natgillin/translations-raw huggingface dataset:
Informed consent may be obtained by the simplified means set out in paragraph 2, if all the following conditions are fulfilled:
Raziskovalec dokumentira vse zavrnitve in umike in zagotovi, da se za klinično preskušanje ne zbirajo podatki udeležencev, ki ne želijo sodelovati ali ki so se umaknili iz kliničnega preskušanja.
the simplified means for obtaining informed consent do not contradict national law in the Member State concerned;
Člen 31
the methodology of the clinical trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products in a clinical trial;
Klinična preskušanja na nezmožnih osebah
the clinical trial is a low-intervention clinical trial and the investigational medicinal products are used in accordance with the terms of the marketing authorisation;
V primeru, da nezmožna oseba ni dala prostovoljne privolitve po poučitvi ali tega ni zavrnila pred nastankom njene nezmožnosti, se lahko klinično preskušanje izvede samo, če so poleg pogojev iz člena 28 izpolnjeni vsi naslednji pogoji:
there are no interventions other than the standard treatment of the subjects concerned;
pridobljena je bila prostovoljna privolitev po poučitvi njihovega zakonito imenovanega zastopnika;
the protocol justifies the reasons for obtaining informed consent with simplified means and describes the scope of information provided to the subjects, as well as the ways of providing information.
nezmožne osebe so dobile informacije iz člena 29(2) na način, ki je primeren glede na njihove sposobnosti razumevanja;
The investigator shall document all refusals and withdrawals and shall ensure that no data for the clinical trial are collected from subjects that refuse to participate in or have withdrawn from the clinical trial.
raziskovalec spoštuje izrecno željo nezmožne osebe, ki je sposobna izražati mnenje in oceniti informacije iz člena 29(2), da zavrne sodelovanje v kliničnem preskušanju ali da se iz kliničnega preskušanja kadar koli umakne;
Article 31
udeleženci ali njihovi zakonito imenovani zastopniki niso deležni spodbud ali finančne podpore razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v kliničnem preskušanju;
Clinical trials on incapacitated subjects
klinično preskušanje je bistveno za ovrednotenje podatkov o nezmožnih osebah in se podatki primerljive veljavnosti ne morejo pridobiti v kliničnih preskušanjih na osebah, ki so sposobne dati prostovoljno privolitev po poučitvi, ali z drugimi raziskovalnimi metodami;
In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical trial may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met:
klinično preskušanje se neposredno nanaša na zdravstveno stanje udeleženca;
the informed consent of their legally designated representative has been obtained;
obstajajo znanstveni razlogi za pričakovanje, da bo sodelovanje v kliničnem preskušanju prineslo:
the incapacitated subjects have received the information referred to in Article 29(2) in a way that is adequate in view of their capacity to understand it;
neposredno korist za nezmožno osebo, ki bo odtehtala tveganja in bremena, ali
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
nekaj koristi za populacijo, ki jo zastopa zadevna nezmožna oseba, če je klinično preskušanje neposredno povezano s smrtno nevarnimi ali izčrpavajočimi zdravstvenimi stanji udeležencev in predstavlja minimalno nevarnost in breme za zadevno nezmožno osebo v primerjavi z običajnim zdravljenjem njenega zdravstvenega stanja.
no incentives or financial inducements are given to the subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial;
Točka (g)(ii) odstavka 1 ne posega v strožja nacionalna pravila, ki prepovedujejo izvajanje teh kliničnih preskušanj na nezmožnih osebah, če ni znanstveno utemeljeno pričakovati, da bo sodelovanje v kliničnem preskušanju prineslo neposredno korist, ki bo odtehtala tveganja in bremena.
the clinical trial is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical trials on persons able to give informed consent, or by other research methods;
Udeleženec v čim večji meri sodeluje pri postopku prostovoljne privolitve po poučitvi.
the clinical trial relates directly to a medical condition from which the subject suffers;
Člen 32
there are scientific grounds for expecting that participation in the clinical trial will produce:
Klinična preskušanja na mladoletnikih
a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
Klinično preskušanje na mladoletnikih se lahko izvaja le, kadar so poleg pogojev iz člena 28 izpolnjeni vsi naslednji pogoji:
some benefit for the population represented by the incapacitated subject concerned when the clinical trial relates directly to the life-threatening or debilitating medical condition from which the subject suffers and such trial will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject's condition.
mladoletniki so od raziskovalcev ali članov skupine, ki izvajajo preskušanje in so usposobljeni za delo z otroki ali imajo izkušnje na tem področju, prejeli informacije iz člena 29(2), prilagojene njihovi starosti in duševni zrelosti;
Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those clinical trials on incapacitated subjects, where there are no scientific grounds to expect that participation in the clinical trial will produce a direct benefit to the subject outweighing the risks and burdens involved.
