natgillin/translations-raw huggingface dataset:
Persons assessing the application for a substantial modification
V dosjeju vloge za odobritev kliničnega preskušanja so vsi zahtevani dokumenti in informacije, ki so potrebni za potrditev in oceno iz poglavja II ter se nanašajo na:
Article 9 applies to assessments made under this Chapter.
izvajanje kliničnega preskušanja, vključno z znanstvenim ozadjem in sprejetimi ukrepi;
CHAPTER IV
sponzorja, raziskovalce, morebitne udeležence, udeležence in mesta kliničnega preskušanja;
APPLICATION DOSSIER
zdravila v preskušanju in po potrebi pomožna zdravila, zlasti na njihove lastnosti, označevanje, proizvodnjo in nadzor;
Article 25
ukrepe za zaščito udeležencev;
Data submitted in the application dossier
utemeljitev, zakaj gre za klinično preskušanje z minimalno intervencijo, v primerih, kadar tako zahteva sponzor.
The application dossier for the authorisation of a clinical trial shall contain all required documentation and information necessary for the validation and assessment referred to in Chapter II and relating to:
Seznam zahtevane dokumentacije in informacij je določen v Prilogi I.
the conduct of the clinical trial, including the scientific context and arrangements taken,
V dosjeju vloge za odobritev bistvene spremembe je vsa zahtevana dokumentacija in informacije, ki so potrebne za potrditev in oceno iz poglavja III:
the sponsor, investigators, potential subjects, subjects, and clinical trial sites;
sklicevanje na klinično preskušanje ali klinična preskušanja, ki so bistveno spremenjena, s številko EU preskušanja iz tretjega pododstavka člena 81(1) (v nadaljnjem besedilu: številka EU preskušanja);
the investigational medicinal products and, where necessary, the auxiliary medicinal products, in particular their properties, labelling, manufacturing and control;
jasen opis bistvene spremembe, predvsem njene narave, in razlogi za bistveno spremembo;
measures to protect subjects;
po potrebi predstavitev podatkov in dodatnih informacij v podporo bistveni spremembi;
justification as to why the clinical trial is a low-intervention clinical trial, in cases where this is claimed by the sponsor.
jasen opis posledic bistvene spremembe za pravice in varnost udeleženca ter zanesljivost in ponovljivost podatkov iz kliničnega preskušanja.
The list of required documentation and information is set out in Annex I.
Seznam zahtevane dokumentacije in informacij je določen v Prilogi II.
The application dossier for the authorisation of a substantial modification shall contain all required documentation and information necessary for the validation and assessment referred to in Chapter III:
Predložene neklinične informacije v dosjeju vloge temeljijo na podatkih, ki so pridobljeni v študijah, skladnih s pravom Unije o načelih dobre laboratorijske prakse, veljavnimi v času izvajanja teh študij.
a reference to the clinical trial or clinical trials which are substantially modified using the EU trial number referred to in the third subparagraph of Article 81(1) (the ‘EU trial number’);
Podatki, na katere se sklicuje v dosjeju vloge, izvirajo iz kliničnih preskušanj, izvedenih v skladu s to uredbo, ali, če so bila izvedena pred datumom iz drugega odstavka člena 99, v skladu z Direktivo 2001/20/ES.
a clear description of the substantial modification, in particular, the nature of and the reasons for substantial modification;
Kadar je bilo klinično preskušanje iz odstavka 4 izvedeno zunaj Unije, je moralo biti izvedeno v skladu z načeli, ki so glede pravic in varnosti udeležencev ter zanesljivosti in ponovljivosti podatkov iz kliničnega preskušanja enakovredna načelom iz te uredbe.
a presentation of data and additional information in support of the substantial modification, where necessary;
Podatki o kliničnem preskušanju, ki se je začelo po datumu iz drugega odstavka člena 99, se predložijo v dosjeju vloge le, če je bilo to klinično preskušanje evidentirano v javnem registru pred njegovim začetkom, ki predstavlja primarno evidenco ali sorodno evidenco, ali zagotavlja podatke za WHO ICTRP.
a clear description of the consequences of the substantial modification as regards the rights and safety of the subject and the reliability and robustness of the data generated in the clinical trial.
