natgillin/translations-raw huggingface dataset:
Performance studies shall be subject to scientific and ethical review.
Podaci i zaključci do kojih se došlo ocjenjivanjem tih elemenata predstavljaju kliničke dokaze za proizvod.
The ethical review shall be performed by an ethics committee in accordance with national law.
Klinički dokazi takvi su da se njima znanstveno dokazuje, upućivanjem na najnovija dostignuća u medicini, da će predviđena klinička korist (koristi) biti postignuta i da je proizvod siguran.
Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study.
Klinički dokazi proizašli iz procjene učinkovitosti pružaju znanstveno valjano jamstvo da su, u normalnim uvjetima uporabe, ispunjeni relevantni opći zahtjevi sigurnosti i učinkovitosti utvrđeni u Prilogu I.
At least one lay person shall participate in the ethical review.
Studije kliničke učinkovitosti u skladu s Prilogom XIII. dijelom A odjeljkom 2. provode se, osim ako je valjano opravdano pouzdati se u druge izvore podataka o kliničkoj učinkovitosti.
Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.
Procjena učinkovitosti i popratna dokumentacija ažuriraju se tijekom cijeloga životnog ciklusa dotičnog proizvoda podacima dobivenim provedbom proizvođačeva plana za posttržišno praćenje učinkovitosti u skladu s Prilogom XIII. dijelom B. i planom za posttržišni nadzor iz članka 79.
Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation.
Podaci iz prvog podstavka upotrebljavaju se za ažuriranje izvješća o procjeni učinkovitosti za proizvode klase C i D kada je potrebno, a najmanje jednom godišnje.
Any communication with that legal representative shall be deemed to be a communication with the sponsor.
Sažetak o sigurnosti i učinkovitosti iz članka 29. stavka 1. ažurira se, kada je to potrebno, u što kraćem roku.
Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation.
Ako je potrebno osigurati jedinstvenu primjenu Priloga XIII.
A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
Komisija može, uzimajući u obzir tehnički i znanstveni napredak, donositi provedbene akte u onoj mjeri u kojoj je to potrebno za rješavanje pitanja različitih tumačenja i praktične primjene.
the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated;
Članak 57.
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law;
Opći zahtjevi u pogledu studija učinkovitosti
the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union;
Proizvođač osigurava da proizvod za studiju učinkovitosti ispunjava opće zahtjeve sigurnosti i učinkovitosti određene u Prilogu I., osim aspekata obuhvaćenih studijom učinkovitosti u pogledu kojih su poduzete sve mjere opreza u svrhu zaštite zdravlja i sigurnosti pacijenta, korisnika i drugih osoba.
vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;
Studije učinkovitosti provode se, prema potrebi, u okolnostima sličnima normalnim uvjetima uporabe proizvoda.
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
Studije učinkovitosti osmišljavaju se i provode tako da su prava, sigurnost, dostojanstvo i dobrobit ispitanika koji sudjeluju u takvim studijama učinkovitosti zaštićeni i da prevladavaju nad svim drugim interesima te da su dobiveni podaci znanstveno valjani, pouzdani i čvrsto utemeljeni.
the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with Article 59;
Studije učinkovitosti, uključujući studije učinkovitosti u kojima se upotrebljavaju preostali uzorci, provode se u skladu s primjenjivim pravom o zaštiti podataka.
the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;
Članak 58.
the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
Dodatni zahtjevi za određene studije učinkovitosti
the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored;
Sve studije učinkovitosti:
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study conditions;
u kojima se kirurško invazivno uzimanje uzoraka obavlja samo u svrhe studije učinkovitosti;
no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study;
koje su intervencijske studije kliničke učinkovitosti kako je definirano u članku 2. točki 37. ili
where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted;
ako provedba studije uključuje dodatne invazivne postupke ili druge rizike za ispitanike studija,
in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art;
uz zahtjeve utvrđene u članku 57. i Prilogu XIII., osmišljene su, odobrene, provode se i bilježe te se o njima izvješćuje u skladu s ovim člankom te člancima od 59. do 77. i Prilogom XIV.
in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art.
Studije učinkovitosti kojima je obuhvaćena prateća dijagnostika podliježu istim zahtjevima kao studije učinkovitosti navedene u stavku 1.
Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;
Studije učinkovitosti predmet su znanstvenog i etičkog preispitivanja.
the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention;
Etičko preispitivanje obavlja etičko povjerenstvo u skladu s nacionalnim pravom.
the requirements of Annex XIV are fulfilled.
Države članice osiguravaju da su postupci za preispitivanje koje provode etička povjerenstva usklađeni s postupcima utvrđenima ovom Uredbom za ocjenjivanje zahtjeva za odobrenje studije učinkovitosti.
Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent.
U etičkom preispitivanju sudjeluje najmanje jedan laik.
Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.
Ako naručitelj studije učinkovitosti nema poslovni nastan u Uniji, taj naručitelj osigurava da određena fizička ili pravna osoba ima poslovni nastan u Uniji kao njegov pravni zastupnik.
The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine.
