natgillin/translations-raw huggingface dataset:
When determining the appropriate body or bodies, Member States should ensure the involvement of laypersons, in particular patients or patients' organisations.
Države članice bi morale pri določanju ustreznega organa ali organov zagotoviti sodelovanje nestrokovnjakov, zlasti pacientov oziroma organizacij pacientov.
They should also ensure that the necessary expertise is available.
Zagotoviti bi morale tudi potrebno strokovno znanje.
In accordance with international guidelines, the assessment should be done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience.
V skladu z mednarodnimi smernicami bi vlogo moralo skupaj ocenjevati ustrezno število oseb, ki imajo skupaj potrebne kvalifikacije in izkušnje.
The persons assessing the application should be independent of the sponsor, the clinical trial site, and the investigators involved, as well as free from any other undue influence.
Osebe, ki ocenjujejo vlogo, bi morale biti neodvisne od sponzorja, mesta, kjer poteka klinično preskušanje, in vključenih raziskovalcev ter tudi v drugih pogledih nepristranske.
The assessment of applications for the authorisation of clinical trials should be conducted on the basis of appropriate expertise.
Ocenjevanje vlog za odobritev kliničnega preskušanja bi bilo treba opraviti na podlagi ustreznega strokovnega znanja.
Specific expertise should be considered when assessing clinical trials involving subjects in emergency situations, minors, incapacitated subjects, pregnant and breastfeeding women and, where appropriate, other identified specific population groups, such as elderly people or people suffering from rare and ultra rare diseases.
Pri ocenjevanju kliničnega preskušanja, pri katerem sodelujejo udeleženci v nujnih primerih, mladoletniki, nezmožne osebe, nosečnice in doječe matere ter, kjer je primerno, druge opredeljene posebne skupine prebivalstva, kot so starejši ljudje ali osebe, ki trpijo zaradi redkih in zelo redkih bolezni, bi bilo treba razmisliti o posebnem strokovnem znanju.
In practice, sponsors do not always have all the information needed for submitting a complete application for authorisation of a clinical trial in all of the Member States where a clinical trial is eventually going to be conducted.
V praksi sponzorji ne razpolagajo vedno z vsemi potrebnimi informacijami, da bi lahko predložili popolno vlogo za odobritev kliničnega preskušanja v vseh državah članicah, v katerih se bo morda izvajalo klinično preskušanje.
It should be possible for sponsors to submit an application solely on the basis of documents assessed jointly by those Member States where the clinical trial might be conducted.
Sponzorjem bi moralo biti omogočeno, da predložijo vlogo samo na podlagi dokumentov, ki so jih skupno ocenile države članice, v katerih se bo morda izvajalo klinično preskušanje.
The sponsor should be allowed to withdraw the application for authorisation of a clinical trial.
Sponzor bi moral imeti možnost umika vloge za odobritev kliničnega preskušanja.
To ensure the reliable functioning of the assessment procedure, however, an application for authorisation of a clinical trial should be withdrawn only for the entire clinical trial.
Da se zagotovi zanesljivost postopka ocenjevanja, pa bi bilo treba vlogo za odobritev kliničnega preskušanja umakniti samo za celotno klinično preskušanje.
It should be possible for the sponsor to submit a new application for authorisation of a clinical trial following the withdrawal of an application.
Sponzor bi moral po umiku vloge imeti možnost predložitve nove vloge za odobritev kliničnega preskušanja.
In practice, in order to reach recruitment targets or for other reasons, sponsors may have an interest in extending the clinical trial to an additional Member States after the initial authorisation of the clinical trial.
V praksi bi morda sponzorji po prvotni odobritvi kliničnega preskušanja zaradi zagotovitve ustreznega števila udeležencev ali iz drugih razlogov želeli razširiti klinično preskušanje v dodatno državo članico.
An authorisation mechanism should be provided to allow for such extension, while avoiding the re-assessment of the application by all the Member States concerned which were involved in the initial authorisation of the clinical trial.
Za to razširitev bi bilo treba predvideti mehanizem odobritve, pri katerem vsem zadevnim državam članicam, ki so sodelovale pri prvotnem postopku odobritve kliničnega preskušanja, ne bi bilo treba ponovno ocenjevati vloge.
Clinical trials are usually subject to many modifications after they have been authorised.
