natgillin/translations-raw huggingface dataset:
This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a clinical investigation.
obstajajo znanstveni razlogi za pričakovanje, da bo mladoletni osebi udeležba v klinični raziskavi prinesla neposredno korist, ki bo odtehtala z udeležbo povezana tveganja in bremena.
Article 64
mladoletna oseba je v postopek privolitve po seznanitvi vključena tako, kot je ustrezno za njeno starost in duševno zrelost;
Clinical investigations on incapacitated subjects
če postane mladoletna oseba med klinično raziskavo polnoletna, tj. lahko da privolitev po seznanitvi, kot je opredeljeno v nacionalnem pravu, je treba pridobiti njeno izrecno privolitev po seznanitvi, sicer ne more več sodelovati v klinični raziskavi.
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 investigation may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
Člen 66
the informed consent of their legally designated representative has been obtained;
Klinične raziskave na nosečnicah ali doječih materah
the incapacitated subjects have received the information referred to in Article 63(2) in a way that is adequate in view of their capacity to understand it;
Klinična raziskava na nosečnicah ali doječih materah se lahko izvaja samo, kadar so poleg pogojev iz člena 62(4) izpolnjeni vsi naslednji pogoji:
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;
klinična raziskava bi lahko za zadevno nosečnico ali doječo mater ali njen zarodek, plod ali novorojenca prinesla neposredno korist, ki bi odtehtala z udeležbo v raziskavi povezana tveganja in bremena;
no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;
kadar se raziskava izvaja na doječih materah, je zlasti treba paziti, da se preprečijo vsakršni neželeni vplivi na otrokovo zdravje;
the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;
udeleženci niso deležni nobene spodbude ali finančne podpore, razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v klinični raziskavi.
the clinical investigation relates directly to a medical condition from which the subject suffers;
Člen 67
there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.
Dodatni nacionalni ukrepi
The subject shall as far as possible take part in the informed consent procedure.
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 raziskav, ali osebe, ki so nastanjene v domovih.
Article 65
Člen 68
Clinical investigations on minors
Klinične raziskave v nujnih primerih
A clinical investigation on minors may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
Z odstopanjem od točke (f) člena 62(4), točk (a) in (b) člena 64(1) ter točk (a) in (b) člena 65 se lahko privolitev po seznanitvi za sodelovanje v klinični raziskavi pridobi, informacije o klinični raziskavi pa dajo, potem ko je bila sprejeta odločitev o vključitvi udeleženca v klinično raziskavo, pod pogojem, da se ta odločitev sprejme ob prvem posegu na udeležencu v skladu z načrtom klinične raziskave za to klinično raziskavo in da so izpolnjeni vsi naslednji pogoji:
the minors have received the information referred to in Article 63(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;
zaradi nujnosti, ki izhaja iz nenadnega življenjsko nevarnega ali drugega nenadnega resnega zdravstvenega stanja, udeleženec ne more dati predhodne privolitve po seznanitvi in prejeti predhodnih informacij o klinični raziskavi;
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;
obstajajo znanstveni razlogi za pričakovanje, da bo udeležencu njegovo sodelovanje v klinični raziskavi morda prineslo neposredno klinično relevantno korist, katere posledica bo izmerljivo zdravstveno izboljšanje, s tem pa olajšanje trpljenja in/ali izboljšanje udeleženčevega zdravja, ali diagnoza njegovega stanja;
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 investigation;
v okviru razpoložljivega časa za poseg udeleženčevemu zakonito imenovanemu zastopniku ni mogoče dati vseh predhodnih informacij in od njega pridobiti predhodne privolitve po seznanitvi;
the clinical investigation is intended to investigate treatments for a medical condition that only occurs in minors or the clinical investigation is essential with respect to minors to validate data obtained in clinical investigations on persons able to give informed consent or by other research methods;
raziskovalec uradno potrdi, da ne ve za nobeno predhodno izraženo udeleženčevo nasprotovanje sodelovanju v klinični raziskavi;
the clinical investigation 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 raziskava neposredno zadeva udeleženčevo zdravstveno stanje, zaradi katerega v okviru razpoložljivega časa za poseg od njega ali njegovega zakonito imenovanega zastopnika ni mogoče pridobiti predhodne privolitve po seznanitvi in zagotoviti predhodnih informacij, klinična raziskava pa je takšne narave, da se lahko izvaja izključno v nujnih primerih;
there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the minor subject outweighing the risks and burdens involved;
klinična raziskava pomeni za udeleženca v primerjavi z običajnim zdravljenjem njegovega stanja minimalno tveganje in minimalno breme.
