natgillin/translations-raw huggingface dataset:
‘Auxiliary medicinal product’ means a medicinal product used for the needs of a clinical trial as described in the protocol, but not as an investigational medicinal product;
„zadevna država članica“ pomeni državo članico, v kateri je bila v skladu s poglavji II oziroma III te uredbe vložena vloga za odobritev kliničnega preskušanja ali bistvene spremembe;
‘Authorised investigational medicinal product’ means a medicinal product authorised in accordance with Regulation (EC) No 726/2004 or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an investigational medicinal product;
„bistvena sprememba“ pomeni vsako spremembo katerega od vidikov kliničnega preskušanja, do katere pride po obvestilu o sklepu iz členov 8, 14, 19, 20 ali 23 in ki lahko bistveno vpliva na varnost ali pravice udeležencev ali na zanesljivost in ponovljivost podatkov iz kliničnega preskušanja;
‘Authorised auxiliary medicinal product’ means a medicinal product authorised in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an auxiliary medicinal product;
„sponzor“ pomeni posameznika, podjetje, ustanovo ali organizacijo, ki prevzame odgovornost za začetek, za vodenje in za pripravo financiranja kliničnega preskušanja;
‘Ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;
„raziskovalec“ pomeni posameznika, odgovornega za izvajanje kliničnega preskušanja na mestu preskušanja;
‘Member State concerned’ means the Member State where an application for authorisation of a clinical trial or of a substantial modification has been submitted under Chapters II or III of this Regulation respectively;
„glavni raziskovalec“ pomeni raziskovalca, ki je odgovoren za vodenje skupine raziskovalcev, ki izvajajo klinično preskušanje na mestu preskušanja;
‘Substantial modification’ means any change to any aspect of the clinical trial which is made after notification of a decision referred to in Articles 8, 14, 19, 20 or 23 and which is likely to 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;
„udeleženec“ pomeni posameznika, ki sodeluje v kliničnem preskušanju kot prejemnik zdravila v preskušanju ali kot član kontrolne skupine;
‘Sponsor’ means an individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial;
„mladoletnik“ pomeni udeleženca, ki v skladu s pravom zadevne države članice še ni pridobil popolne poslovne sposobnosti za dajanje prostovoljne privolitve po poučitvi;
‘Investigator’ means an individual responsible for the conduct of a clinical trial at a clinical trial site;
„nezmožna oseba“ pomeni udeleženca, ki iz drugih razlogov, kot je starost za pravno sposobnost podati prostovoljno privolitev po poučitvi, v skladu s pravom zadevne države članice ni sposoben dati prostovoljne privolitve po poučitvi;
‘Principal investigator’ means an investigator who is the responsible leader of a team of investigators who conduct a clinical trial at a clinical trial site;
„zakonito imenovani zastopnik“ pomeni fizično ali pravno osebo, organ ali telo, ki je v skladu s pravom zadevne države članice pooblaščena za dajanje prostovoljne privolitve po poučitvi v imenu udeleženca, ki je nezmožna oseba ali mladoletnik;
‘Subject’ means an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control;
„prostovoljna privolitev po poučitvi“ pomeni, da udeleženec svobodno in prostovoljno izrazi svojo pripravljenost za sodelovanje v določenem kliničnem preskušanju, potem ko je bil obveščen o vseh vidikih kliničnega preskušanja, ki so pomembni pri njegovi odločitvi za sodelovanje, ali, v primeru mladoletnikov ali nezmožnih oseb, dovoljenje ali soglasje njihovega zakonito imenovanega zastopnika, da se jih vključi v klinično preskušanje;
‘Minor’ means a subject who is, according to the law of the Member State concerned, under the age of legal competence to give informed consent;
„protokol“ pomeni dokument, ki opisuje cilje, načrt, metodologijo, statistično obdelavo in organizacijo kliničnega preskušanja.