Klinična preskušanja se po odobritvi običajno še precej spremenijo.
Those modifications may relate to the conduct, the design, the methodology, the investigational or auxiliary medicinal product, or the investigator or clinical trial site involved.
Spremembe se lahko nanašajo na izvajanje, načrtovanje, metodologijo, zdravila v preskušanju ali pomožna zdravila ali na raziskovalca ali mesto kliničnega preskušanja.
Where those modifications have a substantial impact on the safety or rights of the subjects or on the reliability and robustness of the data generated in the clinical trial, they should be subject to an authorisation procedure similar to the initial authorisation procedure.
Kadar te spremembe bistveno vplivajo na varnost ali pravice udeležencev ali na zanesljivost in ponovljivost podatkov iz kliničnega preskušanja, bi zanje moral veljati postopek odobritve, podobnem prvotnemu postopku odobritve.
The content of the application dossier for authorisation of a clinical trial should be harmonised in order to ensure that all Member States have the same information available and to simplify the application process for clinical trials.
Vsebina dosjeja vloge za odobritev kliničnega preskušanja bi morala biti usklajena zaradi zagotavljanja, da imajo vse države članice na voljo iste informacije in da se poenostavi postopek predložitve vlog za klinična preskušanja.
In order to increase transparency in the area of clinical trials, data from a clinical trial should only be submitted in support of a clinical trial application if that clinical trial has been recorded in a publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP).
Za povečanje preglednosti na področju kliničnih preskušanj bi se morali podatki iz kliničnega preskušanja priložiti vlogi za odobritev kliničnega preskušanja samo, če je navedeno klinično preskušanje zabeleženo v zbirki podatkov, ki je javno dostopna in brezplačna in ki predstavlja primarno evidenco ali sorodno evidenco, ali zagotavlja podatke za mednarodni register kliničnih preskušanj Svetovne zdravstvene organizacije (WHO ICTRP).
Data providers to the WHO ICTRP create and manage clinical trial records in a manner that is consistent with the WHO registry criteria.
Osebe, ki zagotavljajo podatke v WHO ICTRP, oblikujejo in upravljajo evidence o kliničnih preskušanjih skladno z merili registra WHO.
Specific provision should be made for data from clinical trials started before the date of application of this Regulation.
Za podatke iz kliničnih preskušanj, začetih pred datumom začetka uporabe te uredbe, bi bilo treba predvideti posebno določbo.
It should be left to Member States to establish the language requirements for the application dossier.
Države članice bi morale same določiti jezik dosjeja vloge.
To ensure that the assessment of the application for authorisation of a clinical trial functions smoothly, Member States should consider accepting a commonly understood language in the medical field as the language for the documentation not destined for the subject.
Za nemoten postopek ocenjevanja vlog za odobritev kliničnega preskušanja bi morale države članice pretehtati možnost dopustitve splošno razumljivega jezika na zdravstvenem področju za dokumentacijo, ki ni namenjena udeležencu.
Human dignity and the right to the integrity of the person are recognised in the Charter of Fundamental Rights of the European Union (the ‘Charter’).
V Listini Evropske unije o temeljnih pravicah (v nadaljnjem besedilu: Listina) sta priznana človekovo dostojanstvo in pravica do osebne celovitosti.
In particular, the Charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned.
Listina zlasti določa, da se nobene intervencije na področju biologije in medicine ne sme izvesti brez svobodne privolitve po predhodni seznanitvi zadevne osebe.
Directive 2001/20/EC contains an extensive set of rules for the protection of subjects.
Direktiva 2001/20/ES vsebuje obsežen sklop pravil za zaščito udeležencev.
These rules should be upheld.
Ta pravila bi bilo treba ohraniti.
Regarding the rules concerning the determination of the legally designated representatives of incapacitated persons and minors, those rules diverge in Member States.
Pravila za določitev zakonito imenovanega zastopnika nezmožnih oseb in mladoletnikov se v državah članicah razlikujejo.
It should therefore be left to Member States to determine the legally designated representatives of incapacitated persons and minors.
Zato bi morale države članice same določiti zakonito imenovanega zastopnika nezmožnih oseb in mladoletnikov.
Incapacitated subjects, minors, pregnant women and breastfeeding women require specific protection measures.
Nezmožne osebe, mladoletniki ter nosečnice in doječe matere potrebujejo posebne zaščitne ukrepe.
An appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner should be responsible for all medical care provided to the subject, including the medical care provided by other medical staff.
Za vso medicinsko oskrbo, ki jo prejme udeleženec, tudi za medicinsko oskrbo, ki jo nudi drugo medicinsko osebje, bi moral biti odgovoren ustrezno kvalificiran zdravnik ali, kjer je to primerno, kvalificiran zobozdravnik.
It is appropriate that universities and other research institutions, under certain circumstances that are in accordance with the applicable law on data protection, be able to collect data from clinical trials to be used for future scientific research, for example for medical, natural or social sciences research purposes.
Ustrezno je, da imajo univerze in druge raziskovalne institucije možnost, da v nekaterih okoliščinah, ki so v skladu z veljavno zakonodajo o varstvu podatkov, zbirajo podatke iz kliničnih preskušanj, ki bodo uporabljeni v prihodnjih znanstvenih raziskavah, na primer za potrebe medicinskih, naravoslovnih ali družbenih znanosti.
In order to collect data for such purposes it is necessary that the subject gives consent to use his or her data outside the protocol of the clinical trial and has the right to withdraw that consent at any time.
Za zbiranje podatkov za take namene mora udeleženec privoliti v uporabo njegovih podatkov zunaj protokola kliničnega preskušanja in ima pravico svojo privolitev kadar koli umakniti.
It is also necessary that research projects based on such data be made subject to reviews that are appropriate for research on human data, for example on ethical aspects, before being conducted.
Zagotoviti je tudi treba, da bodo raziskovalni projekti, ki temeljijo na teh podatkih, še preden se izvedejo, lahko predmet pregledov glede primernosti za raziskovanje podatkov o ljudeh, na primer glede etičnih vidikov.
In accordance with international guidelines, the informed consent of a subject should be in writing.
V skladu z mednarodnimi smernicami bi morala biti prostovoljna privolitev udeleženca po poučitvi v pisni obliki.
When the subject is unable to write, it may be recorded through appropriate alternative means, for instance through audio or video recorders.
Če udeleženec ne more pisati, se privolitev lahko posname z ustreznimi drugimi sredstvi, na primer s snemalnikom zvokov ali videorekorderjem.
Prior to obtaining informed consent, the potential subject should receive information in a prior interview in a language which is easily understood by him or her.
Preden se pridobi prostovoljna privolitev po poučitvi, bi moral potencialni udeleženec prejeti informacije v predhodnem pogovoru in v jeziku, ki je zanj lahko razumljiv.
The subject should have the opportunity to ask questions at any moment.
Udeleženec bi moral imeti možnost, da v vsakem trenutku zastavi vprašanja.
Adequate time should be provided for the subject to consider his or her decision.
Imeti bi moral na voljo dovolj časa, da bi lahko razmislil o svoji odločitvi.
In view of the fact that in certain Member States the only person qualified under national law to perform an interview with a potential subject is a medical doctor while in other Member States this is done by other professionals, it is appropriate to provide that the prior interview with a potential subject should be performed by a member of the investigating team qualified for this task under the national law of the Member State where the recruitment takes place.
Glede na to, da je v nekaterih državah članicah edina oseba, ki je v skladu z nacionalno zakonodajo kvalificirana, da opravi razgovor s potencialnim udeležencem, zdravnik, medtem ko v drugih državah to delajo drugi poklicni strokovnjaki, je ustrezno predvideti, da bi moral predhodni razgovor s potencialnim udeležencem opraviti član raziskovalne skupine, ki je v državi članici, kjer se izvaja nabor, v skladu z nacionalnim pravom kvalificiran za to nalogo.
In order to certify that informed consent is given freely, the investigator should take into account all relevant circumstances which might influence the decision of a potential subject to participate in a clinical trial, in particular whether the potential subject belongs to an economically or socially disadvantaged group or is in a situation of institutional or hierarchical dependency that could inappropriately influence her or his decision to participate.
Za izdajo potrdila, da je bila prostovoljna privolitev po poučitvi dana s svobodno voljo, bi moral raziskovalec upoštevati vse pomembne okoliščine, ki bi lahko vplivale na odločitev potencialnega udeleženca o sodelovanju pri kliničnem preskušanju, zlasti to, ali potencialni udeleženec pripada ekonomsko ali socialno prikrajšani skupini, ter ali je v položaju institucionalne ali hierarhične odvisnosti, ki bi lahko neprimerno vplivala na njegovo odločitev o sodelovanju.