the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;
Po posegu na podlagi odstavka 1 tega člena se za nadaljevanje udeleženčevega sodelovanja v klinični raziskavi skuša pridobiti privolitev po seznanitvi iz člena 63 in se zagotovijo informacije o klinični raziskavi, pri čemer se upoštevajo naslednje zahteve:
if during a clinical investigation the minor reaches the age of legal competence to give informed consent as defined in national law, his or her express informed consent shall be obtained before that subject can continue to participate in the clinical investigation.
za udeležence, ki niso sposobni odločati o sebi, in mladoletne osebe skuša raziskovalec privolitev po seznanitvi pridobiti od njihovih zakonito imenovanih zastopnikov, in sicer brez odlašanja, informacije iz člena 63(2) pa se udeležencu in njegovemu zakonito imenovanemu zastopniku dajo čim prej;
Article 66
za druge udeležence skuša raziskovalec privolitev po seznanitvi brez odlašanja pridobiti od udeleženca ali od njegovega zakonito imenovanega zastopnika, kar je mogoče prej, informacije iz člena 63(2) pa se, čim je mogoče, dajo udeležencu oziroma njegovem zakonito imenovanemu zastopniku.
Clinical investigations on pregnant or breastfeeding women
Kadar je bila privolitev po seznanitvi pridobljena od zakonito imenovanega zastopnika, se za namene točke (b) zaradi nadaljevanja sodelovanja v klinični raziskavi privolitev po seznanitvi od udeleženca pridobi takoj, ko jo je ta sposoben dati.
A clinical investigation on pregnant or breastfeeding women may be conducted only where, in addition to the conditions set out in Article 62(4), all of the following conditions are met:
Če udeleženec ali po potrebi njegov zakonito imenovani zastopnik ne da privolitve, je obveščen, da ima pravico nasprotovati uporabi podatkov, pridobljenih v klinični raziskavi.
the clinical investigation 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;
Člen 69
where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;
Odškodnina za škodo
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 investigation.
Države članice zagotovijo, da so za morebitno škodo, ki jo udeleženec utrpi zaradi sodelovanja v klinični raziskavi, ki se izvaja na njihovem ozemlju, na voljo odškodninski sistemi v obliki zavarovanja, jamstva ali podobne ureditve, ki je glede namena enakovredna ter ustreza naravi in obsegu tveganja.
Article 67
Sponzor in raziskovalec uporabljata sistem iz odstavka 1 v obliki, ki je ustrezna za državo članico, v kateri se izvaja klinična raziskava.
Additional national measures
Člen 70
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 investigations, or persons in residential care institutions.
Vloga za klinične raziskave
Article 68
Sponzor klinične raziskave vlogo vloži v državi članici ali državah članicah, v katerih se bo klinična raziskava izvajala (v tem členu imenovana „zadevna država članica“), ter priloži dokumentacijo iz poglavja II Priloge XV.
Clinical investigations in emergency situations
Vloga se vloži prek elektronskega sistema iz člena 73, ki za klinično raziskavo ustvari enotno identifikacijsko številko, ki je edinstvena za celotno Unijo in se uporablja za vso komunikacijo v zvezi s to klinično raziskavo.
By way of derogation from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a clinical investigation may be obtained, and information on the clinical investigation may be given, after the decision to include the subject in the clinical investigation, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical investigation plan for that clinical investigation and that all of the following conditions are fulfilled:
Zadevna država članica v desetih dneh po prejemu dosjeja vloge uradno obvesti sponzorja, ali klinična raziskava spada v področje uporabe te uredbe in ali je v skladu s poglavjem II Priloge XV dosje vloge popoln.
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 investigation;
Sponzor v enem tednu po tem, ko pride v zvezi z dokumentacijo iz poglavja II Priloge XV do kakršne koli spremembe, v elektronskem sistemu iz člena 73 posodobi ustrezne podatke in poskrbi, da je zadevna sprememba dokumentacije jasno prepoznavna.
there are scientific grounds to expect that participation of the subject in the clinical investigation 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;
Zadevna država članica je o posodobitvi uradno obveščena prek navedenega elektronskega sistema.
