natgillin/translations-raw huggingface dataset:
The sponsor shall notify each Member State concerned of the end of a clinical trial in all Member States concerned and in all third countries in which the clinical trial has been conducted through the EU portal.
Kadar je bil namen kliničnega preskušanja pridobiti dovoljenje za promet za zdravilo v preskušanju, vlagatelj poleg povzetka rezultatov v podatkovno zbirko EU pošlje tudi poročilo o klinični študiji, in sicer 30 dni po dnevu, ko je bilo dovoljenje za promet odobreno, postopek odobritve dovoljenja za promet končan ali ko je vlagatelj umaknil vlogo za dovoljenje za promet.
That notification shall be made within 15 days from the end of the clinical trial in the last of the Member States concerned and third countries in which the clinical trial has been conducted.
Za primere, kadar se sponzor odloči, da bo prostovoljno delil neobdelane podatke, Komisija pripravi smernice za oblikovanje in izmenjavo teh podatkov.
The content of that summary is set out in Annex IV.
Obvestilo se pošlje v 15 dneh od začasne zaustavitve kliničnega preskušanja v vseh zadevnih državah članicah in vsebuje razloge za tako ukrepanje.
It shall be accompanied by a summary written in a manner that is understandable to laypersons.
Kadar se začasno ustavljeno klinično preskušanje iz odstavka 5 nadaljuje, sponzor prek portala EU o tem obvesti vsako zadevno državo članico.
The content of that summary is set out in Annex V.
Obvestilo se pošlje v 15 dneh po nadaljevanju začasno ustavljenega kliničnega preskušanja v vseh zadevnih državah članicah.
However, where, for scientific reasons detailed in the protocol, it is not possible to submit a summary of the results within one year, the summary of results shall be submitted as soon as it is available.
Če se začasno ustavljeno klinično preskušanje v dveh letih ne nadaljuje, se v tej uredbi za konec kliničnega preskušanja šteje datum, ko se izteče to dveletno obdobje, ali datum odločitve sponzorja o nenadaljevanju kliničnega preskušanja, kar je pozneje.
In this case, the protocol shall specify when the results are going to be submitted, together with a justification.
V primeru predčasne ustavitve kliničnega preskušanja se datum predčasne ustavitve šteje za datum konca kliničnega preskušanja.
In addition to the summary of the results, where the clinical trial was intended to be used for obtaining a marketing authorisation for the investigational medicinal product, the applicant for marketing authorisation shall submit to the EU database the clinical study report within 30 days after the day the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for marketing authorisation has withdrawn the application.
V primeru predčasne ustavitve kliničnega preskušanja iz razlogov, ki ne vplivajo na razmerje med koristmi in tveganji, sponzor prek portala EU obvesti vsako zadevno državo članico o razlogih za tako ukrepanje in po potrebi o nadaljnjih ukrepih za udeležence.
For cases where the sponsor decides to share raw data on a voluntary basis, the Commission shall produce guidelines for the formatting and sharing of those data.
Kadar je pred koncem kliničnega preskušanja v protokolu določen datum za vmesno analizo podatkov in so na voljo ustrezni rezultati kliničnega preskušanja, se brez poseganja v odstavek 4 povzetek navedenih rezultatov pošlje v podatkovno zbirko EU v enem letu od datuma vmesne analize podatkov.
The sponsor shall notify each Member State concerned of a temporary halt of a clinical trial in all Member States concerned for reasons not affecting the benefit-risk balance through the EU portal.
Člen 38
That notification shall be made within 15 days from the temporary halt of the clinical trial in all Member States concerned and shall include the reasons for such action.
Začasna ustavitev ali predčasna ustavitev preskušanja s strani sponzorja zaradi varnosti udeležencev
When a temporarily halted clinical trial referred to in paragraph 5 is resumed the sponsor shall notify each Member State concerned through the EU portal.
Za namene te uredbe se začasna ustavitev ali predčasna ustavitev kliničnega preskušanja zaradi spremembe razmerja med koristmi in tveganji prek portala EU sporoči zadevnim državam članicam.
That notification shall be made within 15 days from the restart of the temporarily halted clinical trial in all Member States concerned.
Obvestilo se pošlje brez odlašanja, vendar najpozneje v 15 dneh od dneva začasne ali predčasne ustavitve.
If a temporarily halted clinical trial is not resumed within two years, the expiry date of this period or the date of the decision of the sponsor not to resume the clinical trial, whichever is earlier, shall be deemed to be the date of the end of the clinical trial.