Podatki o kliničnem preskušanju, ki se je začelo pred datumom iz drugega odstavka člen 99 se predložijo v dosjeju vloge le, če je to klinično preskušanje evidentirano v javnem registru, ki predstavlja primarno evidenco ali sorodno evidenco, ali zagotavlja podatke za WHO ICTRP ali pa so bili njegovi rezultati objavljeni v neodvisni strokovno pregledani publikaciji.
The list of required documentation and information is set out in Annex II.
Podatki v dosjeju vloge, ki niso skladni z odstavki 3 do 6, se ne upoštevajo pri oceni vloge za odobritev kliničnega preskušanja ali bistvene spremembe.
Non-clinical information submitted in an application dossier shall be based on data derived from studies complying with Union law on the principles of good laboratory practice, as applicable at the time of performance of those studies.
Člen 26
Where reference is made in the application dossier to data generated in a clinical trial, that clinical trial shall have been conducted in accordance with this Regulation or, if conducted prior to the date referred to in the second paragraph of Article 99, in accordance with Directive 2001/20/EC.
Jezikovne zahteve
Where the clinical trial referred to in paragraph 4 has been conducted outside the Union, it shall have been conducted in accordance with principles equivalent to those of this Regulation as regards the rights and safety of the subject and the reliability and robustness of the data generated in the clinical trial.
Jezik dosjeja vloge ali njegovih delov določi zadevna država članica.
Data from a clinical trial started as from the date referred to in the second paragraph of Article 99 shall only be submitted in an application dossier if that clinical trial has been registered prior to its start in a public register which is a primary or partner registry of, or a data provider to, the WHO ICTRP.
Države članice pri uporabi prvega odstavka pretehtajo možnost dopustitve splošno razumljivega jezika na zdravstvenem področju za dokumentacijo, ki ni namenjena udeležencu.
Data from a clinical trial started before the date referred to in the second paragraph of Article 99 shall only be submitted in an application dossier if that clinical trial is registered in a public register which is a primary or partner registry of, or a data provider to, the WHO ICTRP or if the results of that clinical trial have been published in an independent peer-reviewed scientific publication.
Člen 27
Data submitted in an application dossier which do not comply with paragraphs 3 to 6 shall not be considered in the assessment of an application for authorisation of a clinical trial or of a substantial modification.
Posodobitev z delegiranimi akti
Article 26
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 85 v zvezi s spreminjanjem prilog I in II zaradi njune prilagoditve tehničnemu napredku ali zaradi upoštevanja sprememb v mednarodnem ureditvenem okviru, v katerem sodelujeta Unija ali države članice, na področju kliničnega preskušanja.
Language requirements
POGLAVJE V
The language of the application dossier, or parts thereof, shall be determined by the Member State concerned.
ZAŠČITA UDELEžENCEV IN PROSTOVOLJNA PRIVOLITEV PO POUČITVI
Member States, in applying the first paragraph, shall consider accepting, for the documentation not addressed to the subject, a commonly understood language in the medical field.
Člen 28
Article 27
A.1 Splošna pravila
Update by way of delegated acts
Klinično preskušanje se lahko izvede le v primeru, kadar so izpolnjeni vsi naslednji pogoji:
The Commission shall be empowered to adopt delegated acts in accordance with Article 85 in respect of amending Annexes I and II in order to adapt them to technical progress or to take account of international regulatory developments in which the Union or the Member States are involved, in the field of clinical trials.
pričakovane koristi pri zdravljenju za udeleženca ali za javno zdravje upravičujejo predvidena tveganja in neprijetnosti, upoštevanje tega pogoja pa se stalno spremlja;
CHAPTER V
udeleženci ali njihovi zakonito imenovani zastopniki, kadar udeleženci niso sposobni dati prostovoljne privolitve po poučitvi, so bili obveščeni v skladu s členom 29(2) do (6);
PROTECTION OF SUBJECTS AND INFORMED CONSENT
udeleženci ali njihovi zakonito imenovani zastopniki, kadar udeleženci niso sposobni dati prostovoljne privolitve po poučitvi, so dali prostovoljno privolitev po poučitvi v skladu s členom 29(1), (7) in (8);
Article 28
so pravice udeležencev do telesne in duševne celovitosti, zasebnosti in varstva njihovih osebnih podatkov v skladu z Direktivo 95/46/ES zaščitene.
