natgillin/translations-raw huggingface dataset:
The members of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have agreed on a detailed set of guidelines on good clinical practice which is an internationally accepted standard for designing, conducting, recording and reporting clinical trials, consistent with principles that have their origin in the World Medical Association's Declaration of Helsinki.
Člani Mednarodne konference o usklajevanju tehničnih zahtev za registracijo zdravil za uporabo v humani medicini (ICH) so se dogovorili o podrobnih smernicah za dobro klinično prakso, ki so zdaj mednarodno sprejeti standardi za načrtovanje, izvajanje, evidentiranje kliničnih preskušanj in poročanje o njih; te smernice so skladne z načeli iz Helsinške deklaracije Svetovne zdravniške organizacije.
When designing, conducting, recording and reporting clinical trials, detailed questions may arise as to the appropriate quality standard.
Pri načrtovanju, izvajanju in evidentiranju kliničnih preskušanj ter poročanju o njih se lahko pojavijo podrobna vprašanja glede ustreznega standarda kakovosti.
In such a case, the ICH guidelines on good clinical practice should be taken appropriately into account for the application of the rules set out in this Regulation, provided that there is no other specific guidance issued by the Commission and that those guidelines are compatible with this Regulation.
V takem primeru bi bilo treba smernice ICH o dobri klinični praksi ustrezno upoštevati pri uporabi pravil iz te uredbe, če ni drugih posebnih navodil Komisije in če so smernice skladne s to uredbo.
The conduct of a clinical trial should be adequately monitored by the sponsor in order to ensure the reliability and robustness of the results.
Sponzor bi moral ustrezno spremljati izvajanje kliničnega preskušanja, da se zagotovita zanesljivost in ponovljivost rezultatov.
Monitoring may also contribute to subject safety, taking into account the characteristics of the clinical trial and respect for fundamental rights of subjects.
Spremljanje lahko tudi prispeva k varnosti udeleženca, pri čemer se upoštevajo značilnosti kliničnega preskušanja in spoštujejo temeljne pravice udeležencev.
When establishing the extent of monitoring, the characteristics of the clinical trial should be taken into account.
Pri določitvi obsega spremljanja bi bilo treba upoštevati značilnosti kliničnega preskušanja.
The individuals involved in conducting a clinical trial, in particular investigators and other healthcare professionals, should be sufficiently qualified to perform their tasks, and the facilities where a clinical trial is to be conducted should be suitable for that clinical trial.
Posamezniki, ki so vključeni v izvajanje kliničnega preskušanja, zlasti raziskovalci in drugi zdravstveni delavci, bi morali biti ustrezno usposobljeni za izvajanje svojih nalog, prostori, v katerih se klinično preskušanje izvaja, pa bi morali biti primerni za klinično preskušanje.
In order to ensure subject safety and the reliability and robustness of data from clinical trials, it is appropriate to provide that there should be arrangements for traceability, storage, return and destruction of investigational medicinal products, depending on the nature of the clinical trial.
Da se zagotovijo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnih preskušanj, je primerno predvideti določbe glede sledljivosti, shranjevanja, vračanja in uničenja zdravil v preskušanju, odvisno, za kakšno klinično preskušanje gre.
For the same reasons, there should also be such arrangements for unauthorised auxiliary medicinal products.
Iz istih razlogov bi morali predvideti te določbe tudi za neodobrena pomožna zdravila.
During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of that clinical trial.
Sponzor lahko med kliničnim preskušanjem ugotovi hude kršitve pravil za izvajanje tega kliničnega preskušanja.
This should be reported to the Member States concerned in order for action to be taken by those Member States, where necessary.
O tem bi moral obvestiti zadevne države članice, da glede tega po potrebi ukrepajo.
Apart from the reporting of suspected unexpected serious adverse reactions, there may be other events which are relevant in terms of benefit-risk balance and which should be reported in a timely manner to the Member States concerned.
Sponzor bi moral zadevnim državam članicam poleg sumov na nepričakovane resne neželene učinke pravočasno sporočiti tudi druge pomembne dogodke glede razmerja med tveganji in koristmi.
It is important for subject safety that, in addition to serious adverse events and reactions, all unexpected events that might materially influence the benefit-risk assessment of the medicinal product or that would lead to changes in the administration of a medicinal product or in overall conduct of a clinical trial are notified to the Member States concerned.
