natgillin/translations-raw huggingface dataset:
Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and prevail over all other interests and the clinical data generated are scientifically valid, reliable and robust.
očekivana korist za ispitanike ili javno zdravlje opravdava predvidljive rizike i smetnje, uz stalno praćenje ispunjavanja tog uvjeta;
Clinical investigations shall be subject to scientific and ethical review.
ispitanik ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegov zakonito imenovani zastupnik dao je informirani pristanak u skladu s člankom 63.;
The ethical review shall be performed by an ethics committee in accordance with national law.
ispitanik ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegov zakonito imenovani zastupnik, dobio je kontaktne podatke tijela u kojem se u slučaju potrebe mogu dobiti dodatne informacije;
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 clinical investigation.
zaštićena su prava ispitanika na fizički i mentalni integritet, privatnost i zaštitu podataka koji se odnose na njega u skladu s Direktivom 95/46/EZ;
At least one lay person shall participate in the ethical review.
kliničko ispitivanje osmišljeno je tako da bude što manje boli, neugode, straha ili drugog predvidljivog rizika za ispitanika, a prag rizika i stupanj boli posebno su određeni u planu kliničkog ispitivanja i stalno se prate;
A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
za zdravstvenu skrb koja se pruža ispitanicima odgovoran je odgovarajuće kvalificiran liječnik ili, prema potrebi, kvalificiran doktor dentalne medicine ili bilo koja druga osoba koja je okviru nacionalnog prava ovlaštena za pružanje relevantne njege pacijentima u uvjetima kliničkog ispitivanja;
the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
na ispitanika ili, ako je primjenjivo, na njegove zakonito imenovane zastupnike nije izvršen nikakav nedopušten utjecaj, uključujući onaj financijske prirode, kako bi sudjelovali u kliničkom ispitivanju;
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;
proizvodi koji se ispituju sukladni su s primjenjivim općim zahtjevima sigurnosti i učinkovitosti određene u Prilogu I., uz aspekte obuhvaćene kliničkim ispitivanjem, i u skladu s tim aspektima poduzete su sve mjere opreza kako bi se zaštitilo zdravlje i sigurnost ispitanika.
the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;
To uključuje, prema potrebi, testiranje tehničke i biološke sigurnosti te pretkliničku procjenu, kao i odredbe u području sigurnosti na radu i sprečavanja nesreća, uzimajući u obzir najnovija dostignuća;
vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
ispunjeni su zahtjevi iz Priloga XV.
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
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 kliničkog ispitivanja u svakom trenutku opozivanjem svog prethodnog informiranog pristanka.
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 63;
Ne dovodeći u pitanje Direktivu 95/46/EZ, povlačenje informiranog pristanka ne utječe na aktivnosti koje se već provode i na uporabu podataka dobivenih na temelju informiranog pristanka prije njegova povlačenja.
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;
Ispitivač je osoba kojoj zvanje omogućuje da se u dotičnoj državi članici bavi aktivnošću ispitivača zahvaljujući potrebnom znanstvenom znanju i iskustvu u njezi pacijenata.
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;
Drugi članovi osoblja koji su uključeni u provedbu kliničkog ispitivanja na odgovarajući su način kvalificirani obrazovanjem, izobrazbom ili iskustvom u odgovarajućem području medicine i metodologiji kliničkih istraživanja za obavljanje svojih zadaća.
the clinical investigation 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 clinical investigation plan and constantly monitored;
Prostori u kojima se kliničko ispitivanje treba provesti prikladni su za kliničko ispitivanje i slični prostorima u kojima se proizvod namjerava koristiti.
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patient care under clinical investigation conditions;
Članak 63.
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 clinical investigation;
Informirani pristanak
the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects.
Osoba koja obavlja razgovor naveden u stavku 2. točki (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 propisno informirani u skladu sa stavkom 2.
This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;
Ako ispitanik ne može pisati, pristanak se može dati i snimiti drugim odgovarajućim sredstvima u prisutnosti barem jednog nepristranog svjedoka.
the requirements of Annex XV are fulfilled.
U tom slučaju svjedok potpisuje i datira informirani pristanak.
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 clinical investigation at any time by revoking his or her informed consent.
Ispitaniku ili, ako ispitanik ne može dati informirani pristanak, njegovu zakonito imenovanom zastupniku daje se primjerak dokumenta ili, prema potrebi, drugačijeg zapisa kojim je dan informirani pristanak.
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.
Informirani pristanak se dokumentira.
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.
Ispitaniku ili njegovu zakonito imenovanom zastupniku daje se odgovarajuće vrijeme kako bi odlučio hoće li sudjelovati u kliničkom ispitivanju.