General rules
klinično preskušanje je zasnovano tako, da povzroča čim manj bolečine, nelagodja, strahu in drugih predvidljivih tveganj za udeleženca in sta tako prag tveganja kot stopnja nelagodja natančno opredeljena v protokolu in pod stalnim nadzorom;
A clinical trial may be conducted only where all of the following conditions are met:
za zdravstveno oskrbo udeležencev je odgovoren ustrezno kvalificiran zdravnik ali po potrebi kvalificiran zobozdravnik;
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
udeležencu ali njegovemu zakonito imenovanemu zastopniku, če udeleženec ni sposoben dati prostovoljne privolitve po poučitvi, se zagotovijo kontaktni podatki ustanove, kjer je po potrebi mogoče dobiti dodatne informacije;
the subjects, or where a subject is not able to give informed consent, his or her legally designated representative, have been informed in accordance with Article 29(2) to (6);
udeležencev se ni neustrezno napeljevalo k sodelovanju v kliničnem preskušanju, niti v finančnem smislu.
the subjects, or where a subject is not able to give informed consent, his or her legally designated representative, have given informed consent in accordance with Article 29(1), (7) and (8);
Brez poseganja v Direktivo 95/46/ES lahko sponzor udeleženca ali njegovega zakonito imenovanega zastopnika, kadar udeleženec ni sposoben dati prostovoljne privolitve po poučitvi, ko udeleženec ali njegov zakonito imenovani zastopnik poda prostovoljno privolitev po poučitvi za sodelovanje v kliničnem preskušanju, prosi za privolitev za uporabo svojih podatkov zunaj protokola kliničnega preskušanja izključno za znanstvene namene.
the rights of the subjects to physical and mental integrity, to privacy and to the protection of the data concerning them in accordance with Directive 95/46/EC are safeguarded;
To privolitev lahko udeleženec ali njegov zakonito imenovani zastopnik kadar koli prekliče.
the clinical trial has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects and both the risk threshold and the degree of distress are specifically defined in the protocol and constantly monitored;
Znanstvene raziskave z uporabo podatkov izven protokola kliničnega preskušanja se izvajajo v skladu z veljavnim pravom o varstvu podatkov.
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner;
Vsak udeleženec ali njegov zakonito imenovani zastopnik, kadar udeleženec ni sposoben dati prostovoljne privolitve po poučitvi, se lahko brez kakršne koli škode kadar koli in brez obrazložitve umakne iz kliničnega preskušanja, tako da prekliče svojo prostovoljno privolitev po poučitvi.
the subject or, where the subject is not able to give informed consent, his or her legally designated representative has been provided with the contact details of an entity where further information can be received in case of need;
Brez poseganja v Direktivo 95/46/ES preklic prostovoljne privolitve po poučitvi ne vpliva na dejavnosti, ki so bile že izvedene in na uporabo podatkov, ki so bili že pridobljeni na podlagi prostovoljne privolitve po poučitvi pred njenim preklicem.
no undue influence, including that of a financial nature, is exerted on subjects to participate in the clinical trial.
Člen 29
Without prejudice to Directive 95/46/EC, the sponsor may ask the subject or, where the subject is not able to give informed consent, his or her legally designated representative at the time when the subject or the legally designated representative gives his or her informed consent to participate in the clinical trial to consent to the use of his or her data outside the protocol of the clinical trial exclusively for scientific purposes.
Prostovoljna privolitev po poučitvi
That consent may be withdrawn at any time by the subject or his or her legally designated representative.
Prostovoljno privolitev po poučitvi napiše, datira in podpiše oseba, ki je opravila predhodni razgovor iz točke (c) odstavka 2, in udeleženec ali njegov zakonito imenovani zastopnik, kadar udeleženec ne more podati prostovoljne privolitve po poučitvi, potem ko je bil ustrezno obveščen v skladu z odstavkom 2.
The scientific research making use of the data outside the protocol of the clinical trial shall be conducted in accordance with the applicable law on data protection.
Kadar udeleženec ne more pisati, se lahko privolitev poda na drugačen način v prisotnosti vsaj ene nepristranske priče, kar se dokumentira.
Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the clinical trial at any time by revoking his or her informed consent.