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;
Če zadevna država članica ugotovi, da klinična raziskava, za katero je bila vložena vloga, ne spada v področje uporabe te uredbe ali da dosje vloge ni popoln, o tem obvesti sponzorja in določi rok največ deset dni, v katerih lahko sponzor prek elektronskega sistema iz člena 73 predloži pripombe ali dopolni vlogo.
the investigator certifies that he or she is not aware of any objections to participate in the clinical investigation previously expressed by the subject;
Zadevna država članica lahko to rok podaljšajo za največ 20 dni, kadar je to ustrezno.
the clinical investigation 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 investigation is of such a nature that it may be conducted exclusively in emergency situations;
Če sponzor v roku iz prvega pododstavka ne predloži nobenih pripomb niti ne dopolni vloge, se šteje, da je vloga zapadla.
the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject's condition.
Če sponzor meni, da vloga spada v področje uporabe te uredbe in/ali da je popolna, zadevna država članica pa se s tem ne strinja, se šteje, da je vloga zavrnjena.
Following an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 63 shall be sought to continue the participation of the subject in the clinical investigation, and information on the clinical investigation shall be given, in accordance with the following requirements:
Zadevna država članica poskrbi, da je v zvezi s takšno zavrnitvijo omogočen postopek pritožbe.
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 63(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
Zadevna država članica sponzorja v petih dneh po prejemu pripomb ali zahtevanih dodatnih informacij uradno obvesti, ali se šteje, da klinična raziskava spada v področje uporabe te uredbe in da je vloga popolna.
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 can be done sooner, and the information referred to in Article 63(2) shall be given as soon as possible to the subject or his or her legally designated representative, as applicable.
Zadevna država članica lahko roka iz odstavkov 1 in 3 podaljša za dodatnih pet dni.
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 investigation shall be obtained from the subject as soon as he or she is capable of giving informed consent.
V tem poglavju se datum, ko je sponzor uradno obveščen v skladu z odstavkom 1 ali 3, šteje za datum potrditve vloge.
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 investigation.
Če sponzor ni uradno obveščen, se za datum potrditve šteje zadnji dan rokov iz odstavkov 1, 3 oziroma 4.
Article 69
V obdobju, v katerem se vloga ocenjuje, lahko država članica od sponzorja zahteva dodatne informacije.
Damage compensation
Tek roka iz točke (b) odstavka 7 se od datuma prvega zahtevka do prejema dodatnih informacij prekine.
Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from participation in a clinical investigation conducted on their territory are in place in the form of insurance, a guarantee, or a similar arrangement that is equivalent as regards its purpose and which is appropriate to the nature and the extent of the risk.
Klinično raziskavo sponzor lahko začne izvajati:
The sponsor and the investigator shall make use of the system referred to in paragraph 1 in the form appropriate for the Member State in which the clinical investigation is conducted.
v primeru, da gre za pripomočke za klinične raziskave, ki so razvrščeni v razred I, ali neinvazivne pripomočke razreda IIa ali IIb, razen če nacionalno pravo ne določa drugače, takoj po datumu potrditve vloge iz odstavka 5, in sicer pod pogojem, da pristojni odbor za etiko v zadevni državi članici v zvezi s klinično raziskavo ni dal negativnega mnenja, ki bi bilo veljavno za celotno zadevno državo članico v skladu z njenim nacionalnim pravom;
Article 70
v primeru, da gre za pripomočke, ki so predmet raziskave, razen tistih iz točke (a), takoj ko zadevna država članica sponzorja uradno obvesti o odobritvi, in sicer pod pogojem, da pristojni odbor za etiko v zadevni državi članici v zvezi s klinično raziskavo ni dal negativnega mnenja, ki bi bilo veljavno za celotno zadevno državo članico v skladu z njenim nacionalnim pravom.
Application for clinical investigations
Država članica sponzorja o odobritvi uradno obvesti v 45 dneh po datumu potrditve iz odstavka 5.
The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the clinical investigation is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Chapter II of Annex XV.
Država članica lahko ta rok podaljša za dodatnih 20 dni zaradi posvetovanja s strokovnjaki.