Other personnel involved in conducting a clinical investigation shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
Podaci dani ispitaniku ili, ako ispitanik nije u mogućnosti dati informirani pristanak, njegovom zakonito imenovanom zastupniku u svrhu dobivanja njegova informiranog pristanka:
The facilities where the clinical investigation is to be conducted shall be suitable for the clinical investigation and shall be similar to the facilities where the device is intended to be used.
omogućuju ispitaniku ili njegovu zakonito imenovanom zastupniku da razumiju:
Article 63
i. vrstu, ciljeve, korist, posljedice, rizike i smetnje u vezi s kliničkim ispitivanjem;
Informed consent
prava ispitanika i garancije u pogledu njegove zaštite, posebno njegovo pravo na odbijanje sudjelovanja u kliničkom ispitivanju i pravo na povlačenje iz njega u svakom trenutku bez prouzročene štete i davanja obrazloženja;
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.
uvjete pod kojima se kliničko ispitivanje treba provoditi, uključujući očekivano trajanje sudjelovanja ispitanika u kliničkom ispitivanju i
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.
moguće alternative liječenju, uključujući mjere praćenja ako ispitanik prestane sudjelovati u kliničkom ispitivanju;
In that case, the witness shall sign and date the informed consent document.
sveobuhvatni su, koncizni, jasni, relevantni i razumljivi ispitaniku ili njegovu zakonito imenovanom zastupniku;
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.
daju se u prethodnom razgovoru s članom istraživačkog tima koji je odgovarajuće kvalificiran prema nacionalnom pravu;
The informed consent shall be documented.
obuhvaćaju informacije o mjerodavnom sustavu naknade štete navedenom u članku 69. i
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 clinical investigation.
obuhvaćaju jedinstveni identifikacijski broj na razini Unije za kliničko ispitivanje iz članka 70. stavka 1. i informacije o dostupnosti rezultata kliničkog ispitivanja u skladu sa stavkom 6. ovog članka.
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:
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.
enable the subject or his or her legally designated representative to understand:
Tijekom razgovora navedenog u stavku 2. točki (c) posebna se pozornost daje potrebi za informiranjem posebnih populacija pacijenata i pojedinačnih ispitanika, kao i metodama koje se koriste za davanje informacija.
the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
U razgovoru navedenom u stavku 2. točki (c) provjerava se je li ispitanik razumio informacije.
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 clinical investigation at any time without any resulting detriment and without having to provide any justification;
Ispitanika se obavješćuje da će izvješće o kliničkom ispitivanju i sažetak koji je razumljiv predviđenom korisniku biti stavljeni na raspolaganje u skladu s člankom 77. stavkom 5. u elektroničkom sustavu o kliničkim ispitivanjima iz članka 73., neovisno o ishodu kliničkog ispitivanja, te ga se obavješćuje, koliko je to moguće, kada postanu dostupni.
the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and
Ovom Uredbom ne dovodi se u pitanje nacionalno pravo kojim se zahtijeva da se, uz informirani pristanak koji je dao zakonito imenovani zastupnik, maloljetnik koji je sposoban stvoriti mišljenje i procijeniti informacije koje su mu dane, također složi sa sudjelovanjem u kliničkom ispitivanju.
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued;
Članak 64.
be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
Klinička ispitivanja na onesposobljenim ispitanicima
be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law;
U slučaju onesposobljenih ispitanika koji nisu dali informirani pristanak, ili ga nisu odbili dati, prije početka svoje onesposobljenosti, kliničko ispitivanje može se provoditi samo ako su, uz uvjete utvrđene u članku 62. stavku 4., ispunjeni svi sljedeći uvjeti:
include information about the applicable damage compensation system referred to in Article 69; and
dobiven je informirani pristanak njihovih zakonito imenovanih zastupnika;
include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article.
onesposobljeni ispitanici dobili su informacije iz članka 63. stavka 2. na način koji je prikladan imajući u vidu njihovu sposobnost razumijevanja tih informacija;
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.
ispitivač poštuje izričitu želju onesposobljenog ispitanika koji je sposoban stvoriti mišljenje i procijeniti informaciju iz članka 63. stavka 2. da odbije sudjelovati u kliničkom ispitivanju ili da se u bilo kojem trenutku iz njega povuče;
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.
ispitanicima ili njihovim zakonito imenovanim zastupnicima ne daju se nikakvi financijski poticaji, osim naknade za troškove i gubitak zarade koji je izravno povezan sa sudjelovanjem u kliničkom ispitivanju;
In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
kliničko ispitivanje nužno je u odnosu na onesposobljene ispitanike, a podaci usporedive valjanosti ne mogu se dobiti u kliničkim ispitivanjima na osobama koje su u stanju dati informirani pristanak ili drugim metodama istraživanja;
The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be made available pursuant to Article 77(5) in the electronic system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical investigation, and shall be informed, to the extent possible, when they have become available.
kliničko ispitivanje izravno se odnosi na medicinsko stanje od kojeg ispitanik pati;
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.
znanstveno je utemeljeno očekivati da će sudjelovanje u kliničkom ispitivanju donijeti izravnu korist onesposobljenom ispitaniku i premašiti uključene rizike i opterećenja.