Vsebuje razloge za tako ukrepanje in opredeljene nadaljnje ukrepe.
In the case of early termination of the clinical trial, the date of the early termination shall be deemed to be the date of the end of the clinical trial.
Nadaljevanje kliničnega preskušanja po začasni ustavitvi iz odstavka 1 šteje za bistveno spremembo kliničnega preskušanja, zanjo pa se uporabljajo postopki odobritve iz poglavja III.
In the case of early termination of the clinical trial for reasons not affecting the benefit-risk balance, the sponsor shall notify each Member State concerned through the EU portal of the reasons for such action and, when appropriate, follow-up measures for the subjects.
Člen 39
Without prejudice to paragraph 4, where the clinical trial protocol provides for an intermediate data analysis date prior to the end of the clinical trial, and the respective results of the clinical trial are available, a summary of those results shall be submitted to the EU database within one year of the intermediate data analysis date.
Posodobljena vsebina povzetka rezultatov kliničnih preskušanj in povzetka za nestrokovnjake
Article 38
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 89 za spreminjanje prilog IV in V zaradi njune prilagoditve tehničnemu napredku ali zaradi upoštevanja sprememb v mednarodnem ureditvenem okviru, v katerem sodelujejo Unija ali države članice, na področju kliničnega preskušanja.
Temporary halt or early termination by the sponsor for reasons of subject safety
POGLAVJE VII
For the purposes of this Regulation, the temporary halt or early termination of a clinical trial for reasons of a change of the benefit-risk balance shall be notified to the Member States concerned through the EU portal.
VARNOSTNA POROČILA PRI KLINIČNEM PRESKUŠANJU
That notification shall be made without undue delay but not later than in 15 days of the date of the temporary halt or early termination.
Člen 40
It shall include the reasons for such action and specify follow-up measures.
Elektronska podatkovna zbirka za varnostna poročila
The restart of the clinical trial following a temporary halt as referred to in paragraph 1 shall be deemed to be a substantial modification subject to the authorisation procedure laid down in Chapter III.
1.
Article 39
Evropska agencija za zdravila, ustanovljena z Uredbo (ES) št. 726/2004 (v nadaljnjem besedilu: Agencija), vzpostavi in vzdržuje elektronsko podatkovno zbirko za poročila iz členov 42 in 43.
Update of the contents of the summary of results and summary for laypersons
Ta podatkovna zbirka je modul podatkovne zbirke iz člena 24 Uredbe (ES) št. 726/2004 (v nadaljnjem besedilu: podatkovna zbirka EudraVigilance).
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to amend Annexes IV and V, 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.
Agencija v sodelovanju z državami članicami razvije standardni spletni obrazec, s katerim bodo lahko sponzorji v zbirko podatkov iz odstavka 1sporočali sum na nepričakovane resne neželene učinke.
CHAPTER VII
Člen 41
SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL
Poročanje raziskovalca sponzorju o neželenih dogodkih in resnih neželenih učinkih
Article 40
Raziskovalec v skladu z zahtevami za poročanje in v rokih, določenih v protokolu, zabeleži in dokumentira ter sponzorju sporoči neželene dogodke ali laboratorijske anomalije, ki so v protokolu opredeljeni kot odločilni za oceno varnosti.
Electronic database for safety reporting
Raziskovalec zabeleži in dokumentira vse neželene dogodke, razen če je v protokolu določeno drugače.
The European Medicines Agency established by Regulation (EC) No 726/2004 (the ‘Agency’) shall set up and maintain an electronic database for the reporting provided for in Articles 42 and 43.
Raziskovalec sponzorju sporoči vse resne neželene dogodke, ki se pojavijo pri udeležencih v kliničnem preskušanju, razen če je v protokolu določeno drugače.
That database shall be a module of the database referred to in Article 24 of Regulation (EC) No 726/2004 (the ‘Eudravigilance database’).
Raziskovalec sponzorju poroča o resnih neželenih dogodkih brez odlašanja, vendar ne pozneje kot v 24 urah po tem, ko izve zanje, razen če je v protokolu določeno, da za nekatere neželene dogodke takojšnje poročanje ni potrebno.
The Agency shall, in collaboration with Member States, develop a standard web-based structured form for the reporting by sponsors to the database referred to in paragraph 1 of suspected unexpected serious adverse reactions.
Raziskovalec po potrebi sponzorju pošlje naknadno poročilo in mu tako omogoči oceno, ali bo resni neželeni učinek vplival na razmerje med koristmi in tveganji v kliničnem preskušanju.