This Regulation should be 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, should himself or herself assent in order to participate in a clinical trial.
Ta uredba ne bi smela posegati v nacionalno pravo, ki zahteva, da bi moral mladoletnik, ki je sposoben oblikovati mnenje in oceniti prejeto informacijo, poleg prostovoljne privolitve po poučitvi, ki jo predloži njegov zakonito imenovani zastopnik, še sam pristati, da se bo udeležil kliničnega preskušanja.
It is appropriate to allow that informed consent be obtained by simplified means for certain clinical trials where the methodology of the trial requires that groups of subjects rather than individual subjects are allocated to receive different investigational medicinal products.
Ustrezno je omogočiti, da se prostovoljna privolitev po poučitvi pridobi na poenostavljen način za nekatera klinična preskušanja, pri katerih metodologija preskušanja zahteva, da se za prejemanje različnih zdravil v preskušanju namesto udeležencev pridobijo skupine posameznikov.
In those clinical trials the investigational medicinal products are used in accordance with the marketing authorisations, and the individual subject receives a standard treatment regardless of whether he or she accepts or refuses to participate in the clinical trial, or withdraws from it, so that the only consequence of non-participation is that data relating to him or her are not used for the clinical trial.
Pri teh kliničnih preskušanjih se zdravila v preskušanju uporabljajo v skladu z dovoljenjem za promet, posamezni udeleženec pa prejme splošno zdravljenje ne glede na to, ali privoli v klinično preskušanje ali ga zavrne, oz. se iz njega umakne, tako da je edina posledica neudeležbe ta, da se podatki o njem ne uporabljajo za klinično preskušanje.
Such clinical trials, which serve to compare established treatments, should always be conducted within a single Member State.
Taka klinična preskušanja, ki služijo primerjavi utečenih zdravljenj, bi bilo treba vedno izvajati le v eni državi članici.
Specific provisions should be defined for the protection of pregnant and breastfeeding women participating in clinical trials and in particular when the clinical trial does not have the potential to produce results of direct benefit to her or to her embryo, foetus or child after birth.
Posebne določbe bi bilo treba določiti za zaščito nosečnic in doječih mater, udeleženih v kliničnih preskušanjih, zlasti kadar klinično preskušanje nima potenciala, da bi njegovi rezultati neposredno koristili ženski ali njenemu zarodku, plodu ali novorojencu.
Persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures.
Osebe, ki služijo obvezni vojaški rok, osebe, ki jim je bila odvzeta prostost, osebe, ki se zaradi pravosodne odločbe ne morejo udeležiti kliničnih preskušanj, ter osebe, ki so zaradi svoje starosti, invalidnosti ali zdravstvenega stanja odvisne od oskrbe in so zaradi tega nastanjene v domovih, to pomeni nastanitve, ki nudijo neprekinjeno pomoč osebam, ki jo potrebujejo, so v podrejenem položaju ali dejansko odvisne in zato lahko potrebujejo posebne zaščitne ukrepe.
Member States should be allowed to maintain such additional measures.
Državam članicam bi moralo biti omogočeno, da take dodatne ukrepe ohranijo.
This Regulation should provide for clear rules concerning informed consent in emergency situations.
Ta uredba bi morala določati jasna pravila glede prostovoljne privolitve po poučitvi v nujnih primerih.
Such situations relate to cases where for example a patient has suffered a sudden life-threatening medical condition due to multiple traumas, strokes or heart attacks, necessitating immediate medical intervention.
To so na primer primeri, ko se denimo pri pacientu pojavi nenadno življenjsko nevarno zdravstveno stanje kot posledica več poškodb, možganskih ali srčnih kapi, pri katerih je potrebna takojšnja medicinska intervencija.
For such cases, intervention within an ongoing clinical trial, which has already been approved, may be pertinent.
V takih primerih je morda upravičena intervencija v okviru potekajočega že odobrenega kliničnega preskušanja.
However, in certain emergency situations, it is not possible to obtain informed consent prior to the intervention.
Vendar pa v določenih nujnih primerih ni mogoče pridobiti prostovoljne privolitve po poučitvi pred intervencijo.