V tem primeru prostovoljno privolitev po poučitvi podpiše in datira priča.
Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.
Udeleženec ali njegov zakonito imenovani zastopnik, kadar udeleženec ne more podati prostovoljne privolitve po poučitvi, prejme izvod izjave (ali drugačen zapis) o prostovoljni privolitvi po poučitvi.
Article 29
Prostovoljna privolitev po poučitvi se dokumentira.
Informed consent
Udeležencu ali njegovem zakonito imenovanem zastopniku se zagotovi dovolj časa, da lahko razmisli o svoji odločitvi, da bo sodeloval v kliničnem preskušanju.
Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2.
Informacije, ki se dajo udeležencu ali njegovemu zakonito imenovanemu zastopniku, kadar udeleženec ne more podati prostovoljne privolitve po poučitvi, z namenom pridobitve prostovoljne privolitve po poučitvi:
Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness.
udeležencu ali njegovemu zakonito imenovanemu zastopniku omogočijo, da razume:
In that case, the witness shall sign and date the informed consent document.
naravo, cilje, koristi, posledice, tveganja in neprijetnosti kliničnega preskušanja;
The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document (or the record) by which informed consent has been given.
udeleženčeve pravice in zagotovila za njegovo zaščito, zlasti pa njegovo pravico, da zavrne sodelovanje in da se kadar koli in brez obrazložitve ter brez kakršne koli škode zanj umakne iz kliničnega preskušanja;
The informed consent shall be documented.
pogoje, pod katerimi se klinično preskušanje izvaja, vključno s predvidenim trajanjem udeleženčevega sodelovanja v kliničnem preskušanju, in
Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the clinical trial.
morebitna alternativna zdravljenja, vključno z ukrepi za nadaljnje spremljanje, če udeleženec ne sodeluje več v preskušanju;
Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
so izčrpne, kratke, jasne, ustrezne in razumljive nestrokovnjakom;
enable the subject or his or her legally designated representative to understand:
se zagotovijo v predhodnem razgovoru s članom raziskovalne skupine, ki je ustrezno usposobljen v skladu s pravom zadevne države članice;
the nature, objectives, benefits, implications, risks and inconveniences of the clinical trial;
zajemajo informacije o veljavnem odškodninskem sistemu iz člena 76(1) ter
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate and the right to withdraw from the clinical trial at any time without any resulting detriment and without having to provide any justification;
vključujejo številko EU preskušanja in informacije o razpoložljivosti rezultatov kliničnega preskušanja v skladu z odstavkom 6.
the conditions under which the clinical trial is to be conducted, including the expected duration of the subject's participation in the clinical trial; and
Informacije iz odstavka 2 se pripravijo v pisni obliki in so na voljo udeležencu ali njegovemu zakonito imenovanemu zastopniku, kadar udeleženec ne more podati prostovoljne privolitve po poučitvi.
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical trial is discontinued;
V predhodnem razgovoru iz točke (c) odstavka 2 se posebna pozornost nameni potrebam posebnih skupin pacientov in posameznih udeležencev po informacijah, kot tudi metodam za podajanje informacij.
be kept comprehensive, concise, clear, relevant, and understandable to a layperson;
V razgovoru iz točke (c) odstavka 2 se preveri, ali je udeleženec informacije razumel.
be provided in a prior interview with a member of the investigating team who is appropriately qualified according to the law of the Member State concerned;
Udeleženca se obvesti, da bo povzetek rezultatov kliničnega preskušanja in povzetek, pripravljen na način, ki je razumljiv nestrokovnjakom, v skladu s členom 37(4) na voljo v podatkovni zbirki EU iz člena 81 (v nadaljnjem besedilu: podatkovna zbirka EU) ne glede na izid kliničnega preskušanja in takoj, kolikor je mogoče, ko so povzetki na voljo.
include information about the applicable damage compensation system referred to in Article 76(1); and
Ta uredba ne posega v nacionalno pravo, ki zahteva, da se lahko na obrazcu o prostovoljni privolitvi po poučitvi zahteva tako podpis nezmožne osebe kot njenega zakonito imenovanega zastopnika.
include the EU trial number and information about the availability of the clinical trial results in accordance with paragraph 6.