raziskovalec spoštuje izrecno željo mladoletnika, ki je sposoben izražati mnenje in oceniti informacije iz člena 29(2), da zavrne sodelovanje v kliničnem preskušanju ali da se iz kliničnega preskušanja kadar koli umakne;
The subject shall as far as possible take part in the informed consent procedure.
udeleženci ali njihovi zakonito imenovani zastopniki ne dobijo nobene spodbude ali finančne podpore razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v kliničnem preskušanju;
Article 32
namen kliničnega preskušanja je raziskati načine zdravljenja zdravstvenega stanja, ki se pojavlja samo pri mladoletnikih ali pa je klinično preskušanje bistveno v povezavi z mladoletniki – za ovrednotenje podatkov o osebah, ki so sposobne dati prostovoljno privolitev po poučitvi, podatki pa so pridobljeni v kliničnih preskušanjih ali z drugimi raziskovalnimi metodami;
Clinical trials on minors
klinično preskušanje se neposredno nanaša na zdravstveno stanje zadevnega mladoletnika ali pa gre za klinično raziskavo, ki jo je mogoče izvajati samo na mladoletnikih;
A clinical trial on minors may be conducted only where, in addition to the conditions set out in Article 28, all of the following conditions are met:
neposredno korist za zadevnega mladoletnika, ki bo odtehtala tveganja in bremena, ali
the minors have received the information referred to in Article 29(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;
nekaj koristi za populacijo, ki jo predstavlja zadevni mladoletnik, in bo tako klinično preskušanje predstavljalo minimalno nevarnost in breme za zadevnega mladoletnika v primerjavi z običajnim zdravljenjem njegovega zdravstvenega stanja.
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 29(2) to refuse participation in, or to withdraw from, the clinical trial at any time, is respected by the investigator;
Mladoletnik je vključen v postopek prostovoljne privolitve po poučitvi na način, ki je prilagojen njegovi starosti in duševni zrelosti.
no incentives or financial inducements are given to the subject or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial;
Če med kliničnim preskušanjem mladoletnik postane polnoleten in lahko da prostovoljno privolitev po poučitvi v skladu z opredelitvijo v nacionalnem pravu zadevne države članice, se, preden ta udeleženec lahko nadaljuje svoje sodelovanje v kliničnem preskušanju, pridobi njegova izrecna prostovoljna privolitev po poučitvi.
the clinical trial is intended to investigate treatments for a medical condition that only occurs in minors or the clinical trial is essential with respect to minors to validate data obtained in clinical trials on persons able to give informed consent or by other research methods;
Člen 33
the clinical trial either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;
Klinična preskušanja na nosečnicah ali doječih materah
a direct benefit for the minor concerned outweighing the risks and burdens involved; or
Klinično preskušanje na nosečnicah ali doječih materah se lahko izvaja samo, kadar so poleg pogojev iz člena 28 izpolnjeni naslednji pogoji:
some benefit for the population represented by the minor concerned and such a clinical trial will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor's condition.
klinično preskušanje bi lahko prineslo neposredno korist za zadevno nosečnico ali doječo mater ali njen zarodek, plod ali novorojenca, ki bi odtehtala tveganja in bremena, ali
The minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity.
če klinično preskušanje nima neposrednih koristi za zadevno nosečnico ali doječo mater ali njen zarodek, plod ali novorojenca, se lahko izvaja samo, če:
If during a clinical trial the minor reaches the age of legal competence to give informed consent as defined in the law of the Member State concerned, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical trial.
se klinično preskušanje primerljive učinkovitosti ne more izvajati na ženskah, ki niso noseče oziroma ne dojijo;
Article 33
prispeva k doseganju rezultatov, ki bi lahko koristili nosečnicam ali doječim materam ali drugim ženskam v zvezi z oploditvijo ali drugim zarodkom, plodom ali otrokom, ter
Clinical trials on pregnant or breastfeeding women
klinično preskušanje pomeni minimalno tveganje in minimalno breme za zadevno nosečnico ali doječo mater, njen zarodek, plod ali novorojenca;
A clinical trial on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 28, the following conditions are met:
kadar se raziskava izvaja na doječih materah, je treba posebno pozornost nameniti preprečevanju vseh negativnih vplivov na otrokovo zdravje, in
the clinical trial has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; or
udeleženci niso deležni spodbud ali finančne podpore razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v kliničnem preskušanju.
if such clinical trial has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if:
Člen 34
a clinical trial of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding;
Dodatni nacionalni ukrepi
the clinical trial contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and
Države članice lahko ohranijo dodatne ukrepe za osebe, ki služijo obvezni vojaški rok, osebe, ki jim je bila odvzeta prostost, osebe, ki se zaradi sodne odločbe ne morejo udeležiti kliničnih preskušanj, ali osebe, ki so nastanjene v domovih.
the clinical trial poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;
Člen 35
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child; and
Klinična preskušanja v nujnih primerih
no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial.