Article 41
Sponzor vodi natančno evidenco vseh neželenih dogodkov, ki mu jih sporoči raziskovalec.
Reporting of adverse events and serious adverse events by the investigator to the sponsor
Če raziskovalec izve za resen neželen dogodek, pri katerem obstaja sum vzročne povezave z zdravilom v preskušanju in do katerega po koncu kliničnega preskušanja pride pri udeležencu, ki je bil s tem zdravilom zdravljen, raziskovalec to nemudoma sporoči sponzorju.
The investigator shall record and document adverse events or laboratory abnormalities identified in the protocol as critical to the safety evaluation and report them to the sponsor in accordance with the reporting requirements and within the periods specified in the protocol.
Člen 42
The investigator shall record and document all adverse events, unless the protocol provides differently.
Poročanje sponzorja Agenciji o sumih na nepričakovane resne neželene učinke
The investigator shall report to the sponsor all serious adverse events occurring to subjects treated by him or her in the clinical trial, unless the protocol provides differently.
Sponzor kliničnega preskušanja, ki se izvaja v vsaj eni državi članici, v elektronski obliki in brez odlašanja pošilja v podatkovno zbirko iz člena 40(1) vse ustrezne informacije o sumu na naslednje nepričakovane, resne neželene učinke:
The investigator shall report serious adverse events to the sponsor without undue delay but not later than within 24 hours of obtaining knowledge of the events, unless, for certain serious adverse events, the protocol provides that no immediate reporting is required.
vsi sumi na nepričakovane resne neželene učinke zdravila v preskušanju, ki se pojavljajo v tem kliničnem preskušanju, ne glede na to, ali do suma pride na kraju kliničnega preskušanja v Uniji ali v tretji državi;
Where relevant, the investigator shall send a follow-up report to the sponsor to allow the sponsor to assess whether the serious adverse event has an impact on the benefit-risk balance of the clinical trial.
vsi sumi na nepričakovane resne neželene učinke, povezanih z isto zdravilno učinkovino, ne glede na farmacevtsko obliko in odmerek ali indikacijo, ki se raziskujeta za zdravilo v preskušanju, ki se uporabi za to klinično preskušanje, do katerih pride v kliničnem preskušanju, izvedenem izključno v tretji državi, če to klinično preskušanje sponzorira:
The sponsor shall keep detailed records of all adverse events reported to it by the investigator.
isti sponzor ali
If the investigator becomes aware of a serious adverse event with a suspected causal relationship to the investigational medicinal product that occurs after the end of the clinical trial in a subject treated by him or her, the investigator shall, without undue delay, report the serious adverse event to the sponsor.
drug sponzor, ki je del iste matične družbe kot sponzor kliničnega preskušanja, ali ki skupaj s sponzorjem kliničnega preskušanja razvija zdravilo na podlagi formalnega sporazuma.
Article 42
Za ta namen zagotavljanje zdravila v preskušanju ali informacij o varnosti morebitnemu bodočemu imetniku dovoljenja za promet z zdravilom ne šteje za skupni razvoj, ter
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
vsi sumi na nepričakovane resne neželene učinke zdravila v preskušanju, ki se pojavijo pri katerem koli udeležencu kliničnega preskušanja, ki jih sponzor ugotovi ali opazi po koncu kliničnega preskušanja.
The sponsor of a clinical trial performed in at least one Member State shall report electronically and without delay to the database referred to in Article 40(1) all relevant information about the following suspected unexpected serious adverse reactions.:
Pri roku za sponzorjevo poročanje o nepričakovanih resnih neželenih učinkih Agenciji se upošteva resnost učinka, in sicer:
all suspected unexpected serious adverse reactions to investigational medicinal products occurring in that clinical trial, irrespective of whether the suspected unexpected serious adverse reaction has occurred at a clinical trial site in the Union or in a third country;
v primeru suma na nepričakovane resne neželene učinke, ki so smrtni ali življenjsko nevarni, čim prej in v vsakem primeru najpozneje sedem dni po tem, ko sponzor izve za učinek;
all suspected unexpected serious adverse reactions related to the same active substance, regardless of pharmaceutical form and strength or indication investigated, in investigational medicinal products used in the clinical trial, occurring in a clinical trial performed exclusively in a third country, if that clinical trial is sponsored:
v primeru suma na nepričakovane resne neželene učinke, ki niso smrtni ali življenjsko nevarni, najpozneje 15 dni po tem, ko sponzor izve za učinek;
by that sponsor, or
v primeru suma na nepričakovane resne neželene učinke, za katere se je sprva domnevalo, da niso smrtni ali življenjsko nevarni, pa se izkaže, da vendarle so, čim prej in v vsakem primeru najpozneje sedem dni po tem, ko sponzor izve, da je učinek smrten ali življenjsko nevaren.
by another sponsor who is either part of the same parent company as the sponsor of the clinical trial, or who develops a medicinal product jointly, on the basis of a formal agreement, with the sponsor of the clinical trial.