Za varnost udeležencev je pomembno, da se zadevne države članice uradno obvesti ne le o resnih neželenih dogodkih in učinkih, temveč tudi o vseh nepričakovanih dogodkih, ki bi lahko bistveno vplivali na oceno tveganj in koristi zdravila ali povzročili spremembe pri dajanju zdravila ali v celotnem izvajanju kliničnega preskušanja.
Examples of such unexpected events include an increase in the rate of occurrence of expected serious adverse reactions which may be clinically important, a significant hazard to the patient population, such as lack of efficacy of a medicinal product, or a major safety finding from a newly completed animal study (such as carcinogenicity).
Primeri takih nepričakovanih dogodkov vključujejo povečanje pojavnosti pričakovanih resnih neželenih učinkov, ki so lahko klinično pomembni, veliko tveganje za skupino pacientov, na primer zaradi neučinkovitosti zdravila, ali pomembnejšo ugotovitev glede varnosti iz pravkar dokončane študije na živalih (npr. kancerogenost).
Where unexpected events require an urgent modification of a clinical trial, it should be possible for the sponsor and the investigator to take urgent safety measures without awaiting prior authorisation.
Kadar je zaradi nepričakovanih dogodkov potrebna nujna sprememba kliničnega preskušanja, bi bilo treba sponzorju in raziskovalcu omogočiti, da brez predhodne odobritve sprejmeta nujne varnostne ukrepe.
If such measures constitute a temporary halt of the clinical trial, the sponsor should apply for a substantial modification before restarting the clinical trial.
Če to pomeni začasno ustavitev kliničnega preskušanja, bi moral sponzor pred nadaljevanjem zaprositi za bistveno spremembo.
In order to ensure compliance of the conduct of a clinical trial with the protocol, and in order for investigators to be informed about the investigational medicinal products they administer, the sponsor should supply the investigators with an investigator's brochure.
Zaradi zagotavljanja skladnosti izvedbe kliničnega preskušanja s protokolom in zaradi obveščanja raziskovalcev o danih zdravilih v preskušanju bi moral sponzor raziskovalcem zagotoviti brošuro za raziskovalca.
The information generated in a clinical trial should be recorded, handled and stored adequately for the purpose of ensuring subject rights and safety, the robustness and reliability of the data generated in the clinical trial, accurate reporting and interpretation, effective monitoring by the sponsor and effective inspection by Member States.
Informacije iz kliničnega preskušanja bi bilo treba evidentirati, obdelati in ustrezno shraniti zaradi zagotavljanja pravic in varnosti udeležencev, zanesljivosti in ponovljivosti podatkov iz kliničnega preskušanja, natančnega poročanja in razlaganja, učinkovitega spremljanja s strani sponzorja ter učinkovitih kontrol s strani držav članic.
In order to be able to demonstrate compliance with the protocol and with this Regulation, a clinical trial master file, containing relevant documentation to allow effective supervision (monitoring by the sponsor and inspection by Member States), should be kept by the sponsor and by the investigator.
Zaradi dokazovanja skladnosti s protokolom in s to uredbo bi morala sponzor in raziskovalec shraniti glavno dokumentacijo kliničnega preskušanja zdravila z ustreznimi informacijami za učinkovito nadziranje (spremljanje s strani sponzorja ter kontrola s strani držav članic).
The clinical trial master file should be archived appropriately to allow for supervision after the clinical trial has ended.
Glavno dokumentacijo kliničnega preskušanja zdravila bi bilo treba ustrezno arhivirati, da se omogoči nadzor po koncu kliničnega preskušanja.
Where there are problems with respect to the availability of authorised auxiliary medicinal products, unauthorised auxiliary medicinal products may be used in a clinical trial in justified cases.
V primeru težav z dostopnostjo odobrenih pomožnih zdravil se v upravičenih primerih v kliničnih preskušanjih lahko uporabljajo neodobrena pomožna zdravila.
The price of the authorised auxiliary medicinal product should not be considered as having an effect on the availability of such medicinal products.
Cena odobrenega pomožnega zdravila se ne bi smela upoštevati, kot da vpliva na dostopnost teh zdravil.
Medicinal products intended for research and development trials fall outside the scope of Directive 2001/83/EC of the European Parliament and of the Council [5].
Zdravila za raziskave in razvojna preskušanja ne spadajo v področje uporabe Direktive 2001/83/ES Evropskega parlamenta in Sveta [5].
Such medicinal products include medicinal products used in the context of a clinical trial.
To so na primer zdravila, ki se uporabljajo pri kliničnem preskušanju.
They should be covered by specific rules taking account of their peculiarities.