Takav pravni zastupnik odgovoran je za osiguravanje usklađenosti s obvezama naručitelja u skladu s ovom Uredbom te je nadležan za svu komunikaciju s naručiteljem predviđenu ovom Uredbom.
Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
Sva komunikacija s navedenim pravnim zastupnikom smatra se komunikacijom s naručiteljem.
Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
Države članice mogu odlučiti ne primijeniti prvi podstavak na studije učinkovitosti koje se provode isključivo na njihovu državnom području ili na njihovu državnom području i državnom području treće zemlje, pod uvjetom da osiguraju da naručitelj odredi na njihovu državnom području u vezi s tom studijom učinkovitosti barem osobu za kontakt koja je nadležna za svu komunikaciju s naručiteljem predviđenu ovom Uredbom.
Article 59
Studija učinkovitosti iz stavka 1. može se provoditi samo ako su ispunjeni svi sljedeći uvjeti:
Informed consent
studija učinkovitosti podliježe odobrenju dotične države članice (dotičnih država članica) u kojoj (kojima) se studija učinkovitosti treba provoditi u skladu s ovom Uredbom, osim ako je navedeno drugačije;
Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2.
etičko povjerenstvo, uspostavljeno u skladu s nacionalnim pravom, nije dalo negativno mišljenje o studiji učinkovitosti koje vrijedi u toj cijeloj državi članici u skladu s njezinim nacionalnim pravom;
Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness.
naručitelj ili njegov pravni zastupnik ili osoba za kontakt u skladu sa stavkom 2. ima poslovni nastan u Uniji;
In that case, the witness shall sign and date the informed consent document.
osjetljiva populacija i ispitanici zaštićeni su na odgovarajući način u skladu s člancima od 59. do 64.;
The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given.
očekivana korist za ispitanike ili za javno zdravlje opravdavaju predvidljive rizike i smetnje te se stalno prati usklađenost s tim uvjetom;
The informed consent shall be documented.
ispitanik ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegov zakonito imenovani zastupnik dao je informirani pristanak u skladu s člankom 59.;
Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the performance study.
ispitanik ili, kada ispitanik nije u mogućnosti dati informirani pristanak, njegov zakonito imenovani zastupnik, dobio je kontaktne podatke subjekta u kojem se u slučaju potrebe mogu dobiti dodatne informacije;
Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
prava ispitanika na fizički i mentalni integritet, privatnost i zaštitu podataka koji se odnose na njega u skladu s Direktivom 95/46/EZ zaštićena su;
enable the subject or his or her legally designated representative to understand:
studija učinkovitosti osmišljena je tako da bude što manje boli, neugode, straha i drugog predvidljivog rizika za ispitanike, a prag rizika i stupanj boli posebno su određeni u planu studije učinkovitosti i stalno se promatraju;
the nature, objectives, benefits, implications, risks and inconveniences of the performance study;
zdravstvena skrb koja se pruža ispitanicima odgovornost je prikladno kvalificiranog liječnika ili, prema potrebi, druge osobe koja je u skladu s nacionalnim pravom ovlaštena pružati odgovarajuću njegu pacijenata u uvjetima studije učinkovitosti;
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification;
na ispitanika ili, ako je primjenjivo, na njegove zakonito imenovane zastupnike nije izvršen nikakav nedopustiv utjecaj, uključujući onaj financijske prirode, kako bi sudjelovali u studiji učinkovitosti;
the conditions under which the performance study is to be conducted, including the expected duration of the subject's participation in the performance study; and
provedeno je, prema potrebi, testiranje biološke sigurnosti kojime se uzimaju u obzir najnovije znanstvene spoznaje ili bilo koji drugi test koji se smatra potrebnim s obzirom na namjenu proizvoda;
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued;
u slučaju studija kliničke učinkovitosti dokazana je analitička učinkovitost, uzimajući u obzir najnovija dostignuća;
be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
u slučaju intervencijskih studija kliničke učinkovitosti dokazane su analitička učinkovitost i znanstvena valjanost, uzimajući u obzir najnovija dostignuća.
be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law; and
Ako nije ustanovljena znanstvena valjanost prateće dijagnostike, navodi se znanstveno obrazloženje za uporabu biomarkera;
include information about the applicable damage compensation system referred to in Article 65;
dokazana je tehnička sigurnost proizvoda s obzirom na njegovu uporabu, vodeći računa o najnovijim dostignućima te odredbama u području sigurnosti na radu i sprečavanja štetnih događaja;
include the Union-wide unique single identification number for the performance study referred to in Article 66(1) and information about the availability of the performance study results in accordance with paragraph 6 of this Article.
ispunjeni su zahtjevi iz Priloga XIV.
The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
Svaki se ispitanik ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegov zakonito imenovani zastupnik, bez prouzročene štete i bez obrazloženja može povući iz studije učinkovitosti u svakom trenutku opozivanjem svojeg prethodnog informiranog pristanka.
In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
Ne dovodeći u pitanje Direktivu 95/46/EZ, povlačenje informiranog pristanka ne utječe na aktivnosti koje su već provedene i na uporabu podataka dobivenih na temelju informiranog pristanka prije njegova povlačenja.
