natgillin/translations-raw huggingface dataset:
Decision Atalanta/2/2013 is hereby repealed.
Sklep Atalanta/2/2013 se razveljavi.
This Decision shall enter into force on 6 December 2013.
Ta sklep začne veljati 6. decembra 2013.
Political and Security Committee Decision Atalanta/2/2013 of 2 July 2013 on the appointment of an EU Force Commander for the European Union military operation to contribute to the deterrence, prevention and repression of acts of piracy and armed robbery off the Somali coast (Atalanta) (OJ L 187, 6.7.2013, p. 8).
Sklep Političnega in varnostnega odbora Atalanta/2/2013 z dne 2. julija 2013 o imenovanju poveljnika sil EU v vojaški operaciji Evropske unije kot prispevku k odvračanju, preprečevanju in zatiranju piratstva in oboroženih ropov pred somalsko obalo (Atalanta) (UL L 187, 6.7.2013, str. 8).
on setting up the European Clinical Research Infrastructure Network (ECRIN) as a European Research Infrastructure Consortium (ECRIN-ERIC)
o ustanovitvi Evropske mreže klinične raziskovalne infrastrukture (ECRIN) kot Konzorcija evropske raziskovalne infrastrukture (ECRIN-ERIC)
The Federal Republic of Germany, the Kingdom of Spain, the French Republic, the Italian Republic and the Portuguese Republic requested the Commission to set up the the European Clinical Research Infrastructure Network (ECRIN) as a European Research Infrastructure Consortium (ECRIN-ERIC).
Zvezna republika Nemčija, Kraljevina Španija, Francoska republika, Italijanska republika in Portugalska republika so od Komisije zahtevale, da ustanovi Evropsko mrežo klinične raziskovalne infrastrukture (ECRIN) kot Konzorcij evropske raziskovalne infrastrukture (ECRIN-ERIC).
The French Republic has been chosen by the Federal Republic of Germany, the Kingdom of Spain, the Italian Republic and the Portuguese Republic as the Host Member State of ECRIN-ERIC.
Zvezna republika Nemčija, Kraljevina Španija, Italijanska republika in Portugalska republika so kot državo članico gostiteljico ECRIN-ERIC izbrale Francosko republiko.
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 20 of Regulation (EC) No 723/2009,
Ukrepi iz tega sklepa so v skladu z mnenjem Odbora, ustanovljenega s členom 20 Uredbe (ES) št. 723/2009 –
The European Clinical Research Infrastructure Network as a European Research Infrastructure Consortium named ECRIN-ERIC is hereby established.
Ustanovi se Evropska mreža klinične raziskovalne infrastrukture kot Konzorcij evropske raziskovalne infrastrukture, ki se imenuje ECRIN-ERIC.
The Statutes of ECRIN-ERIC are set out in the Annex.
Statut ECRIN-ERIC je določen v Prilogi.
These Statutes shall be kept up to date and made publicly available on the website of ECRIN-ERIC and at its statutory seat.
Ta statut se posodablja ter je javno dostopen na spletišču in uradnem sedežu ECRIN-ERIC.
The essential elements of the ECRIN-ERIC Statutes for which amendments shall require approval by the Commission in accordance with Article 11(1) of Regulation (EC) No 723/2009 are provided for in Articles 1, 2, 3, 11, 12, 14, 15, 19 and 20.
Bistveni elementi statuta ECRIN-ERIC, katerega spremembe odobri Komisija v skladu s členom 11(1) Uredbe (ES) št. 723/2009, so določeni v členih 1, 2, 3, 11, 12, 14, 15, 19 in 20.
This Decision shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
Ta sklep začne veljati tretji dan po njegovi objavi v Uradnem listu Evropske unije.
