#641731
Is é an t-urraitheoir, nó ionadaí de chuid an urraitheora, a shíneoidh an t-iarratas.
The application shall be signed by the sponsor or a representative of the sponsor.
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#1890920
ciallaíonn “urratheoir” urraitheoir mar a shainmhínítear é i bpointe (e) d’Airteagal 2 de Threoir 2001/20/CE;
‘sponsor’ means sponsor as defined in point (e) of Article 2 of Directive 2001/20/EC;
#352622
urraitheoir (óstach, cuideachta, eagraíocht), sonraigh le do thoil
by a sponsor (host, company, organisation), please specify
#583177
Chuige sin, ba cheart don tionscnóir nó don urraitheoir leas suntasach a choinneáil sna sócmhainní foluiteacha.
To achieve this, the originator or sponsor should retain a significant interest in the underlying assets.
#586989
Institiúidí tionscnóra agus institiúidí is urraitheoirí
Originator and sponsor institutions
#589172
CEANGLAIS LE HAGHAIDH INSTITIÚIDÍ IS URRAITHEOIRÍ AGUS INSTITIÚIDÍ TIONSCNÓRA
REQUIREMENTS FOR SPONSOR AND ORIGINATOR INSTITUTIONS
#589189
na ceanglais in Airteagal 408- agus in Airteagal 409 a bhfuil feidhm acu maidir le hinstitiúidí is urraitheoirí agus institiúidí tionscóra.
the requirements in Articles 408 and 409 applying to sponsor and originator institutions.
#640619
Ba cheart go mbeadh deis ag an urraitheoir an t-iarratas ar údarú do thriail chliniciúil a tharraingt siar.
The sponsor should be allowed to withdraw the application for authorisation of a clinical trial.
#640854
Molfaidh an t-urraitheoir ceann de na Ballstáit lena mbaineann mar Bhallstát tuairiscithe.
The sponsor shall propose one of the Member States concerned as reporting Member State.
#640875
Cibé an triail chliniciúil idirghabhála ísle í an triail chliniciúil, i gcás ina maíonn an t-urraitheoir amhlaidh.
Whether the clinical trial is a low-intervention clinical trial, where claimed by the sponsor;
#640975
Féadfaidh an t-urraitheoir an t-iarratas a tharraingt siar tráth ar bith go dtí an dáta tuairiscithe.
The sponsor may withdraw the application at any time until the reporting date.
#641114
urraitheoir, imscrúdaitheoirí, daoine is ábhar ionchasacha, daoine is ábhar, agus suíomhanna um thrialacha cliniciúla;
the sponsor, investigators, potential subjects, subjects, and clinical trial sites;
#641282
Stopadh sealadach nó foirceannadh luath arna ndéanamh ag an urraitheoir ar mhaithe le sábháilteacht na ndaoine is ábhar
Temporary halt or early termination by the sponsor for reasons of subject safety
#641298
Tuairisciú ón imscrúdaitheoir chuig an urraitheoir maidir le teagmhais dhíobhálacha agus teagmhais dhíobhálacha thromchúiseacha
Reporting of adverse events and serious adverse events by the investigator to the sponsor
#641304
Coinneoidh an t-urraitheoir taifid mhionsonraithe de gach teagmhas díobhálach a thuairisceoidh an t-imscrúdaitheoir dó.
The sponsor shall keep detailed records of all adverse events reported to it by the investigator.
#641307
Tuairisciú maidir le frithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta ón urraitheoir chuig an nGníomhaireacht
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
#641311
an t-urraitheoir sin; nó
by that sponsor, or
#641312
ag urraitheoir eile ar cuid de mháthairchuideachta chéanna urraitheoir na trialach cliniciúla nó, más urraitheoir é a fhorbraíonn táirge íocshláinte, ar bhonn comhaontaithe fhoirmiúil, i gcomhar le hurraitheoir na trialach cliniciúla.
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.
#641323
Tuairisciú bliantúil ón urraitheoir chuig an nGníomhaireacht
Annual reporting by the sponsor to the Agency
#641347
STIÚRADH TRIALACH CLINICIÚLA, AN MHAOIRSEACHT A DHÉANFAIDH AN T-URRAITHEOIR, OILIÚINT AGUS TAITHÍ, TÁIRGÍ ÍOCSHLÁINTE CÚNTA
CONDUCT OF A CLINICAL TRIAL, SUPERVISION BY THE SPONSOR, TRAINING AND EXPERIENCE, AUXILIARY MEDICINAL PRODUCTS
#641391
Soláthróidh an t-urraitheoir bróisiúr an imscrúdaitheora don imscrúdaitheoir.
The sponsor shall provide the investigator with the investigator's brochure.
#641399
Coinneoidh an t-urraitheoir agus an t-imscrúdaitheoir máistirchomhad trialach cliniciúla.
The sponsor and the investigator shall keep a clinical trial master file.
#641410
Ceapfaidh an t-urraitheoir daoine aonair laistigh dá eagraíocht féin le bheith freagrach as na cartlanna.
The sponsor shall appoint individuals within its organisation to be responsible for archives.
#641488
URRAITHEOIR AGUS IMSCRÚDAITHEOIR
SPONSOR AND INVESTIGATOR
#641490
Urraitheoir
Sponsor
#641494
Féadfaidh an duine céanna a bheith ina imscrúdaitheoir agus ina urraitheoir.