In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
Ispitivač je osoba kojoj zvanje omogućuje da se u dotičnoj državi članici bavi aktivnošću ispitivača zahvaljujući potrebnom znanstvenom znanju i iskustvu u njezi pacijenata ili laboratorijskoj medicini.
The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be made available pursuant to Article 73(5) in the electronic system on performance studies referred to in Article 69, irrespective of the outcome of the performance study, and shall be informed, to the extent possible, when they have become available.
Drugo osoblje uključeno u provedbu studije učinkovitosti odgovarajuće je kvalificirano obrazovanjem, izobrazbom ili iskustvom u odgovarajućem području medicine i metodologiji kliničkih istraživanja za obavljanje svojih zadaća.
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 performance study.
Ako je to prikladno, prostori u kojima se provodi studija učinkovitosti u kojoj sudjeluju ispitanici primjereni su za studiju učinkovitosti te slični prostorima u kojima se proizvod namjerava upotrebljavati.
Article 60
Članak 59.
Performance studies on incapacitated subjects
Informirani pristanak
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 performance study may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
Osoba koja obavlja razgovor iz stavka 2. točke (c) i ispitanik ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegov zakonito imenovani zastupnik daju pisani, datirani i potpisani informirani pristanak nakon što su pravodobno informirani u skladu sa stavkom 2.
the informed consent of their legally designated representative has been obtained;
Ako ispitanik ne može pisati, pristanak se može dati i snimiti drugim odgovarajućim sredstvima u prisutnosti barem jednog nepristranog svjedoka.
the incapacitated subjects have received the information referred to in Article 59(2) in a way that is adequate in view of their capacity to understand it;
U tom slučaju svjedok potpisuje i datira informirani pristanak.
the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;
Ispitaniku ili, ako ispitanik ne može dati informirani pristanak, njegovu zakonito imenovanom zastupniku daje se primjerak dokumenta ili snimke, prema potrebi, kojima je informirani pristanak dan.
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 performance study;
Informirani se pristanak dokumentira.
the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods;
Ispitaniku ili njegovu zakonito imenovanom zastupniku vremena daje se odgovarajuće vrijeme kako bi odlučio hoće li sudjelovati u studiji učinkovitosti.
the performance study relates directly to a medical condition from which the subject suffers;
Podaci dani ispitaniku ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegovu zakonito imenovanom zastupniku u svrhu dobivanja njegovog informiranog pristanka:
there are scientific grounds for expecting that participation in the performance study will produce:
omogućuju ispitaniku ili njegovu zakonito imenovanom zastupniku da razumiju
a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or
i. vrstu, ciljeve, koristi, posljedice, rizike i smetnje studije učinkovitosti;
some benefit for the population represented by the incapacitated subject concerned when the performance study 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.
prava ispitanika i garanciju u pogledu njegove zaštite, posebno njegovo pravo na odbijanje sudjelovanja u studiji učinkovitosti i pravo na povlačenje iz nje u svakom trenutku bez prouzročene štete i davanja obrazloženja;
The subject shall as far as possible take part in the informed consent procedure.
uvjete po kojima se studija učinkovitosti treba provoditi; uključujući očekivano trajanje sudjelovanja ispitanika u studiji učinkovitosti i
Point (g)(ii) of paragraph 1 shall be without prejudice to more stringent national rules prohibiting the conduct of those performance studies on incapacitated subjects, where there are no scientific grounds to expect that participation in the performance study will produce a direct benefit to the subject outweighing the risks and burdens involved.
moguće alternative liječenju, uključujući mjere praćenja ako ispitanik prestane sudjelovati u studiji učinkovitosti;
Article 61
sveobuhvatni su, koncizni, jasni, relevantni i razumljivi ispitaniku ili njegovu zakonito imenovanom zastupniku;
Performance studies on minors
daju se u prethodnom razgovoru s članom istraživačkog tima koji je odgovarajuće kvalificiran prema nacionalnom pravu te
A performance study on minors may be conducted only where, in addition to the conditions set out in Article 58(5), all of the following conditions are met:
obuhvaćaju informacije o mjerodavnom sustavu naknade štete iz članka 65..;
the minors have received the information referred to in Article 59(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;
uključuju jedinstveni identifikacijski broj unikatan na razini Unije za studiju učinkovitosti iz članka 66. stavka 1. i informacije o dostupnosti rezultata studije učinkovitosti u skladu sa stavkom 6. ovog članka.
the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 59(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;
Informacije iz stavka 2. pripremaju se u pisanom obliku i dostupne su ispitaniku ili, kada ispitanik nije u mogućnosti dati informirani pristanak, njegovu zakonito imenovanom zastupniku.
the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods;
Tijekom razgovora iz stavka 2. točke (c) posebna se pozornost daje potrebi za informiranjem posebnih populacija pacijenata i pojedinačnih ispitanika, kao i metodama koje se koriste za davanje informacija.
the performance study 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;
U razgovoru iz stavka 2. točke (c) provjerava se da je ispitanik razumio informacije.