Results for investigator's brochure translation from English to Slovenian

investigator's brochure
brošura za raziskovalca

investigator’s brochure
broŠura za raziskovalca

the investigator's brochure,
brošuro raziskovalca,

investigator’s brochure (ib)
brošura za raziskovalca

(d) the completeness and adequateness of the investigator’s brochure.
(d) popolnost in primernost brošure za raziskovalca.

the sponsor shall provide the investigator with the investigator’s brochure.
sponzor raziskovalcu predloži brošuro za raziskovalca.

the first subparagraph shall apply also to any update of the investigator’s brochure.
prvi pododstavek se uporablja tudi pri kakršnih koli posodobitvah brošure za raziskovalca.

the investigator’s brochure shall be validated and updated by the sponsor at least once a year.
brošuro za raziskovalca naročnik vsaj enkrat letno potrdi in posodobi.

the rsi is contained in the summary of product characteristics (‘smpc’) or the investigator's brochure (ib).
referenčne informacije o varnosti so navedene v povzetku glavnih značilnosti zdravila ali v brošuri za raziskovalca.

the investigator’s brochure shall be updated where new safety information becomes available, and at least once per year.
brošura za raziskovalca se dopolni, če so na voljo nove informacije o varnosti, in vsaj enkrat letno.

if the investigational medicinal product has a marketing authorisation, the summary of product characteristics may be used instead of the investigator’s brochure.
Če ima zdravilo v preskušanju dovoljenje za promet, se lahko namesto brošure za raziskovalca uporabi povzetek značilnosti izdelka.

the investigator’s brochure shall contain all clinical and non-clinical data on the investigational medicinal products relevant to the clinical trial.
brošura za raziskovalca vsebuje vse klinične in neklinične podatke o zdravilih v preskušanju, ki so pomembni za klinično preskušanje.

in order to ensure compliance of the conduct of the clinical trial with the protocol, and in order for investigators to be informed about the investigational medicinal products they administer, the sponsor should supply the investigators with an investigator’s brochure.
zaradi zagotavljanja skladnosti izvajanja kliničnega preskušanja s protokolom in zaradi obveščanja raziskovalcev o danih zdravilih v preskušanju bi moral sponzor raziskovalcem zagotoviti brošuro za raziskovalca.

the information in the investigator’s brochure, referred to in article 2(g) of directive 2001/20/ec, shall be presented in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial.
informacije v brošuri za raziskovalca iz člena 2(g) direktive 2001/20/es so predstavljene v jasni, preprosti, objektivni, uravnoteženi in nepromocijski obliki, ki omogoča, da jih klinični zdravnik ali morebitni raziskovalec razume in da lahko nepristransko oceni koristi in tveganja primernosti predlaganega kliničnega preskušanja.