STATUTES OF THE EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (ECRIN-ERIC)
STATUT EVROPSKE MREŽE KLINIČNE RAZISKOVALNE INFRASTRUKTURE (ECRIN-ERIC)
THE FEDERAL REPUBLIC OF GERMANY
ZVEZNA REPUBLIKA NEMČIJA,
THE KINGDOM OF SPAIN
KRALJEVINA ŠPANIJA,
THE FRENCH REPUBLIC
FRANCOSKA REPUBLIKA,
THE ITALIAN REPUBLIC
ITALIJANSKA REPUBLIKA,
Hereinafter referred to as ‘the Founding Members’
v nadaljnjem besedilu: ustanovitvene članice –
DESIRING to strengthen Europe’s and the Founding Member countries’ position in clinical research in the world, and to intensify cooperation across national boundaries;
V ŽELJI okrepiti položaj Evrope in ustanovitvenih držav članic na področju kliničnih raziskav v svetu ter poglobiti sodelovanje prek nacionalnih meja,
CONSIDERING that multinational clinical research is currently hampered by the fragmentation of health and legislative systems in Europe, an obstacle for multinational cooperation in investigator driven, as well as industry-sponsored clinical research (particularly in the biotechnology and medical device sectors), European countries must unlock latent scientific potential and access to patients and expertise, thus strengthening the competitiveness of Europe in clinical science and its attractiveness for the development of preventive, diagnostic and therapeutic procedures — this is of particular importance for rare diseases, paediatrics, personalised treatments, for the development of biotherapy, and for independent clinical trials that are pivotal instruments for evidence-based medicine;
KER večnacionalne klinične raziskave trenutno omejuje razdrobljenost zdravstvenih in zakonodajnih sistemov v Evropi, kar ovira večnacionalno sodelovanje v kliničnih raziskavah, ki se izvajajo na pobudo raziskovalcev in jih sponzorira industrija (zlasti v sektorju biotehnologije in medicinskih pripomočkov), morajo evropske države sprostiti mirujoč znanstveni potencial in dostop za paciente ter strokovno znanje in izkušnje, s tem pa povečati konkurenčnost Evrope v klinični znanosti in njeno privlačnost za razvoj preventivnih, diagnostičnih in terapevtskih postopkov, kar je zlasti pomembno pri redkih obolenjih, pediatriji, posamezniku prilagojenem zdravljenju, za razvoj bioterapije in neodvisna klinična preskušanja, ki so ključni instrumenti z dokazi podprte medicine,
BUILDING on the ESFRI roadmap that identified the European Clinical Research Infrastructure Network (ECRIN) as the distributed infrastructure supporting, based on scientific excellence, clinical research in Europe through information, consulting and services to investigators and sponsors in multinational studies, acting through correspondents hosted in national clinical research hubs and networks, also contributing to the structuring of national infrastructures, harmonising training, tools and practice and high quality standards, fostering transparency and data sharing, promoting a harmonised regulatory system and shared ethical standards;
NA PODLAGI načrta ESFRI, ki je opredelil Evropsko mrežo klinične raziskovalne infrastrukture (ECRIN) kot razpršeno infrastrukturo, ki na podlagi znanstvene odličnosti podpira klinične raziskave v Evropi z informacijami, svetovanjem in storitvami za raziskovalce in sponzorje pri večnacionalnih študijah, pri tem pa deluje prek korespondentov, ki gostujejo v nacionalnih kliničnih raziskovalnih središčih in mrežah, in hkrati prispeva k strukturiranju nacionalnih infrastruktur, usklajevanju usposabljanja, orodij in prakse ter standardov visoke kakovosti, spodbuja preglednost in izmenjavo podatkov, podpira usklajen regulativni sistem in skupne etične standarde,
RECOGNISING that, for each Member country, participating in ECRIN enables the initiation of, and the participation in multinational clinical research projects, taking advantage of the population size of the European Union, therefore strengthens the attractiveness and competitiveness of the national clinical research infrastructure and its ability to support high quality clinical research in line with European standards, with a strong impact on research capacity, on innovation, and on health;
V SPOZNANJU, da sodelovanje v ECRIN vsaki državi članici omogoča začetek izvajanja večnacionalnih kliničnih raziskovalnih projektov in udeležbo v njih ob upoštevanju števila prebivalstva Evropske unije, s tem pa povečuje privlačnost in konkurenčnost nacionalne klinične raziskovalne infrastrukture ter njeno zmožnost podpiranja kliničnih raziskav visoke kakovosti v skladu z evropskimi standardi, z močnim vplivom na raziskovalno zmogljivost, inovacije in zdravje,
Establishment of ECRIN-ERIC
Ustanovitev ECRIN-ERIC
There shall be a distributed European Research Infrastructure called the European Clinical Research Infrastructure Network (ECRIN).