Ta uredba ne posega v nacionalno pravo, ki zahteva, da mladoletnik, ki si je sposoben oblikovati mnenje in oceniti prejeto informacijo, poleg privolitve po poučitvi, ki jo predloži njegov zakonito imenovani zastopnik, še sam pristane, da se bo udeležil kliničnega preskušanja.
The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
Člen 30
In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
Prostovoljna privolitev po poučitvi pri preskušanjih, izvedenih v skupinah
In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
Kadar naj bi se klinično preskušanje izvajalo izključno v eni državi članici, lahko ta država članica brez poseganja v člen 35 in z odstopanjem od točk (b), (c), in (g) člena 28(1), člena 29(1), točke (c) člena 29(2), člena 29(3), (4) in (5), točk (a), (b) in (c) člena 31(1) ter točk (a), (b) in (c) člena 32(1) dovoli raziskovalcu, da pridobi prostovoljno privolitev po poučitvi po poenostavljenem postopku iz odstavka 2 tega člena, pod pogojem, da so izpolnjeni pogoji iz odstavka 3 tega člena.
The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperson will be made available in the EU database, referred to in Article 81 (the ‘EU database’), pursuant to Article 37(4), irrespective of the outcome of the clinical trial, and, to the extent possible, when the summaries become available.
Pri kliničnih preskušanjih, ki izpolnjujejo pogoje iz odstavka 3, se šteje, da je prostovoljna privolitev po poučitvi pridobljena, če:
This Regulation is without prejudice to national law requiring that both the signature of the incapacitated person and the signature of his or her legally designated representative may be required on the informed consent form.
se informacije, ki se zahtevajo v skladu s točkami (a), (b), (d) in (e) člena 29(2), podajo v skladu s tem, kar je določeno v protokolu pred vključitvijo udeleženca v klinično preskušanje, in je jasno navedeno predvsem to, da lahko udeleženec zavrne sodelovanje ali se kadar koli in brez kakršne koli škode umakne iz kliničnega preskušanja, ter
This Regulation is without prejudice to national law requiring that, in addition to the informed consent given by the legally designated representative, a minor who is capable of forming an opinion and assessing the information given to him or her, shall also assent in order to participate in a clinical trial.
po tem, ko je bil obveščen, morebitni udeleženec ne nasprotuje sodelovanju v kliničnem preskušanju.
Article 30
Prostovoljna privolitev po poučitvi se lahko pridobi po poenostavljenem postopku, kakor je določeno v odstavku 2, če so izpolnjeni naslednji pogoji:
Informed consent in cluster trials
poenostavljeni postopek za pridobitev prostovoljne privolitve po poučitvi ni v nasprotju z nacionalnim pravom zadevne države članice;
Where a clinical trial is to be conducted exclusively in one Member State, that Member State may, without prejudice to Article 35, and by way of derogation from points (b), (c), and (g) of Article 28(1), Article 29(1), point (c) of Article 29(2), Article 29(3), (4) and (5), points (a), (b) and (c) of Article 31(1) and points (a), (b) and (c) of Article 32(1), allow the investigator to obtain informed consent by the simplified means set out in paragraph 2 of this Article, provided that all of the conditions set out in paragraph 3 of this Article are fulfilled.
metodologija kliničnega preskušanja zahteva, da se za prejemanje različnih zdravil v preskušanju namesto posameznih udeležencev uporabijo skupine udeležencev;
For clinical trials that fulfil the conditions set out in paragraph 3, informed consent shall be deemed to have been obtained if:
gre za klinično preskušanje z minimalno intervencijo in se zdravila v preskušanju uporabljajo v skladu s pogoji dovoljenja za promet z zdravilom;
the information required under points (a), (b), (d) and (e) of Article 29(2) is given, in accordance with what is laid down in the protocol, prior to the inclusion of the subject in the clinical trial, and this information makes clear, in particular, that the subject can refuse to participate in, or withdraw at any time from, the clinical trial without any resulting detriment; and
razen običajnega zdravljenja udeležencev ni drugih intervencij;
the potential subject, after being informed, does not object to participating in the clinical trial.
v protokolu so utemeljeni razlogi, zakaj je bila prostovoljna privolitev po poučitvi pridobljena po poenostavljenem postopku, in je v njem opisan obseg informacij za udeležence ter način njihovega podajanja.