This Regulation should therefore set clear rules whereby such patients may be enrolled in the clinical trial under very strict conditions.
Ta uredba bi zato morala določiti jasna pravila, po katerih bi bilo take paciente dovoljeno vključiti v klinično preskušanje le pod zelo strogimi pogoji.
In addition, the said clinical trial should relate directly to the 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.
Poleg tega bi moralo biti klinično preskušanje neposredno povezano z zdravstvenim stanjem, zaradi katerega od udeleženca ali njegovega zakonito imenovanega zastopnika v obdobju zdravljenja ni mogoče pridobiti predhodne prostovoljne privolitve po poučitvi.
Any previously expressed objection by the patient should be respected, and informed consent from the subject or from his or her legally designated representative should be sought as soon as possible.
Upoštevati bi bilo treba vsako pacientovo prej izraženo nasprotovanje, prostovoljno privolitev udeleženca ali zakonito imenovanega zastopnika po poučitvi pa bi bilo treba pridobiti čim prej.
In order to allow patients to assess possibilities to participate in a clinical trial, and to allow for effective supervision of a clinical trial by the Member State concerned, the start of the clinical trial, the end of the recruitment of subjects for the clinical trial and the end of the clinical trial should be notified.
Da bi pacienti lahko ocenili možnosti za sodelovanje v kliničnem preskušanju in da se omogoči učinkovito nadziranje kliničnega preskušanja s strani zadevnih držav članic, bi bilo treba začetek kliničnega preskušanja, konec postopka pridobivanja udeležencev za klinično preskušanje in konec kliničnega preskušanja priglasiti.
In accordance with international standards, the results of the clinical trial should be reported within one year from the end of the clinical trial.
V skladu z mednarodnimi standardi bi bilo treba rezultate kliničnega preskušanja razglasiti največ eno leto po koncu kliničnega preskušanja.
The date of the first act of recruitment of a potential subject is the date on which the first act of the recruitment strategy described in the protocol was performed, e. g. the date of a contact with a potential subject or the date of the publication of an advertisement for a particular clinical trial.
Datum prve faze pridobivanja morebitnega udeleženca je datum, ko je zaključena prva faza v skladu s strategijo pridobivanja udeležencev, opisana v protokolu, na primer datum stika s potencialnim udeležencem ali datum objave oglasa za določeno klinično preskušanje.
The sponsor should submit a summary of the results of the clinical trial together with a summary that is understandable to a layperson, and the clinical study report, where applicable, within the defined timelines.
Sponzor bi moral v določenem časovnem okviru predložiti povzetek rezultatov kliničnega preskušanja skupaj s povzetkom, ki je razumljiv nestrokovnjakom, in po potrebi poročilom o klinični študiji.
Where it is not possible to submit the summary of the results within the defined timelines for scientific reasons, for example when the clinical trial is still ongoing in third countries and data from that part of the trial are not available, which makes a statistical analysis not relevant, the sponsor should justify this in the protocol and specify when the results are going to be submitted.
Kadar v določenem časovnem okviru iz znanstvenih razlogov ni mogoče predložiti povzetka rezultatov, na primer, če klinično preskušanje v tretjih državah še poteka in če podatki iz tega dela preskušanja niso na voljo, zaradi česar statistična analiza ni relevantna, bi moral sponzor to v protokolu upravičiti in navesti, kdaj bodo rezultati predloženi.
In order for the sponsor to assess all potentially relevant safety information, the investigator should, as a rule, report to him all serious adverse events.
Raziskovalec bi moral sponzorja praviloma obvestiti o vseh resnih neželenih dogodkih, da bi lahko sponzor ocenil vse informacije o varnosti, ki so morda pomembne.
The sponsor should assess the information received from the investigator, and report safety information on serious adverse events which are suspected unexpected serious adverse reactions to the European Medicines Agency (‘the Agency’).
Sponzor bi moral oceniti informacije, ki jih prejeme od raziskovalca, in o varnostnih informacijah o resnih neželenih dogodkih, pri katerih obstaja sum na nepričakovane resne neželene učinke, obvestiti Evropsko agencijo za zdravila (v nadaljnjem besedilu: Agencija).
The Agency should forward that information to the Member States for them to assess it.
Agencija bi morala te informacije posredovati državam članicam, da jih ocenijo.