Ustanovi se razpršena evropska raziskovalna infrastruktura, ki se imenuje Evropska mreža klinične raziskovalne infrastrukture (ECRIN).
The name of the European Research Infrastructure Consortium (ERIC) - European Clinical Research Infrastructure Network shall be ‘ECRIN-ERIC’.
Konzorcij evropske raziskovalne infrastrukture (ERIC) za Evropsko mrežo klinične raziskovalne infrastrukture se imenuje „ECRIN-ERIC“.
ECRIN-ERIC shall constitute a Pan-European distributed clinical research infrastructure with as objectives to provide advice and services to multinational clinical research, in any medical field and for any category of clinical research, observing high scientific, ethical and quality standards, in order to strengthen the capacity of the European Union to explore the determinants of diseases and to develop and optimise the use of diagnostic, prevention and treatment strategies.
ECRIN-ERIC je del vseevropske razpršene klinične raziskovalne infrastrukture, katere cilj je zagotavljati nasvete in storitve za večnacionalne klinične raziskave na katerem koli medicinskem področju in za katero koli kategorijo kliničnih raziskav ob upoštevanju visokih znanstvenih, etičnih in kakovostnih standardov, da bi se povečala zmogljivost Evropske unije pri raziskovanju determinant bolezni ter razvila in optimizirala uporaba strategij za diagnosticiranje, preprečevanje in zdravljenje.
provide support to multicentre clinical studies involving at least two countries;
zagotavlja podporo multicentričnim kliničnim študijam, v katere sta vključeni najmanj dve državi;
be primarily accessible to investigator-initiated clinical research, but also open to industry sponsored clinical research projects, originating from any country;
je zlasti dostopen za klinične raziskave, ki se izvajajo na pobudo raziskovalcev, a tudi klinične raziskovalne projekte iz katere koli države, ki jih sponzorira industrija;
encourage cooperation and harmonisation;
spodbuja sodelovanje in usklajevanje;
be a distributed infrastructure, based on the connection of existing national or regional clinical research networks;
je razpršena infrastruktura, ki temelji na povezavi obstoječih nacionalnih ali regionalnih kliničnih raziskovalnih mrež;
promote common standards, tools and practice that will impact on the structuring of national networks;
spodbuja skupne standarde, orodja in prakse, ki bodo vplivali na strukturiranje nacionalnih mrež;
promote training of investigators and all categories of professionals and lay persons involved in clinical research;
spodbuja usposabljanje raziskovalcev in vseh kategorij strokovnjakov ter nestrokovnjakov, vključenih v klinične raziskave;
promote quality, transparency and optimal use of clinical research data;
podpira kakovost, preglednost in najboljšo uporabo podatkov kliničnih raziskav;
communicate with patients and citizens on the challenges and opportunities raised by clinical research.
obvešča paciente in državljane o izzivih in priložnostih, ki jih nudijo klinične raziskave.
The principal task of ECRIN-ERIC shall be to establish and operate a research infrastructure supporting multinational collaboration in clinical research, to make Europe a single area for clinical trials.
Glavna naloga ECRIN-ERIC je vzpostaviti in upravljati raziskovalno infrastrukturo, ki podpira večnacionalno sodelovanje v kliničnih raziskavah, da bi Evropa postala enoten prostor za klinična preskušanja.
ECRIN-ERIC shall provide information, advice and services to clinical investigators and sponsors of multinational studies, as well as advice to national and European authorities and policymakers, as described in the Scientific and Technical Annex accompanying the ERIC application documents.
ECRIN-ERIC zagotavlja informacije, nasvete in storitve kliničnim raziskovalcem in sponzorjem večnacionalnih študij ter svetuje nacionalnim in evropskim organom ter oblikovalcem politik, kot je opisano v znanstveni in tehnični prilogi, ki je priložena vlogi za ustanovitev ERIC.