‘Incapacitated subject’ means a subject who is, for reasons other than the age of legal competence to give informed consent, incapable of giving informed consent according to the law of the Member State concerned;
Izraz „protokol“ zajema zaporedne verzije protokola in njegove spremembe;
‘Legally designated representative’ means a natural or legal person, authority or body which, according to the law of the Member State concerned, is empowered to give informed consent on behalf of a subject who is an incapacitated subject or a minor;
„brošura za raziskovalca“ pomeni zbir kliničnih in nekliničnih podatkov o zdravilu ali zdravilih v preskušanju, ki so pomembni za raziskovanje zdravila ali zdravil pri ljudeh;
‘Informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject's decision to participate or, in case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical trial;
„proizvodnja“ pomeni celotno in delno proizvodnjo ter različne postopke delitve zdravila na manjše enote, pakiranje in označevanje (vključno z zakrivanjem);
‘Protocol’ means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial.
„začetek kliničnega preskušanja“ pomeni prvo fazo pridobivanja morebitnega udeleženca za določeno klinično preskušanje, razen če ni v protokolu določeno drugače;
The term ‘protocol’ encompasses successive versions of the protocol and protocol modifications;
„konec kliničnega preskušanja“ pomeni zadnji obisk zadnjega udeleženca ali pozneje, kot je določeno v protokolu;
‘Investigator's brochure’ means a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in humans;
„predčasna ustavitev kliničnega preskušanja“ pomeni prezgodnji konec kliničnega preskušanja iz katerega koli razloga, preden so izpolnjeni pogoji, navedeni v protokolu;
‘Manufacturing’ means total and partial manufacture, as well as the various processes of dividing up, packaging and labelling (including blinding);
„začasna ustavitev kliničnega preskušanja“ pomeni prekinitev izvajanja kliničnega preskušanja, ki ni določena v protokolu, s strani sponzorja, ki ga sponzor namerava nadaljevati;
‘Start of a clinical trial’ means the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol;
„odložitev kliničnega preskušanja“ pomeni prekinitev izvajanja kliničnega preskušanja s strani države članice;
‘End of a clinical trial’ means the last visit of the last subject, or at a later point in time as defined in the protocol;
„dobra klinična praksa“ pomeni sklop podrobnih etičnih in znanstvenih zahtev glede kakovosti za načrtovanje, vodenje, izvajanje, spremljanje, preverjanje, evidentiranje, analizo kliničnih preskušanj in poročanje o njih, ki zagotavljajo zaščito pravic udeležencev, njihovo varnost in dobrobit ter zanesljivost in ponovljivost podatkov iz kliničnih preskušanj;
‘Early termination of a clinical trial’ means the premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with;
„pregled“ pomeni dejanje, ki ga opravi organ, pristojen za uradni pregled dokumentov, prostorov, evidenc, sistemov za zagotavljanje kakovosti in drugih virov, za katere pristojni organ meni, da so povezani s kliničnim preskušanjem, in ki se lahko nahajajo na mestu preskušanja, v prostorih sponzorja in/ali pogodbene raziskovalne organizacije ali v drugih ustanovah, za katere pristojni organ presodi, da jih je ustrezno pregledati;
‘Temporary halt of a clinical trial’ means an interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it;
„neželen dogodek“ pomeni kakršen koli neugoden medicinski pojav, ki ni nujno vzročno povezan s tem zdravljenjem, pri udeležencu, ki je dobil zdravilo;
‘Suspension of a clinical trial’ means interruption of the conduct of a clinical trial by a Member State;
„resen neželen dogodek“ pomeni vsak neugoden medicinski pojav, ki pri katerem koli odmerku zahteva bolnišnično zdravljenje ali podaljšanje bolnišničnega zdravljenja, povzroči trajno ali izrazito invalidnost ali nezmožnost, prirojeno anomalijo ali motnjo ter neposredno življenjsko ogroženost ali smrt;
‘Good clinical practice’ means a set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust;
„nepričakovan resen neželen učinek“ pomeni resen neželen učinek, katerega vrsta, resnost ali izid ni v skladu z referenčnimi informacijami o varnosti;
‘Inspection’ means the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the clinical trial site, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect;
„poročilo o klinični študiji“ pomeni poročilo o kliničnem preskušanju v obliki, ki omogoča enostavno iskanje, pripravljeno v skladu z modulom 5 dela I Priloge I Direktive 2001/83/ES in ki je priloženo vlogi za dovoljenje za promet.
