PERFORMANCE STUDY in Slovenian translation

• študija učinkovitosti
• študije učinkovitosti
• študiji učinkovitosti
• študijo učinkovitosti

Examples of using Performance study in English and their translations into Slovenian

A performance study on pregnant or breastfeeding women may be conducted only where,
Študija učinkovitosti na nosečnicah ali doječih materah se lahko izvaja samo, kadar so poleg pogojev iz člena 58(5)

any other person entitled by national law to provide the relevant patient care under performance study conditions;
sme v skladu z nacionalnim pravom ustrezno obravnavati paciente pod pogoji študije učinkovitosti;

The end of a performance study shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the performance study plan.
Šteje se, da zaključek študije učinkovitosti sovpada z zadnjim obiskom zadnjega udeleženca, razen če je v načrtu študije učinkovitosti določen zaključek ob drugem času.

of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Regulation
zahtevanih dodatnih informacij uradno obvesti, ali se šteje, da študija učinkovitosti spada v področje uporabe te uredbe

the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification;
brez vsakršnih škodljivih posledic in brez obrazložitve kadar koli umakne iz študije učinkovitosti;

it shall inform all Member States in which that performance study is being conducted thereof within 24 hours.
predčasno ustavi iz varnostnih razlogov, v 24 urah o tem obvesti vse države članice, v katerih se izvaja ta študija učinkovitosti.

The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the performance study is to be conducted acts as coordinating Member State.
Sponzor v enotni vlogi iz odstavka 1 predlaga, da ima ena od držav članic, v katerih bo potekala študija učinkovitosti, vlogo države članice koordinatorke.

If such a performance study has no direct benefit for the pregnant
Če taka študija učinkovitosti nima neposrednih koristi za zadevno nosečnico

The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 69,
Povzetek in poročilo o študiji učinkovitosti iz odstavka 5 tega člena postaneta prek elektronskega sistema iz člena 69 javno dostopna najpozneje takrat, ko je pripomoček registriran

which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study.
člena 69 za to študijo učinkovitosti ustvari enotno identifikacijsko številko, ki je edinstvena za celotno Unijo in se uporablja za vso komunikacijo v zvezi s to študijo učinkovitosti.

to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;
oceniti informacije iz člena 59(2), da zavrne sodelovanje v študiji učinkovitosti ali da se iz nje kadar koli umakne;

withdraw from the performance study at any time by revoking his or her informed consent.
brez obrazložitve kadar koli umakne iz študije učinkovitosti, tako da prekliče svojo privolitev po seznanitvi.

(i) the performance study has been designed to involve as little pain,
Študija učinkovitosti je zasnovana tako, da povzroča čim manj bolečine,

There are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering and/or improving the health of the subject, or in the diagnosis of its condition;
Na podlagi znanstvenih dokazov se upravičeno pričakuje, da bo sodelovanje udeleženca v študiji učinkovitosti prineslo neposredno klinično relevantno korist za udeleženca, ki bi zagotovila merljivo zdravstveno izboljšanje, olajšala trpljenje in/ali izboljšala udeleženčevo zdravje ali diagnozo njegovega stanja;

The performance study relates directly to the subject's medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations;
Študija učinkovitosti neposredno zadeva udeleženčevo zdravstveno stanje, zaradi katerega v okviru razpoložljivega časa za poseg od njegovega zakonito imenovanega zastopnika ni mogoče pridobiti predhodne privolitve po seznanitvi in mu zagotoviti predhodnih informacij, študija učinkovitosti pa je takšne vrste, da se lahko izvaja izključno v nujnih primerih;

other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I
razen pripomočkov za študijo učinkovitosti, se izvede ugotavljanje skladnosti, kot je določeno v poglavjih I

informed consent in accordance with Article 59 shall be sought to continue the participation of the subject in the performance study, and information on the performance study shall be given, in accordance with the following requirements.
tega člena se skuša v skladu s členom 59 pridobiti privolitev po seznanitvi, da se nadaljuje udeleženčevo sodelovanje v študiji učinkovitosti, informacije o študiji učinkovitosti pa se dajo v skladu z naslednjimi zahtevami.

other than devices for performance study, shall be subject to a conformity assessment as specified in Chapters I
razen pripomočkov za študijo učinkovitosti, se izvede ugotavljanje skladnosti, kot je določeno v poglavjih I

to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;
izrecno želi zavrniti sodelovanje v študiji učinkovitosti ali se iz nje kadar koli umakniti, raziskovalec to njegovo željo spoštuje;

other than devices for performance study, may, instead of the conformity assessment procedure applicable pursuant to paragraph 3,
razen pripomočkov za študijo učinkovitosti, lahko namesto postopka ugotavljanja skladnosti, ki se uporablja na podlagi odstavka 3,