Information, advice and services proposed by ECRIN-ERIC shall particularly cover support to clinical trial management, reducing the fragmentation of health and legislative systems in Europe: submissions to ethics committees and competent authorities, adverse event reporting, study monitoring, data management, support with insurance contracting.
Informacije, nasveti in storitve, ki jih predlaga ECRIN-ERIC, zlasti zajemajo podporo za upravljanje kliničnega preskušanja, s čimer se zmanjšuje razdrobljenost zdravstvenih in zakonodajnih sistemov v Evropi, in sicer dopise etičnim odborom in pristojnim organom, poročanje o neželenih dogodkih, spremljanje študij, upravljanje s podatki, podporo pri sklepanju zavarovalnih pogodb.
ECRIN-ERIC shall pursue its principal task on a non-economic basis.
ECRIN-ERIC opravlja svojo glavno nalogo na negospodarski podlagi.
However it may carry out limited economic activities, provided that these are closely related to its principal task and that do not jeopardise the achievement thereof.
Kljub temu lahko opravlja nekatere gospodarske dejavnosti, pod pogojem, da so tesno povezane z njegovo glavno nalogo in ne ogrožajo izvajanja le-te.
ECRIN-ERIC shall record the costs and revenues of the economic activities referred to in paragraph 4 separately and shall charge market prices for them, or if these cannot be ascertained, full costs plus reasonable margin.
ECRIN-ERIC ločeno beleži odhodke in prihodke svojih gospodarskih dejavnosti, navedenih v odstavku 4, ter zaračuna tržne cene zanje ali, če teh ni mogoče določiti, polno ceno z razumno maržo.
The following entities may become Member or Observer of ECRIN-ERIC:
Članice ali opazovalke ECRIN-ERIC lahko postanejo naslednji subjekti:
Associate Countries;
pridružene države;
Third Countries other than Associate Countries; and
tretje države, ki niso pridružene države, in
Intergovernmental Organisations.
medvladne organizacije.
ECRIN-ERIC shall have at least three Member States as Members.
V ECRIN-ERIC so včlanjene vsaj tri države članice.
Members of ECRIN–ERIC of which membership commenced with the ECRIN-ERIC foundation will be hereinafter referred to as Founding Members.
Članice ECRIN-ERIN, katerih članstvo se je začelo z ustanovitvijo ECRIN-ERIC, so v nadaljnjem besedilu imenovane ustanovitvene članice.
European Union Member States shall hold jointly the majority of voting rights in the Assembly of Members.
Države članice Evropske unije imajo skupaj večino glasov v skupščini članic.
The admission of candidate Members, or candidate Observers, shall be subject to the approval of the Assembly of Members.
Včlanitev kandidatk za članstvo ali kandidatk za opazovalko odobri skupščina članic.
Members and Observers of ECRIN-ERIC are listed in Annex II.
Članice in opazovalke ECRIN-ERIC so navedene v Prilogi II.
This Annex shall be updated by the ECRIN-ERIC Director-General after revocation or withdrawal of memberships, or approval of candidate Members or Observers by the Assembly of Members.
To prilogo posodobi generalni direktor ECRIN-ERIC po preklicu članstva ali izstopu iz članstva ali po odobritvi kandidatk za članstvo ali kandidatk za opazovalko s strani skupščine članic.
Withdrawal from Membership
Izstop iz članstva
Members may, by giving a minimum of three years’ notice, withdraw from ECRIN-ERIC by writing to the Chair of the Assembly of Members stating: (1) the reasons for withdrawal and (2) the requested date of withdrawal.
Članice lahko izstopijo iz ECRIN-ERIC na podlagi pisnega obvestila, ki ga predsedniku skupščine članic posredujejo vsaj tri leta prej in v katerem navedejo: (1) razloge za izstop in (2) zahtevani datum izstopa.
All outstanding payments and obligations must be paid and fulfilled before the withdrawal of membership can become effective.
Preden lahko izstop iz članstva začne veljati, je treba plačati in izpolniti vsa neporavnana plačila in obveznosti.