Po potrebi lahko sponzor v skladu z oddelkom 2.4 Priloge III zaradi zagotovitve pravočasnega poročanja najprej predloži začetno nepopolno poročilo, pozneje pa še popolno poročilo.
For this purpose, provision of the investigational medicinal product or information to a future potential marketing authorisation holder on safety matters shall not be considered a joint development; and
Kadar sponzor zaradi pomanjkanja virov ne more pošiljati poročil v podatkovno zbirko iz člena 40(1) in pridobi ustrezno soglasje zadevne države članice, lahko poroča državi članici, v kateri se je pojavil sum na nepričakovan resen neželen učinek.
all suspected unexpected serious adverse reactions to investigational medicinal products occurring in any of the subjects of the clinical trial, which are identified by or come to the attention of the sponsor after the end of the clinical trial.
Navedena država članica o sumu na nepričakovan resen neželen učinek poroča v skladu z odstavkom 1 tega člena.
The period for the reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency shall take account of the seriousness of the reaction and shall be as follows:
Člen 43
in the case of fatal or life-threatening suspected unexpected serious adverse reactions, as soon as possible and in any event not later than seven days after the sponsor became aware of the reaction;
Letna poročila sponzorja Agenciji
in the case of non-fatal or non-life-threatening suspected unexpected serious adverse reactions, not later than 15 days after the sponsor became aware of the reaction;
Za zdravila v preskušanju razen placeba sponzor vsako leto prek podatkovne zbirke iz člena 40(1) predloži Agenciji poročilo o varnosti vsakega posameznega zdravila v preskušanju, ki se uporablja pri kliničnem preskušanju, katerega sponzor je.
in the case of a suspected unexpected serious adverse reaction which was initially considered to be non-fatal or non-life threatening but which turns out to be fatal or life-threatening, as soon as possible and in any event not later than seven days after the sponsor became aware of the reaction being fatal or life-threatening.
V primeru kliničnega preskušanja, pri katerem se uporablja več zdravil v preskušanju, lahko sponzor,– če je tako predvideno v protokolu,– predloži eno varnostno poročilo za vsa zdravila v preskušanju, ki se pri tem kliničnem preskušanju uporabljajo.
Where necessary to ensure timely reporting, the sponsor may, in accordance with section 2.4 of Annex III, submit an initial incomplete report followed up by a complete report.
Letno poročilo iz odstavka 1 vsebuje le zbirne in anonimne podatke.
Where a sponsor, due to a lack of resources, does not have the possibility to report to the database referred to in Article 40(1) and the sponsor has the agreement of the Member State concerned, it may report to the Member State where the suspected unexpected serious adverse reaction occurred.
Obveznost iz odstavka 1 se začne s prvo odobritvijo kliničnega preskušanja v skladu s to uredbo.
That Member State shall report the suspected unexpected serious adverse reaction in accordance with paragraph 1 of this Article.
Konča se s koncem zadnjega kliničnega preskušanja, ki ga izvede sponzor z zdravilom v preskušanju.
Article 43
Člen 44
Annual reporting by the sponsor to the Agency
Ocena s strani držav članic
Regarding investigational medicinal products other than placebo, the sponsor shall submit annually through the database referred to in Article 40(1) to the Agency a report on the safety of each investigational medicinal product used in a clinical trial for which it is the sponsor.
Agencija v elektronski obliki posreduje zadevnim državam članicam informacije, o katerih je bila obveščena v skladu s členoma 42 in 43.
In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may, if provided for in the protocol, submit a single safety report on all investigational medicinal products used in that clinical trial.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 88(2).
The annual report referred to in paragraph 1 shall only contain aggregate and anonymised data.
Pri oceni informacij iz odstavkov 1 in 2 sodeluje pristojni odbor za etična vprašanja, če je tako določeno v pravu zadevne države članice.
The obligation referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation.
Člen 45
It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product.
