenje Središnjeg etičkog povjerenstva (SEP) temeljem dokumentacije koju prilaže proizvođač lijeka, u kojoj se među ostalim mora nalaziti plan ispitivanja, informirani pristanak za bolesnika, financijski plan ispitivanja te potvrda o uplati troškova postupka prijave ispitivanja. U Pravilniku se također navodi da se ispitivanje neće odobriti ako se utvrdi da potiče propisivanje lijekova. Prema podacima SEP-a, od donošenja Pravilnika ukupno je zaprimljeno dvanaest zahtjeva za davanje mišljenja o prihvatljivosti neintervencijskog ispitivanja."
http://www.poslovni.hr/84561.aspx

"Postmarketinško neintervencijsko kliničko ispitivanje leka (farmakoepidemiološko ispitivanje) jest ispitivanje u kome se lek primenjuje u skladu sa uslovima navedenim u dozvoli za stavljanje leka u promet ..."
http://www.alims.sr.gov.yu/download/regulativa/Pravilnici/Pr...

"za davanje mišljenja u postupku davanja odobrenja za neintervencijsko ispitivanje"
http://www.almp.hr/?ln=hr&w=o_SEPu

Kristina Kolic
Croatia
Local time: 10:57
Works in field
Native speaker of: Native in CroatianCroatian
PRO pts in category: 8
Grading comment
Hvala!

Peer comments on this answer (and responses from the answerer)
agree  Larisa Djuvelek-Ruggiero (X)
6 days
  -> Hvala!
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