‘Adverse event’ means any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment;
V tej uredbi se udeleženec, ki spada tako v opredelitev pojma „mladoletnik“ kot „nezmožna oseba“, šteje za nezmožno osebo.
‘Serious adverse event’ means any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death;
Člen 3
‘Unexpected serious adverse reaction’ means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information;
Splošno načelo
‘Clinical study report’ means a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation.
Klinično preskušanje se lahko izvaja le, če:
For the purposes of this Regulation, a subject who falls under the definition of both ‘minor’ and ‘incapacitated subject’ shall be deemed to be an incapacitated subject.
so zaščitene pravice, varnost, dostojanstvo in dobrobit udeležencev, ki prevladajo nad vsemi drugimi interesi, ter
Article 3
je zasnovano tako, da bo dalo zanesljive in ponovljive podatke.
General principle
POGLAVJE II
A clinical trial may be conducted only if:
POSTOPEK ODOBRITVE KLINIČNEGA PRESKUŠANJA
the rights, safety, dignity and well-being of subjects are protected and prevail over all other interests; and
Člen 4
it is designed to generate reliable and robust data.
Predhodna odobritev
CHAPTER II
Za klinično preskušanje je potreben znanstveni in etični pregled in se odobri v skladu s to uredbo.
AUTHORISATION PROCEDURE FOR A CLINICAL TRIAL
Etični pregled opravi etični odbor v skladu s pravom zadevne države članice, v kateri je ustanovljen.
Article 4
Pregled etičnega odbora lahko zajema vidike iz dela I poročila o oceni za odobritev kliničnega preskušanja iz člena 6 in dela II navedenega poročila o oceni iz člena 7, kot je ustrezno za posamezno zadevno državo članico.
Prior authorisation
Države članice zagotovijo, da so obdobje in postopki za pregled etičnega odbora skladni z obdobjem in postopki iz te uredbe za oceno vloge za odobritev kliničnega preskušanja.
A clinical trial shall be subject to scientific and ethical review and shall be authorised in accordance with this Regulation.
Člen 5
The ethical review shall be performed by an ethics committee in accordance with the law of the Member State concerned.
Predložitev vloge
The review by the ethics committee may encompass aspects addressed in Part I of the assessment report for the authorisation of a clinical trial as referred to in Article 6 and in Part II of that assessment report as referred to in Article 7 as appropriate for each Member State concerned.
Za pridobitev odobritve sponzor predloži dosje vloge zadevni državi članici prek portala iz člena 80 (v nadaljnjem besedilu: portal EU).
Member States shall ensure that the timelines and procedures for the review by the ethics committees are compatible with the timelines and procedures set out in this Regulation for the assessment of the application for authorisation of a clinical trial.
Sponzor kot državo članico poročevalko predlaga eno od zadevnih držav članic.
Article 5
Če je zadevna država članica, ki ni predlagana država članica poročevalka, pripravljena biti država članica poročevalka ali če predlagana država članica poročevalka ne želi biti poročevalka, se o tem uradno obvestijo vse zadevne države članice najpozneje tri dni po predložitvi dosjeja vloge prek portala EU.
Submission of an application
Če je samo ena zadevna država članica pripravljena biti država članica poročevalka ali če je pri kliničnem preskušanju udeležena samo ena država članica, je ta država članica država članica poročevalka.
In order to obtain an authorisation, the sponsor shall submit an application dossier to the intended Member States concerned through the portal referred to in Article 80 (the ‘EU portal’).