Article 64
Ispitanik sudjeluje u postupku davanja informiranog pristanka koliko je to moguće.
Clinical investigations on incapacitated subjects
Članak 65.
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:
Klinička ispitivanja na maloljetnicima
the informed consent of their legally designated representative has been obtained;
Kliničko ispitivanje na maloljetnicima može se provoditi samo ako su, osim uvjeta navedenih u članku 62. stavku 4., ispunjeni svi sljedeći uvjeti:
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;
maloljetnici su dobili informacije iz članka 63. stavka 2. na način prilagođen njihovoj dobi i mentalnoj zrelosti i od ispitivača ili članova ispitivačkog tima koji su osposobljeni za rad s djecom ili imaju iskustva u tome;
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;
ispitivač poštuje izričitu želju maloljetnika koji je sposoban stvoriti mišljenje i procijeniti informacije iz članka 63. stavka 2. da odbije sudjelovati u kliničkom ispitivanju ili da se u bilo kojem trenutku iz njega povuče;
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;
ispitaniku ili njegovu zakonito imenovanom zastupniku ne daju se nikakvi financijski poticaji osim naknade za troškove i gubitak zarade koji je izravno povezan sa sudjelovanjem u kliničkom ispitivanju;
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;
namjera kliničkog ispitivanja jest ispitati liječenja za medicinsko stanje koje se pojavljuje samo kod maloljetnika ili je kliničko ispitivanje nužno u odnosu na maloljetnike kako bi se potvrdili podaci dobiveni u kliničkim ispitivanjima na osobama koje su u stanju dati informirani pristanak ili drugim metodama istraživanja;
the clinical investigation relates directly to a medical condition from which the subject suffers;
kliničko ispitivanje izravno je povezano s medicinskim stanjem od kojeg dotični maloljetnik pati ili je takve prirode da se može provesti samo na maloljetnicima;
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.
znanstveno je utemeljeno očekivati da će sudjelovanje u kliničkom ispitivanju donijeti izravnu korist maloljetnom ispitaniku i premašiti uključene rizike i opterećenja;
The subject shall as far as possible take part in the informed consent procedure.
maloljetnik sudjeluje u postupku davanja informiranog pristanka na način prilagođen njegovoj dobi i mentalnoj zrelosti;
Article 65
ako tijekom kliničkog ispitivanja maloljetnik dosegne dob pravne sposobnosti za davanje informiranog pristanka kako je određeno u nacionalnom pravu, njegov izričit informirani pristanak pribavlja se prije nego što taj ispitanik može nastaviti sudjelovati u kliničkom ispitivanju.
Clinical investigations on minors
Članak 66.
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:
Klinička ispitivanja na trudnicama ili dojiljama
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;
Kliničko ispitivanje na trudnicama ili dojiljama može se provoditi samo ako su, osim uvjeta navedenih u članku 62. stavku 4., ispunjeni svi sljedeći uvjeti:
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;
kliničko ispitivanje ima potencijala proizvesti izravnu korist za trudnice ili dojilje ili njihov zametak, plod ili dijete nakon rođenja te premašuje rizike i uključena opterećenja;
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;
kada se istraživanje provodi na ženama koje doje, posebna se briga vodi da se izbjegne svaki nepoželjan utjecaj na zdravlje djeteta;
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;
ispitaniku se ne daju nikakvi financijski poticaji osim naknade za troškove i gubitak zarade koji je izravno povezan sa sudjelovanjem u kliničkom ispitivanju.
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;
Članak 67.
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;
Dodatne nacionalne mjere
the minor shall take part in the informed consent procedure in a way adapted to his or her age and mental maturity;
Države članice mogu zadržati dodatne mjere u pogledu osoba koje služe obvezni vojni rok, osoba lišenih slobode, osoba koje zbog sudske odluke ne mogu sudjelovati u kliničkim ispitivanjima ili osoba koje su smještene u ustanove za zdravstvenu njegu.
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.
Članak 68.
Article 66
Klinička ispitivanja u hitnim situacijama
Clinical investigations on pregnant or breastfeeding women
Odstupajući od članka 62. stavka 4. točke (f), članka 64. stavka 1. točaka (a) i (b) i članka 65. točaka (a) i (b), informirani pristanak za sudjelovanje u kliničkom ispitivanju može se dobiti i informacije o kliničkom ispitivanju mogu se dati, nakon odluke da se ispitanik uključi u kliničko ispitivanje uz uvjet da je ta odluka donesena u trenutku prve intervencije na ispitaniku, u skladu s planom tog kliničkog ispitivanja i da su ispunjeni svi sljedeći uvjeti:
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:
zbog hitnosti situacije izazvane iznenadnim po život opasnim ili drugim iznenadnim ozbiljnim medicinskim stanjem, ispitanik nije u mogućnosti dati prethodni informirani pristanak i dobiti prethodne informacije o kliničkom ispitivanju;