Za ta zdravila bi morala veljati posebna pravila, ki bi upoštevala njihove posebnosti.
In establishing these rules, a distinction should be made between investigational medicinal products (the tested product and its reference products, including placebos) and auxiliary medicinal products (medicinal products used in the context of a clinical trial but not as investigational medicinal products), such as medicinal products used for background treatment, challenge agents, rescue medication, or used to assess end-points in a clinical trial.
Pri določanju teh pravil bi bilo treba razlikovati med zdravili v preskušanju (preskušana zdravila in primerjalna zdravila, vključno s placebom) in pomožnimi zdravili (zdravila, ki se uporabljajo pri kliničnih preskušanjih, vendar ne kot zdravila v preskušanju), kot so zdravila za osnovno zdravljenje, snovi, ki izzovejo določeno reakcijo, reševalna zdravila ali zdravila, ki se uporabljajo za oceno spremenljivk ob koncu kliničnega preskušanja.
Auxiliary medicinal products should not include concomitant medications, that is medications unrelated to the clinical trial and not relevant for the design of the clinical trial.
Pomožna zdravila ne bi smela vključevati zdravil za hkratno zdravljenje, to je zdravil, ki niso povezana s kliničnim preskušanjem in niso relevantna za načrtovanje kliničnega preskušanja.
In order to ensure subject safety and the reliability and robustness of data generated in a clinical trial, and in order to allow for the distribution of investigational and auxiliary medicinal products to clinical trial sites throughout the Union, rules on the manufacturing and import of both investigational and auxiliary medicinal products should be established.
Da se zagotovijo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja ter da bi se omogočila distribucija zdravil v preskušanju in pomožnih zdravil do mest po vsej Uniji, kjer potekajo klinična preskušanja, bi bilo treba določiti pravila za proizvodnjo in uvoz zdravil v preskušanju in pomožnih zdravil.
As is already the case for Directive 2001/20/EC, those rules should reflect the existing rules of good manufacturing practices for products covered by Directive 2001/83/EC.
Navedena pravila bi morala odražati obstoječa pravila o dobrih proizvodnih praksah za zdravila, ki jih zajema Direktiva 2001/83/ES, kar za Direktivo 2001/20/ES že velja.
In some specific cases, it should be possible to allow deviations from those rules in order to facilitate the conduct of a clinical trial.
V nekaterih posebnih primerih bi bilo treba dovoliti odstopanja od teh pravil, da bi se olajšalo izvajanje kliničnega preskušanja.
Therefore, the applicable rules should allow for some flexibility, provided that subject safety, as well as reliability and robustness of the data generated in the clinical trial are not compromised.
Zato bi morala veljavna pravila omogočiti nekaj prilagodljivosti, če pri tem varnost udeležencev ter zanesljivost in ponovljivost podatkov, pridobljenih pri kliničnem preskušanju, niso ogrožene.
The requirement to hold an authorisation for manufacture or import of investigational medicinal products should not apply to the preparation of investigational radiopharmaceuticals from radionuclide generators, kits or radionuclide precursors in accordance with the manufacturer's instructions for use in hospitals, health centres or clinics taking part in the same clinical trial in the same Member State.
Zahteva, da je treba za proizvodnjo ali uvoz zdravil v preskušanju imeti dovoljenje, ne bi smela veljati za izdelavo radiofarmakov v preskušanju iz radionuklidnih generatorjev, radionuklidnih kompletov in radionuklidnih predhodnikov v skladu z navodili proizvajalca za uporabo v bolnišnicah, zdravstvenih domovih ali klinikah, udeleženih pri istem kliničnem preskušanju v isti državi članici.
Investigational and auxiliary medicinal products should be appropriately labelled in order to ensure subject safety and the reliability and robustness of data generated in clinical trials, and in order to allow for the distribution of those products to clinical trial sites throughout the Union.
Zdravila v preskušanju in pomožna zdravila bi bilo treba ustrezno označiti, da se zagotovijo varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja ter da se omogoči distribucija teh zdravil do mest po vsej Uniji, kjer potekajo klinična preskušanja.
The rules for labelling should be adapted to the risks to subject safety and the reliability and robustness of data generated in clinical trials.
Pravila za označevanje bi bilo treba prilagoditi tveganjem za varnost udeležencev ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja.
Where the investigational or auxiliary medicinal product have already been placed on the market as an authorised medicinal product in accordance with Directive 2001/83/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council [6], as a general rule no additional labelling should be required for clinical trials that do not involve the blinding of the label.