Če nobena zadevna država članica ni pripravljena biti država članica poročevalka ali če je več zadevnih držav članic, ki so pripravljene biti poročevalke, se državo članico poročevalko izbere na podlagi dogovora med zadevnimi državami članicami, upoštevajoč priporočila iz točke (c) člena 85(2).
The sponsor shall propose one of the Member States concerned as reporting Member State.
Če zadevne države članice ne dosežejo soglasja, je država članica poročevalka predlagana država članica poročevalka.
If a Member State concerned other than the proposed reporting Member State is willing to be the reporting Member State or where the proposed reporting Member State does not wish to be the reporting Member State, this shall be notified through the EU portal to all Member States concerned not later than three days after the application dossier is submitted.
Država članica poročevalka v šestih dneh po predložitvi dosjeja vloge uradno prek portala EU obvesti sponzorja in druge zadevne države članice o tem, da je država članica poročevalka.
If only one Member State concerned is willing to be the reporting Member State or if the clinical trial involves only one Member State, that Member State shall be the reporting Member State.
V primeru vloge za klinično preskušanje z minimalno intervencijo, pri katerem se zdravilo v preskušanju ne uporablja v skladu s pogoji dovoljenja za promet, temveč uporaba tega zdravila temelji na dokazih in je podprta z objavljenimi znanstvenimi dokazi o varnosti in učinkovitosti tega zdravila, sponzor za državo članico poročevalko predlaga eno izmed zadevnih držav članic, v kateri uporaba temelji na dokazih.
If there is no Member State concerned willing to be the reporting Member State or if there is more than one Member State concerned willing to be the reporting Member State, the reporting Member State shall be selected by agreement among the Member States concerned taking into account the recommendations referred to in point (c) of Article 85(2).
V desetih dneh po predložitvi dosjeja vloge država članica poročevalka potrdi vlogo, pri čemer upošteva pomisleke druge zadevne države članice, ter prek portala EU obvesti sponzorja o naslednjem:
If there is no agreement among the Member States concerned, the proposed reporting Member State shall be the reporting Member State.
ali spada klinično preskušanje, za katero je vloga predložena, v področje uporabe te uredbe;
The reporting Member State shall notify the sponsor and the other Member States concerned that it is the reporting Member State, through the EU portal, within six days from the submission of the application dossier.
ali je dosje vloge popoln v skladu s Prilogo I.
The sponsor shall, when applying for a low-intervention clinical trial, where the investigational medicinal product is not used in accordance with the terms of the marketing authorisation but the use of that product is evidence-based and supported by published scientific evidence on the safety and efficacy of that product, propose one of the Member States concerned where the use is evidence-based, as reporting Member State.
Zadevna država članica lahko državi članici poročevalki sporoči vse pomisleke v zvezi s potrditvijo vloge v sedmih dneh po predložitvi dosjeja vloge.
Within 10 days from the submission of the application dossier, the reporting Member State shall validate the application taking into account considerations expressed by the other Member States concerned and notify the sponsor, through the EU portal, of the following:
Kadar država članica poročevalka sponzorja v roku iz prvega pododstavka odstavka 3 ni obvestila, se šteje, da spada klinično preskušanje, za katero je vloga predložena, v področje uporabe te uredbe in se dosje vloge šteje za popolnega.
whether the clinical trial applied for falls within the scope of this Regulation;
Kadar država članica poročevalka ob upoštevanju pomislekov, ki jih izrazi zadevna druga država članica, meni, da dosje vloge ni popoln ali da klinično preskušanje, za katero je vloga predložena, ne spada na področje uporabe te uredbe, o tem obvesti sponzorja prek portala EU ter mu da na voljo največ deset dni za pripombe na vlogo ali dopolnitev dosjeja vloge prek portala EU.
whether the application dossier is complete in accordance with Annex I;
Država članica poročevalka v petih dneh po prejemu pripomb ali popolnega dosjeja vloge sponzorja obvesti, ali je vloga skladna z zahtevami iz točk (b) in (c) prvega pododstavka odstavka 3.
Member States concerned may communicate to the reporting Member State any considerations relevant to the validation of the application within seven days from the submission of the application dossier.