The investigator and the sponsor may be the same person.
#641500
urraitheoir atá freagrach as comhlíonadh oibleagáidí urraitheora sna nósanna imeachta maidir le húdarú atá leagtha amach i gCaibidil II agus i gCaibidil III;
a sponsor responsible for compliance with the obligations of a sponsor in the authorisation procedures set out in Chapters II and III;
#641502
urraitheoir atá freagrach as na bearta arna nglacadh i gcomhréir hAirteagal 77 a chur chun feidhme.
a sponsor responsible for implementing the measures taken in accordance with Article 77.
#641508
Ionadaí dlíthiúil an urraitheora san Aontas
Legal representative of the sponsor in the Union
#641509
I gcás nach mbeidh urraitheoir trialach cliniciúla bunaithe san Aontas, áiritheoidh an t-urraitheoir go mbeidh duine nádúrtha nó dlítheanach bunaithe san Aontas mar a ionadaí dlíthiúil.
Where the sponsor of a clinical trial is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.
#641511
Measfar aon chumarsáid leis an ionadaí dlíthiúil sin mar chumarsáid leis an urraitheoir.
Any communication to that legal representative shall be deemed to be a communication to the sponsor.
#641516
Ní dhéanfaidh an Chaibidil seo difear do dhliteanas sibhialta ná coiriúil an urraitheora, an imscrúdaitheora, nó aon duine a dtarmligfidh an t-urraitheoir cúram chuige.
This Chapter shall not affect the civil and criminal liability of the sponsor, investigator, or persons to whom the sponsor has delegated tasks.
#641531
a cheangal ar an urraitheoir aon ghné den triail chliniciúil a mhodhnú.
require the sponsor to modify any aspect of the clinical trial.
#641728
Déanfaidh an t-urraitheoir, i gcás inarb iomchuí, tagairt d'aon iarratais roimhe seo.
The sponsor shall, where appropriate, refer to any previous applications.
#641729
Más urraitheoir eile a chuir na hiarratais sin isteach, cuirfear an comhaontú i scríbhinn ón urraitheoir sin isteach freisin.
If these applications have been submitted by another sponsor, the written agreement from that sponsor shall be submitted.
#641732
Dearbhóidh an síniú go bhfuil an t-urraitheoir deimhin den méid seo a leanas:
This signature confirms that the sponsor is satisfied that:
#641820
teagmhais dhíobhálacha thromchúiseacha nach gá don imscrúdaitheoir a thuairisciú láithreach don urraitheoir.
serious adverse events which do not require immediate reporting by the investigator to the sponsor.
#641824
tuairisciú frithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta ag an urraitheoir chuig bunachar sonraí Eudravigilance;
reporting of suspected unexpected serious adverse reactions by the sponsor to the Eudravigilance database;
#641959
Cuirfear isteach tuairisc ar aon chomhaontú eile idir an t-urraitheoir agus an láthair.
Description of any other agreement between the sponsor and the site shall be submitted.
#641968
Dearbhófar leis an síniú sin gur deimhin leis an urraitheoir an méid seo a leanas:
This signature shall confirm that the sponsor is satisfied that:
#641998
TUAIRISCIÚ ÓN IMSCRÚDAITHEOIR CHUIG AN URRAITHEOIR MAIDIR LE TEAGMHAIS DHÍOBHÁLACHA THROMCHÚISEACHA
REPORTING OF SERIOUS ADVERSE EVENTS BY THE INVESTIGATOR TO THE SPONSOR
#642005
Ní dhéanfaidh an t-urraitheoir an measúnú ar chúisíocht a íosghrádú.
The causality assessment given by the investigator shall not be downgraded by the sponsor.
#642006
Mura n-aontóidh an t-urraitheoir le measúnú an imscrúdaitheora ar an gcúisíocht, cuirfear tuairimí an imscrúdaitheora agus an urraitheora araon ar fáil sa tuarascáil.
If the sponsor disagrees with the investigator's causality assessment, the opinion of both the investigator and the sponsor shall be provided with the report.
#642009
Leagfaidh an t-urraitheoir amach intuarthacht frithghnímh dhíobhálaigh san FTS.
The expectedness of an adverse reaction shall be set out by the sponsor in the RSI.
#642022
uimhir staidéir urraitheora;
a sponsor study number;
#642040
Cuirfidh an t-urraitheoir tuarascáil iomlánaithe isteach laistigh d'ocht lá breise.
The sponsor shall submit a completed report within an additional eight days.
#642051
TUAIRISCIÚ BLIANTÚIL ÓN URRAITHEOIR MAIDIR LE SÁBHÁILTEACHT
ANNUAL SAFETY REPORTING BY THE SPONSOR
#642063
Sonraí an urraitheora (lena n-áirítear pointí teagmhála eolaíocha agus poiblí);
Sponsor details (including scientific and public contact points);.
#642097
Ainm agus sonraí teagmhála an urraitheora;
Name and contact details of the sponsor;
#642147
cód tagartha trialach cliniciúla lenar féidir láthair na trialach, an t-imscrúdaitheoir, an t-urraitheoir agus an duine is ábhar a aithint.
clinical trial reference code allowing identification of the clinical trial site, investigator, sponsor and subject;