Tehnični vidiki
Assessment by Member States
Kadar je potrebno zaradi večje zaščite udeležencev, se na Komisijo prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 89 za spremembo Priloge III iz katerega od naslednjih razlogov:
The Agency shall, by electronic means, forward to the Member States concerned the information reported in accordance with Article 42 and 43.
izboljšanja informacij o varnosti zdravil;
Member States shall cooperate in assessing the information reported in accordance with Articles 42and 43.
prilagajanja tehničnih zahtev tehničnemu napredku;
The Commission may, by means of implementing acts, set up and modify the rules on such cooperation.
upoštevanja sprememb v mednarodnem ureditvenem okviru na področju varnostnih zahtev v kliničnih preskušanjih, ki jih sprejmejo telesa, v katerih sodeluje Unija ali države članice.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(2).
Člen 46
The responsible ethics committee shall be involved in the assessment of the information referred to in paragraphs 1 and 2, if it has been provided for in the law of the Member State concerned.
Poročanje o pomožnih zdravilih
Article 45
Varnostna poročila o pomožnih zdravilih se pripravijo v skladu s poglavjem 3 naslova IX Direktive 2001/83/ES.
Technical aspects
Poglavje VIII
Technical aspects for safety reporting in accordance with Articles 41 to 44 are contained in Annex III.
IZVEDBA KLINIČNEGA PRESKUŠANJA, SPREMLJANJE S STRANI SPONZORJA, USPOSABLJANJE IN IZKUŠNJE, POMOžNA ZDRAVILA
Where necessary in order to improve the level of protection of subjects, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to amend Annex III for any of the following purposes:
Člen 47
improving the information on the safety of medicinal products;
Skladnost s protokolom in dobro klinično prakso
adapting technical requirements to technical progress;
Sponzor kliničnega preskušanja in raziskovalec zagotovita, da se klinično preskušanje izvede v skladu s protokolom in v skladu z načeli dobre klinične prakse.
taking account of international regulatory developments in the field of safety requirements in clinical trials, endorsed by bodies in which the Union or the Member States participate.
Sponzor in raziskovalec pri pripravi protokola ter pri uporabi te uredbe in protokola brez poseganja v druge določbe prava Unije ali v smernice Komisije ustrezno upoštevata tudi standarde kakovosti in smernice ICH o dobri klinični praksi.
Article 46
Komisija zagotovi, da so podrobne smernice ICH o dobri klinični praksi iz drugega odstavka javno dostopne.
Reporting with regard to auxiliary medicinal products
Člen 48
Safety reporting with regard to auxiliary medicinal products shall be made in accordance with Chapter 3 of Title IX of Directive 2001/83/EC.
Spremljanje
CHAPTER VIII
Da se zagotovi ustrezno varstvo pravic, varnosti in dobrobiti udeležencev, zanesljivost in ponovljivost podatkov in skladnost kliničnega preskušanja z zahtevami te uredbe, sponzor ustrezno spremlja izvajanje kliničnega preskušanja.
CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS
Sponzor določi obseg in vrsto spremljanja na podlagi ocene z upoštevanjem vseh značilnosti kliničnega preskušanja, vključno z naslednjimi:
Article 47
ali gre za klinično preskušanje z minimalno intervencijo;
Compliance with the protocol and good clinical practice
ciljev in metodologije kliničnega preskušanja ter
The sponsor of a clinical trial and the investigator shall ensure that the clinical trial is conducted in accordance with the protocol and with the principles of good clinical practice.
stopnje odstopanja intervencije od običajne klinične prakse.
Without prejudice to any other provision of Union law or Commission guidelines, the sponsor and the investigator, when drawing up the protocol and when applying this Regulation and the protocol, shall also take appropriate account of the quality standards and the ICH guidelines on good clinical practice.
Člen 49
The Commission shall make publicly available the detailed ICH guidelines on good clinical practice referred to in the second paragraph.
Primernost posameznikov, ki sodelujejo pri izvajanju kliničnega preskušanja
Article 48
Raziskovalec je zdravnik, kot je opredeljen v nacionalnem pravu, ali oseba, ki opravlja poklic, ki je v zadevni državi članici priznan kot primeren za raziskovalca zaradi potrebnega strokovnega znanja in izkušenj z obravnavo pacientov.
Monitoring
Drugi posamezniki, ki so vključeni v izvajanje kliničnega preskušanja, so po izobrazbi, usposobljenosti in izkušnjah ustrezno kvalificirani.