Z odstopanjem od točk (b) in (c) člena 28(1), točk (a) in (b) člena 31(1) ter točk (a) in (b) člena 32(1) se lahko prostovoljna privolitev po poučitvi za sodelovanje v kliničnem preskušanju pridobi ter informacije o kliničnem preskušanju dajo, po odločitvi o vključitvi udeleženca v klinično preskušanje, pod pogojem, da se odločitev sprejme ob prvi intervenciji na udeležencu v skladu s protokolom za to klinično preskušanje, in če so izpolnjeni vsi naslednji pogoji:
Article 34
zaradi nujnosti zdravljenja zaradi nenadnega življenjsko nevarnega ali drugega nenadnega resnega zdravstvenega stanja od udeleženca predhodno ni mogoče pridobiti prostovoljne privolitve po poučitvi in mu tudi ni mogoče dati predhodnih informacij o kliničnem preskušanju;
Additional national measures
obstajajo znanstveni razlogi za pričakovanje, da bi lahko sodelovanje v kliničnem preskušanju prineslo neposredno relevantno klinično korist za udeleženca, ki bi lahko pripomogla k merljivemu zdravstvenemu izboljšanju, olajšala trpljenje in/ali izboljšala udeleženčevo zdravje ali diagnozo njegovega stanja;
Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, or persons in residential care institutions.
v obdobju zdravljenja ni mogoče dati vseh predhodnih informacij in pridobiti predhodne prostovoljne privolitve po poučitvi od njegovega zakonito imenovanega zastopnika;
Article 35
raziskovalec uradno potrdi, da ne ve za morebitno že izraženo udeleženčevo nasprotovanje sodelovanju v kliničnem preskušanju, ki bi ga udeleženec izrazil pred tem;
Clinical trials in emergency situations
klinično preskušanje neposredno zadeva udeleženčevo zdravstveno stanje, zaradi katerega v obdobju zdravljenja od njegovega zakonito imenovanega zastopnika ni mogoče pridobiti predhodne prostovoljne privolitve po poučitvi in mu zagotoviti predhodnih informacij, klinično preskušanje pa je takšne vrste, da se lahko izvaja izključno v nujnih primerih;
By way of derogation from points (b) and (c) of Article 28(1), from points (a) and (b) of Article 31(1) and from points (a) and (b) of Article 32(1), informed consent to participate in a clinical trial may be obtained, and information on the clinical trial may be given, after the decision to include the subject in the clinical trial, provided that this decision is taken at the time of the first intervention on the subject, in accordance with the protocol for that clinical trial" and that all of the following conditions are fulfilled:
klinično preskušanje pomeni minimalno tveganje in minimalno stopnjo invazivnosti za udeleženca v primerjavi z običajnim zdravljenjem njegovega stanja.
due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the clinical trial;
Po intervenciji iz odstavka 1 se skuša v skladu s členom 29 pridobiti prostovoljna privolitev po poučitvi, da se nadaljuje udeleženčevo sodelovanje v kliničnem preskušanju, informacije pa se dajo v skladu z naslednjimi zahtevami:
there are scientific grounds to expect that participation of the subject in the clinical trial 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;
prostovoljno privolitev po poučitvi pri nezmožnih osebah in mladoletnikih raziskovalec brez odlašanja pridobi od njihovih zakonito imenovanih zastopnikov, informacije iz člena 29(2) pa se čim prej dajo udeležencu in njegovemu zakonito imenovanemu zastopniku;
it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from his or her legally designated representative;
prostovoljno privolitev po poučitvi pri drugih udeležencih raziskovalec brez odlašanja pridobi od udeleženca ali njegovega zakonito imenovanega zastopnika, kar je prej, informacije iz člena 29(2) pa se čim prej dajo udeležencu ali njegovem zakonito imenovanemu zastopniku, kar je prej.
the investigator certifies that he or she is not aware of any objections to participate in the clinical trial previously expressed by the subject;
Kadar je bila prostovoljna privolitev po poučitvi pridobljena od zakonito imenovanega zastopnika, se za namene točke (b) zaradi nadaljevanja sodelovanja v kliničnem preskušanju prostovoljna privolitev udeleženca po poučitvi pridobi, ko je udeleženec sposoben dati prostovoljno privolitev po poučitvi.
the clinical trial 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 clinical trial is of such a nature that it may be conducted exclusively in emergency situations;
Če udeleženec ali, kadar je potrebno, njegov zakonito imenovani zastopnik ne da privolitve, se ga obvesti o pravici, da nasprotuje uporabi podatkov, pridobljenih pri kliničnem preskušanju.
the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
POGLAVJE VI
Following an intervention pursuant to paragraph 1, informed consent in accordance with Article 29 shall be sought to continue the participation of the subject in the clinical trial, and information on the clinical trial shall be given, in accordance with the following requirements:
ZAČETEK, KONEC, ZAČASNA USTAVITEV IN PREDČASNA USTAVITEV KLINIČNEGA PRESKUŠANJA
regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 29(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
Člen 36
regarding other subjects, the informed consent shall be sought by the investigator without undue delay from the subject or his or her legally designated representative, whichever is sooner and the information referred to in Article 29(2) shall be given as soon as possible to the the subject or his or her legally designated representative, whichever is sooner.