The application shall be submitted by means of the electronic system referred to in Article 73, which shall generate a Union-wide unique single identification number for the clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, s katerimi zaradi tehničnega napredka in razvoja v mednarodnem ureditvenem okviru spremeni zahteve iz poglavja II Priloge XV.
Within 10 days of it receiving the application, the Member State concerned shall notify the sponsor as to whether the clinical investigation falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter II of Annex XV.
Da bi se zagotovila enotna uporaba zahtev, določenih v poglavju II Priloge XV, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
Within one week of any change occurring in relation to the documentation referred to in Chapter II of Annex XV, the sponsor shall update the relevant data in the electronic system referred to in Article 73 and make that change to the documentation clearly identifiable.
Člen 71
The Member State concerned shall be notified of the update by means of that electronic system.
Ocena s strani držav članic
Where the Member State concerned finds that the clinical investigation applied for does not fall within the scope of this Regulation or that the application dossier is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 73.
Države članice zagotovijo, da osebe, ki preverjajo in ocenjujejo vlogo ali o njej odločajo, niso izpostavljene nasprotju interesov, so neodvisne od sponzorja, raziskovalcev, ki sodelujejo pri raziskavi, ter fizičnih ali pravnih oseb, ki financirajo klinično raziskavo, ter so tudi sicer nepristranske.
The Member State concerned may extend this period by a maximum of 20 days where appropriate.
Države članice zagotovijo, da pri oceni sodeluje ustrezno število oseb, ki imajo skupaj potrebne kvalifikacije in izkušnje.
Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed.
Države članice ocenijo, ali je klinična raziskava zasnovana tako, da so po minimizaciji tveganj morebitna preostala tveganja za udeležence ali tretje osebe glede na pričakovane klinične koristi upravičena.
Where the sponsor considers the application does fall under the scope of this Regulation and/or is complete but the Member State concerned does not, the application shall be considered to have been rejected.
Ob upoštevanju veljavnih skupnih specifikacij ali harmoniziranih standardov preučijo zlasti:
The Member State concerned shall provide for an appeal procedure in respect of such refusal.
ali je bila dokazana skladnost pripomočkov ali pripomočka, ki je predmet raziskave, z veljavnimi splošnimi zahtevami glede varnosti in učinkovitosti, razen kar zadeva vidike, ki so zajeti v klinični raziskavi, in ali so bili v zvezi s temi vidiki sprejeti vsi previdnostni ukrepi za zaščito zdravja in varnosti udeležencev.
The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the clinical investigation is considered as falling within the scope of this Regulation and the application is complete.
To po potrebi vključuje testiranje tehnične in biološke varnosti in predklinično oceno;
The Member State concerned may also extend the period referred to in paragraph 1 and 3 each by a further five days.
ali so rešitve za zmanjšanje tveganja, ki jih uporablja sponzor, opisane v harmoniziranih standardih, ter v primerih, ko sponzor ne uporablja harmoniziranih standardov, ali rešitve za minimizacijo tveganj zagotavljajo raven zaščite, ki je enakovredna tisti, ki jo zagotavljajo harmonizirani standardi;
For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application.
ali so ukrepi, načrtovani za varno montažo, dajanje v uporabo in vzdrževanje pripomočka, ki je predmet raziskave, ustrezni;
Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively.
zanesljivost in ponovljivost podatkov, pridobljenih v okviru klinične raziskave, ob upoštevanju statistične obdelave, zasnove raziskave in metodoloških vidikov, vključno z velikostjo vzorca, primerjalnim pripomočkom in merili učinkovitosti;
During the period when the application is being assessed, the Member State may request additional information from the sponsor.
izpolnjevanje zahtev iz Priloge XV;
The expiry of the period laid down in point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received.
pri pripomočkih za sterilno uporabo dokaze o potrditvi proizvajalčevih postopkov sterilizacije ali informacije o postopkih obnavljanja in sterilizacije, ki jih je treba izvesti na mestu raziskave;
The sponsor may start the clinical investigation in the following circumstances:
dokazovanje varnosti, kakovosti in uporabnosti vseh sestavin živalskega ali človeškega izvora ali snovi, ki lahko štejejo za zdravila v skladu z Direktivo 2001/83/ES.