Če so zdravila v preskušanju ali pomožna zdravila že bila dana na trg kot zdravila, ki so pridobila dovoljenje za promet v skladu z Direktivo 2001/83/ES in Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta [6], dodatno označevanje praviloma ne bi bilo potrebno za klinična preskušanja, ki ne vključujejo zakrivanja nalepke.
Moreover, there are specific products, such as radiopharmaceuticals used as diagnostic investigational medicinal product, where the general rules on labelling are inappropriate in view of the very controlled setting of the use of radiopharmaceuticals in clinical trials.
Pri nekaterih posebnih zdravilih, denimo pri radiofarmakih, ki se uporabljajo kot zdravila v preskušanju za diagnosticiranje, so splošna pravila o označevanju neustrezna glede na zelo nadzorovane pogoje uporabe radiofarmakov v kliničnih preskušanjih.
In order to ensure clear responsibilities, the concept of a ‘sponsor’ of a clinical trial, in line with international guidelines, was introduced by Directive 2001/20/EC.
Za določitev jasnih odgovornosti je bil z Direktivo 2001/20/ES v skladu z mednarodnimi smernicami vpeljan pojem sponzorja kliničnega preskušanja.
This concept should be upheld.
Ta pojem bi bilo treba ohraniti.
In practice, there may be loose, informal networks of researchers or research institutions which jointly conduct a clinical trial.
V praksi lahko klinično preskušanje skupaj izvajajo razmeroma nepovezane, neformalne skupine raziskovalcev ali raziskovalnih ustanov.
Those networks should be able to be co-sponsors of a clinical trial.
Tem skupinam bi bilo treba omogočiti sosponzorstvo kliničnega preskušanja.
In order not to weaken the concept of responsibility in a clinical trial, where a clinical trial has several sponsors, they should all be subject to the obligations of a sponsor under this Regulation.
Če ima klinično preskušanje več sponzorjev, bi morali vsi izpolnjevati obveznosti sponzorja iz te uredbe, da pomen odgovornosti v kliničnem preskušanju ne bi oslabel.
However, the co-sponsors should be able to split up the responsibilities of the sponsor by contractual agreement.
Vendar bi si morali sosponzorji s pogodbenim sporazumom med sabo razdeliti sponzorske odgovornosti.
In order to ensure that enforcement action may be taken by Member States and that legal proceedings may be brought in appropriate cases, it is appropriate to provide that sponsors that are not established in the Union should be represented by a legal representative in the Union.
Da bi državam članicam v ustreznih primerih zagotovili možnost izvajanja kazenskega pregona in sodnih postopkov, je ustrezno predpisati, da bi morali sponzorje, ki nimajo sedeža v Uniji, v Uniji zastopati zakoniti zastopniki.
However in view of the divergent approaches of the Member States as regards civil and criminal liability, it is appropriate to leave to each Member State concerned, as regards its territory, the choice as to whether or not to require such a legal representative, provided that at least a contact person is established in the Union.
Ker pa se pristopi držav članic glede civilne in kazenske odgovornosti razhajajo, je ustrezno prepustiti posamezni državi članici izbiro, ali bo na svojem ozemlju zahtevala takega zakonitega zastopnika, vendar pod pogojem, da ima vsaj ena sponzorjeva kontaktna oseba sedež v Uniji.
Where, in the course of a clinical trial, damage caused to the subject leads to the civil or criminal liability of the investigator or the sponsor, the conditions for liability in such cases, including issues of causality and the level of damages and sanctions, should remain governed by national law.
Kadar je zaradi škode, ki jo utrpi udeleženec med kliničnim preskušanjem, sponzor ali raziskovalec civilno ali kazensko odgovoren, bi moralo pogoje za odškodninsko odgovornost v takih primerih, vključno z vprašanji vzročne zveze in višino odškodnin ter stopnjo sankcij, še naprej urejati nacionalno pravo.
In clinical trials compensation should be ensured for damages successfully claimed in accordance with the applicable laws.
Pri kliničnih preskušanjih bi bilo treba zagotoviti nadomestilo za škodo, ki je bila dokazana v skladu z veljavno zakonodajo.
Therefore Member States should ensure that systems for compensation for damages suffered by a subject are in place which are appropriate to the nature and the extent of the risk.
Države članice bi morale zato zagotoviti, da sistemi, vzpostavljeni za povračilo škode, ki so jo utrpeli udeleženci, ustrezajo naravi in obsegu škode.