The Assembly of Members shall be notified of any request for withdrawal during the next meeting and the Membership shall be put on hold on that date.
Skupščina članic se o vseh zahtevah za izstop obvesti na naslednji seji, članstvo pa se z navedenim datumom začasno ustavi.
The provisions set out in point (a) in the present paragraph apply also for the withdrawal of Observers, but with a minimum of one year’s notice.
Določbe iz točke (a) tega odstavka veljajo tudi za izstop opazovalk, vendar z obvestilom, ki se posreduje vsaj eno leto pred izstopom.
Revoking Membership
Preklic članstva
The Assembly of Members may revoke the membership of a Member if the following conditions are met:
Skupščina članic lahko prekliče članstvo članice, če so izpolnjeni naslednji pogoji:
the Assembly of Members considers that the Member is in substantial breach, of one or more of its obligations under these Statutes or that the Member brings ECRIN-ERIC into disrepute, and the Member has failed to rectify such breach within 30 days after it has received notice of the breach by the Director-General in writing; or
skupščina članic meni, da članica resno krši eno ali več svojih obveznosti iz tega statuta ali škoduje ugledu ECRIN-ERIC in ni odpravila take kršitve v 30 dneh po prejemu pisnega obvestila generalnega direktorja o kršitvi, ali
the Chair of the Assembly of Members or the Director-General has submitted to the Assembly of Members a motion to revoke the relevant Membership; and
predsednik skupščine članic ali generalni direktor je skupščini članic predložil predlog za preklic zadevnega članstva in
the motion for revocation receives the consent from two thirds of the voting members representing two thirds of the contributions, excluding the Member concerned.
s predlogom za preklic se strinjata dve tretjini članic z glasovalno pravico, ki prispevajo dve tretjini prispevkov, pri čemer je zadevna članica izvzeta.
The provisions set out in point (a) shall apply also for the revocation of Observers.
Določbe iz točke (a) veljajo tudi za preklic članstva opazovalk.
Rights of Members and Observers
Pravice članic in opazovalk
Members shall make full contribution to ECRIN-ERIC as specified in Annex III(4) and according to the pluri-annual workplan and the relative indicative contribution.
Članice polno prispevajo k ECRIN-ERIN, kot je določeno v Prilogi III(4) in je v skladu z večletnim delovnim načrtom in relativnim okvirnim prispevkom.
Observers shall make a partial contribution to ECRIN-ERIC budget for sustainable operation of ECRIN-ERIC as specified in the Annex III(5) and may remain as Observer of ECRIN-ERIC for a maximum period of three years; after this period the Observer has to either apply for Membership or withdraw from ECRIN-ERIC.
Opazovalke delno prispevajo k proračunu ECRIN-ERIC za trajnostno delovanje ECRIN-ERIC, kot je določeno v Prilogi III(5), in lahko ostanejo opazovalke ECRIN-ERIC največ tri leta; po tem obdobju mora opazovalka bodisi zaprositi za članstvo bodisi izstopiti iz ECRIN-ERIC.
Observers shall attend the meeting of the Assembly of Members without voting rights.
Opazovalke se udeležujejo sej skupščine članic, pri čemer nimajo glasovalnih pravic.
Members and Observers may be represented by an appointed body delegate as regards the exercise of specified rights and the discharge of specified obligations as a Member or Observer of ECRIN-ERIC.
Članice in opazovalke lahko v zvezi z izvajanjem navedenih pravic in razrešitvijo navedenih obveznosti kot članica ali opazovalka ECRIN-ERIC zastopa pooblaščenec imenovanega organa.
Members and Observers shall ensure that their delegates comply with the rules, obligations and agreements governing their membership or status as Observer of ECRIN-ERIC as provided under these Statutes.
Članice in opazovalke zagotovijo, da njihovi pooblaščenci upoštevajo pravila, obveznosti in dogovore, ki urejajo njihovo članstvo ali status opazovalke ECRIN-ERIC, kot določa ta statut.
In order to fulfil its role as a distributed European infrastructure, ECRIN-ERIC shall establish links with partners offering centralised or distributed services to ECRIN-ERIC.