Kadar država članica poročevalka sponzorja v roku iz drugega pododstavka ni obvestila, se šteje, da spada klinično preskušanje, za katerega je vloga predložena, v področje uporabe te uredbe in šteje se, da je dosje vloge popoln.
Where the reporting Member State has not notified the sponsor within the period referred to in the first subparagraph of paragraph 3, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
Kadar sponzor ni predložil pripomb in ni dopolnil dosjeja vloge v roku iz prvega pododstavka, se šteje, da je vloga v vseh zadevnih državah članicah zapadla.
Where the reporting Member State, taking into account considerations expressed by the other Member States concerned, finds that the application dossier is not complete, or that the clinical trial applied for does not fall within the scope of this Regulation, it shall inform the sponsor thereof through the EU portal and shall set a maximum of 10 days for the sponsor to comment on the application or to complete the application dossier through the EU portal.
Za namene tega poglavja se dan, ko je sponzor obveščen v skladu z odstavkom 3 ali 5, šteje za datum potrditve vloge.
Within five days from receipt of the comments or the completed application dossier, the reporting Member State shall notify the sponsor as to whether or not the application complies with the requirements set out in points (a) and (b) of the first subparagraph of paragraph 3.
Kadar sponzor ni obveščen, se za datum potrditve šteje zadnji dan ustreznih rokov iz odstavkov 3 in 5.
Where the reporting Member State has not notified the sponsor within the period referred to in the second subparagraph, the clinical trial applied for shall be deemed to fall within the scope of this Regulation and the application dossier shall be considered complete.
Člen 6
Where the sponsor has not provided comments or completed the application dossier within the period referred to in the first subparagraph, the application shall be deemed to have lapsed in all Member States concerned.
Poročilo o oceni – vidiki, zajeti v delu I
For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 3 or 5 shall be the validation date of the application.
Država članica poročevalka oceni vlogo glede na naslednje vidike:
Where the sponsor is not notified, the validation date shall be the last day of the respective periods referred to in paragraphs 3 and 5.
ali gre dejansko za klinično preskušanje z minimalno intervencijo, kadar tako trdi sponzor;
Article 6
skladnost s poglavjem V glede:
Assessment report — Aspects covered by Part I
pričakovanih koristi pri zdravljenju in koristi za javno zdravje, pri čemer se upoštevajo:
The reporting Member State shall assess the application with regard to the following aspects:
značilnosti zdravil v preskušanju in vedenje o njih,
Whether the clinical trial is a low-intervention clinical trial, where claimed by the sponsor;
pomen kliničnega preskušanja, vključno s tem, ali skupine udeležencev, ki sodelujejo v kliničnem preskušanju, predstavljajo populacijo, ki bo zdravljena, oziroma če ne, obrazložitev in utemeljitev, zagotovljeni v skladu s točko (y) odstavka 17 Priloge I k tej uredbi; trenutna znanstvena spoznanja; dejstva, ali so klinično preskušanje priporočili ali zahtevali regulatorni organi, pristojni za ocenjevanje in izdajo dovoljenj za promet z zdravili; ter, po potrebi, mnenje Odbora za pediatrijo o načrtu pediatričnih raziskav v skladu z Uredbo (ES) št. 1901/2006 Evropskega parlamenta in Sveta [12],zanesljivost in ponovljivost podatkov iz kliničnega preskušanja ob upoštevanju statistične obdelave, načrtovanja kliničnega preskušanja in metodologije, vključno z velikostjo vzorca in randomizacijo, primerjalnim zdravilom in merili učinkovitosti,
Compliance with Chapter V with respect to the following:
tveganj in neprijetnosti za udeleženca, pri čemer se upoštevajo:
The anticipated therapeutic and public health benefits taking account of all of the following:
značilnosti zdravil v preskušanju in pomožnih zdravil ter vedenje o njih,
the characteristics of and knowledge about the investigational medicinal products;
značilnosti intervencije v primerjavi z običajno klinično prakso,