Obvestilo o začetku kliničnega preskušanja in končanem pridobivanju udeležencev
For the purposes of point (b), where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical trial shall be obtained from the subject as soon as he or she is capable of giving informed consent.
Sponzor prek portala EU obvesti vsako zadevno državo članico o začetku kliničnega preskušanja v navedeni državi članici.
If the subject or, where applicable, his or her legally designated representative does not give consent, he or she shall be informed of the right to object to the use of data obtained from the clinical trial.
Uradno obvestilo se pošlje v 15 dneh po začetku kliničnega preskušanja v navedeni državi članici.
CHAPTER VI
Sponzor prek portala EU obvesti vsako zadevno državo članico o prvem obisku prvega udeleženca v tej državi članici.
START, END, TEMPORARY HALT, AND EARLY TERMINATION OF A CLINICAL TRIAL
Obvestilo se pošlje v 15 dneh po prvem obisku prvega udeleženca v tej državi članici.
Article 36
Sponzor prek portala EU obvesti vsako zadevno državo članico o končanem pridobivanju udeležencev kliničnega preskušanja v navedeni državi članici.
Notification of the start of a clinical trial and of the end of the recruitment of subjects
Uradno obvestilo pošlje v 15 dneh po končanem pridobivanju udeležencev.
The sponsor shall notify each Member State concerned of the start of a clinical trial in relation to that Member State through the EU portal.
V primeru ponovnega pridobivanja udeležencev se uporablja odstavek 1.
That notification shall be made within 15 days from the start of the clinical trial in relation to that Member State.
Člen 37
The sponsor shall notify each Member State concerned of the first visit of the first subject in relation to that Member State through the EU portal.
Konec kliničnega preskušanja, začasna ustavitev in predčasna ustavitev kliničnega preskušanja ter predložitev rezultatov
That notification shall be made within 15 days from the first visit of the first subject in relation to that Member State.
Sponzor prek portala EU obvesti vsako zadevno državo članico o koncu kliničnega preskušanja v tej državi članici.
The sponsor shall notify each Member State concerned of the end of the recruitment of subjects for a clinical trial in that Member State through the EU portal.
Uradno obvestilo se pošlje v 15 dneh po koncu kliničnega preskušanja v tej državi članici.
That notification shall be made within 15 days from the end of the recruitment of subjects.
Sponzor prek portala EU obvesti vsako zadevno državo članico o koncu kliničnega preskušanja v vseh zadevnih državah članicah.
In case of re-start of recruitment, paragraph 1 shall apply.
Obvestilo se pošlje v 15 dneh po koncu kliničnega preskušanja v zadnji zadevni državi članici.
Article 37
Sponzor prek portala EU obvesti vsako zadevno državo članico o koncu kliničnega preskušanja v vseh zadevnih državah članicah in vseh tretjih državah, v katerih se je izvajalo klinično preskušanje.
End of a clinical trial, temporary halt and early termination of a clinical trial and submission of the results
To obvestilo se pošlje v 15 dneh po koncu kliničnega preskušanja v zadnji od zadevnih držav članic in tretjih držav, v katerih se je izvajalo klinično preskušanje.
The sponsor shall notify each Member State concerned of the end of a clinical trial in relation to that Member State through the EU portal.
Sponzor ne glede na rezultate kliničnega preskušanja v enem letu po koncu kliničnega preskušanja v vseh zadevnih državah članicah v podatkovno zbirko EU pošlje povzetek rezultatov kliničnega preskušanja.
That notification shall be made within 15 days from the end of the clinical trial in relation to that Member State.
Vsebina tega povzetka je določena v Prilogi IV.
The sponsor shall notify each Member State concerned of the end of a clinical trial in all Member States concerned through the EU portal.
Kadar pa iz znanstvenih razlogov, navedenih protokolu, v enem letu ni mogoče predložiti povzetka rezultatov, se predloži takoj, ko je na voljo.
That notification shall be made within 15 days from the end of the clinical trial in the last Member State concerned.
V tem primeru je v protokolu določeno, kdaj je treba predložiti rezultate, in je navedena utemeljitev.