ECRIN-ERIC se za izpolnjevanje svoje naloge kot razpršena evropska infrastruktura povezuje s partnerji, ki ECRIN-ERIC zagotavljajo centralizirane ali razpršene storitve.
Such partnerships shall be based on permanent contracts including provisions on the delivery of services and on the quality assurance.
Taka partnerstva temeljijo na pogodbah za nedoločen čas, vključno z določbami o dobavi storitev in zagotavljanju kakovosti.
Scientific Partners
Znanstveni partnerji
Scientific Partners are National Clinical Research Networks that:
Znanstveni partnerji so nacionalne klinične raziskovalne mreže, ki:
are composed of academic clinical research centres or clinical trials units with a national coordinating centre, or a coordination of disease-oriented networks;
jih sestavljajo akademski centri za klinične raziskave ali enote za klinična preskušanja z nacionalnim usklajevalnim centrom ali so sestavljeni na podlagi usklajevanja raziskovalnih mrež na področju bolezni;
have developed shared tools, procedures and practices to facilitate multi-centre studies, have reached the critical mass and represent the standard in the country;
so razvile skupna orodja, postopke in prakse za spodbujanje multicentričnih študij, dosegle kritično maso in pomenijo standard v državi;
are able to provide support to investigators and sponsors for any category of clinical research, in any disease area.
lahko zagotovijo podporo raziskovalcem in sponzorjem za vsako kategorijo kliničnih raziskav na katerem koli področju bolezni.
The following entities may become Scientific Partners of ECRIN-ERIC:
Znanstveni partnerji ECRIN-ERIC lahko postanejo naslednji subjekti:
National Clinical Research Networks proposed by Members of ECRIN-ERIC;
nacionalne klinične raziskovalne mreže, ki jih predlagajo članice ECRIN-ERIC;
National Clinical Research Networks proposed by Observers of ECRIN-ERIC;
nacionalne klinične raziskovalne mreže, ki jih predlagajo opazovalke ECRIN-ERIC;
National Clinical Research Networks of any other EU Member or associated country, neither Member nor Observer of ECRIN-ERIC that provide a contribution as described in point 6 of Annex III;
nacionalne klinične raziskovalne mreže katere koli druge države članice EU ali pridružene države, ki ni niti članica niti opazovalka ECRIN-ERIC in ki zagotavlja prispevke, kot določa točka 6 Priloge III;
National Clinical Research Networks of third countries, neither Member nor Observer of ECRIN-ERIC, that provide a contribution as described in point 6 of Annex III.
nacionalne klinične raziskovalne mreže tretjih držav, ki niso niti članice niti opazovalke ECRIN-ERIC in ki zagotavljajo prispevke, kot določa točka 6 Priloge III.
The Assembly of Members shall define the rules and conditions for establishing scientific partnerships with candidate Scientific Partners.
Skupščina članic opredeli pravila in pogoje za vzpostavitev znanstvenega partnerstva s kandidatom za znanstvenega partnerja.
The rights and obligations governing the scientific partnership shall be set out in the Internal Rules of Procedure that shall be adopted by the Assembly of Members on proposal by the ECRIN-ERIC Director-General.
Pravice in obveznosti, ki urejajo znanstveno partnerstvo, so določene v notranjem poslovniku, ki ga na predlog generalnega direktorja ECRIN-ERIC sprejme skupščina članic.
Scientific Partners shall assign a Senior Scientist that represents the National Clinical Research Network in the Network Committee as provided for under Article 9(1) of the present Statutes.
Znanstveni partnerji določijo višjega znanstvenika, ki v odboru mreže zastopa nacionalno klinično raziskovalno mrežo, kot določa člen 9(1) tega statuta.
In absence of the delegate, a proxy shall be designated.
V primeru odsotnosti pooblaščenca se imenuje namestnik.
Scientific Partners shall assign a coordinating centre (National Clinical Research Hub), which acts as the national contact point of ECRIN-ERIC.
Znanstveni partnerji določijo usklajevalni center (nacionalno klinično raziskovalno središče), ki deluje kot nacionalna kontaktna točka ECRIN-ERIC.