The Member State concerned should be given the power to revoke the authorisation of a clinical trial, suspend a clinical trial or require the sponsor to modify a clinical trial.
Zadevna država članica bi morala imeti možnost preklicati odobritev kliničnega preskušanja, odložiti klinično preskušanje ali od sponzorja zahtevati spremembo kliničnega preskušanja.
In order to ensure compliance with this Regulation, Member States should be able to conduct inspections and should have adequate inspection capacities.
Za zagotovitev skladnosti s to uredbo bi morale države članice imeti možnost izvajati kontrole in bi morale imeti za to ustrezne vire.
The Commission should be able to control whether Member States correctly supervise compliance with this Regulation.
Komisiji bi moral biti omogočen nadzor nad tem, ali države članice pravilno nadzirajo skladnost s to uredbo.
Moreover, the Commission should be able to control whether regulatory systems of third countries ensure compliance with the specific provisions of this Regulation and Directive 2001/83/EC concerning clinical trials conducted in third countries.
Poleg tega bi morala imeti Komisija možnost nadzora nad tem, ali regulativni sistemi v tretjih državah zagotavljajo skladnost s posebnimi določbami te uredbe in Direktive 2001/83/ES glede kliničnih preskušanj, ki se izvajajo v tretjih državah.
In order to streamline and facilitate the flow of information between sponsors and Member States as well as between Member States, the Agency should, in collaboration with Member States and the Commission, set up and maintain an EU database, accessed through an EU portal.
Zaradi poenostavitve in lažjega pretoka informacij med sponzorji in državami članicami ter med samimi državami članicami bi morala Agencija v sodelovanju z državami članicami in Komisijo vzpostaviti in vzdrževati podatkovno zbirko EU, dostopno prek portala EU.
In order to ensure a sufficient level of transparency in the clinical trials, the EU database should contain all relevant information as regards the clinical trial submitted through the EU portal.
Da se v kliničnem preskušanju zagotovi zadostna stopnja preglednosti, bi morala podatkovna zbirka EU vsebovati vse relevantne informacije v zvezi s kliničnim preskušanjem, ki so bile posredovane prek portala EU.
The EU database should be publicly accessible and data should be presented in an easily searchable format, with related data and documents linked together by the EU trial number and with hyperlinks, for example linking together the summary, the layperson's summary, the protocol and the clinical study report of one clinical trial, as well as linking to data from other clinical trials which used the same investigational medicinal product.
Podatkovna zbirka EU bi morala biti javno dostopna, podatki pa predstavljeni v obliki, ki omogoča enostavno iskanje, vsebovati bi morala sorodne podatke in dokumente, ki bi bili medsebojno povezani s številko EU preskušanja in hiperpovezavami; tako bi morali biti na primer povzetek, povzetek za nestrokovnjake, protokol in poročilo o kliničnih študijah enega kliničnega preskušanja povezani s podatki iz drugih kliničnih preskušanj, pri katerih je bilo uporabljeno isto zdravilo v preskušanju.
All clinical trials should be registered in the EU database prior to being started.
Vsa klinična preskušanja bi bilo treba pred začetkom zabeležiti v podatkovno zbirko EU.
As a rule, the start and end dates of the recruitment of subjects should also be published in the EU database.
V podatkovni zbirki EU bi morala biti zabeležena tudi datuma začetka in konca pridobivanja udeležencev.
No personal data of data subjects participating in a clinical trial should be recorded in the EU database.
V podatkovni zbirki EU se ne bi smeli hraniti osebni podatki udeležencev v kliničnem preskušanju.
The information in the EU database should be public, unless specific reasons require that a piece of information should not be published, in order to protect the right of the individual to private life and the right to the protection of personal data, recognised by Articles 7 and 8 of the Charter.
Informacije v podatkovni zbirki EU bi morale biti javne, razen če ni iz posebnih razlogov potrebno, da se določene informacije ne objavijo zaradi zaščite pravice posameznika do zasebnega življenja in pravice do varstva osebnih podatkov, ki sta zagotovljeni v členih 7 in 8 Listine.
Publicly available information contained in the EU database should contribute to protecting public health and fostering the innovation capacity of European medical research, while recognising the legitimate economic interests of sponsors.
Javno dostopne informacije v podatkovni zbirki EU bi morale prispevati k varovanju javnega zdravja in spodbujanju zmogljivosti evropskih medicinskih raziskav za inovacije, obenem pa priznavati legitimne ekonomske interese sponzorjev.