#629114
gaireas trialach inniúlachta siceolaíche
psychological aptitude-testing apparatus
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#640666
I gcomhréir le caighdeáin idirnáisiúnta, ba cheart torthaí na trialach cliniciúla a thuairisciú laistigh d'aon bhliain amháin ó dheireadh na trialach cliniciúla.
In accordance with international standards, the results of the clinical trial should be reported within one year from the end of the clinical trial.
#640678
Agus raon an fhaireacháin á shuí, ba cheart saintréithe na trialach cliniciúla a chur san áireamh.
When establishing the extent of monitoring, the characteristics of the clinical trial should be taken into account.
#640682
Le linn trialach cliniciúla, d'fhéadfadh sé go gcuirfí urraitheoir ar an eolas faoi sháruithe tromchúiseacha ar na rialacha maidir le stiúradh na trialach cliniciúla sin.
During a clinical trial, a sponsor may become aware of serious breaches of the rules for the conduct of that clinical trial.
#640692
Ba cheart máistirchomhad na trialach cliniciúla a chartlannú go hiomchuí chun go bhféadfaí maoirseacht a dhéanamh tar éis dheireadh na trialach cliniciúla.
The clinical trial master file should be archived appropriately to allow for supervision after the clinical trial has ended.
#640696
Ar na táirgí íocshláinte sin, áirítear táirgí íocshláinte a úsáidtear i gcomhthéacs trialach cliniciúla.
Such medicinal products include medicinal products used in the context of a clinical trial.
#640733
Sa bhreis air sin, níor cheart tríd is tríd go ndéanfaí príomh-shaintréithe na trialach cliniciúla, an chonclúid maidir le Cuid I den tuarascáil mheasúnaithe maidir le húdarú do thriail chliniciúil agus an cinneadh maidir le húdarú na trialach cliniciúla, an modhnú substaintiúil ar an triail chliniciúil agus torthaí na trialach cliniciúla, lena n-áirítear na cúiseanna lena stopadh go sealadach agus lena fhoirceannadh go luath, a mheas mar nithe rúnda.
In addition, the main characteristics of a clinical trial, the conclusion on Part I of the assessment report for the authorisation of a clinical trial, the decision on the authorisation of a clinical trial, the substantial modification of a clinical trial, and the clinical trial results including reasons for temporary halt and early termination, in general, should not be considered confidential.
#640799
de réir phrótacal na trialach cliniciúla,
according to the protocol of the clinical trial,
#640815
Ciallaíonn “imscrúdaitheoir” duine aonair atá freagrach as triail chliniciúil a stiúradh ag láithreán trialach cliniciúla;
‘Investigator’ means an individual responsible for the conduct of a clinical trial at a clinical trial site;
#640822
Ciallaíonn “prótacal” doiciméad ina dtugtar tuairisc ar chuspóirí, dearadh, modheolaíocht, gnéithe staidrimh agus eagrúchán trialach cliniciúla.
‘Protocol’ means a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial.
#640826
Ciallaíonn “tús na trialach cliniciúla” an chéad ghníomh chun duine is ábhar ionchasach a earcú le haghaidh trialach cliniciúil sonraí, mura rud é go sainmhínítear ar bhealach éagsúil é sa phrótacal;
‘Start of a clinical trial’ means the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol;
#640828
Ciallaíonn “luathfhoirceannadh na trialach cliniciúla” deireadh anabaí trialach cliniciúla i ngeall ar chúis ar bith sula mbeidh na coinníollacha a shonraítear sa phrótacal comhlíonta;
‘Early termination of a clinical trial’ means the premature end of a clinical trial due to any reason before the conditions specified in the protocol are complied with;
#640891
tá stiúradh na trialach cliniciúla inghlactha i bhfianaise na gceanglas a leagtar amach sa Rialachán seo;
the conduct of the clinical trial is acceptable in view of the requirements set out in this Regulation;
#640893
níl stiúradh na trialach cliniciúla inghlactha i bhfianaise na gceanglas a leagtar amach sa Rialachán seo.
the conduct of the clinical trial is not acceptable in view of the requirements set out in this Regulation.
#640981
Measfar an t-iarratas sin mar iarratas nua ar údarú trialach cliniciúla eile.
That application shall be deemed to be a new application for authorisation of another clinical trial.
#641113
stiúradh na trialach cliniciúla, lena n-áirítear an comhthéacs eolaíoch agus na socruithe atá déanta;
the conduct of the clinical trial, including the scientific context and arrangements taken,
#641120
tagairt don triail chliniciúil nó do na trialacha cliniciúla atáthar a mhodhnú go substaintiúil ag úsáid uimhir trialach AE dá dtagraítear sa tríú fomhír d'Airteagal 81(1) (“uimhir trialach AE”);
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’);
#641166
nádúr, cuspóirí, rioscaí agus míchaoithiúlachtaí na trialach cliniciúla;
the nature, objectives, benefits, implications, risks and inconveniences of the clinical trial;
#641173
beidh ar áireamh san fhaisnéis sin uimhir trialach AE, agus faisnéis faoi infhaightheacht thorthaí na trialach cliniciúla i gcomhréir le mír 6.
include the EU trial number and information about the availability of the clinical trial results in accordance with paragraph 6.
#641249
Fógra maidir le tús trialach cliniciúla agus maidir le deireadh earcú na ndaoine is ábhar
Notification of the start of a clinical trial and of the end of the recruitment of subjects
#641265
Gan aird a thabhairt ar thoradh na trialach cliniciúla, laistigh de bhliain ó dheireadh trialach cliniciúla sna Ballstáit uile lena mbaineann, cuirfidh an t-urraitheoir achoimre ar thorthaí na trialach cliniciúla isteach i mbunachar sonraí AE.
Irrespective of the outcome of a clinical trial, within one year from the end of a clinical trial in all Member States concerned, the sponsor shall submit to the EU database a summary of the results of the clinical trial.
#641278
I gcás ina bhfoirceannfar na trialach cliniciúla go luath, is é dáta an fhoirceannta luaith sin a mheasfar mar dheireadh na trialach cliniciúla.
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.
#641280
Gan dochar do mhír 4, i gcás ina mbeidh foráil i bprótacal na trialach cliniciúla maidir le dáta idirmheánach anailís ar shonraí roimh dheireadh na trialach cliniciúla, agus i gcás ina mbeidh torthaí na trialach cliniciúla faoi seach ar fáil, cuirfear achoimre ar na torthaí sin isteach i mbunachar sonraí AE laistigh d'aon bhliain amháin den dáta idirmheánach anailís ar shonraí.
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.
#641291
TUAIRISCIÚ MAIDIR LE SÁBHÁILTEACHT I GCOMHTHÉACS TRIALACH CLINICIÚLA
SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL
#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.
#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
#641358
cuspóir agus modheolaíocht na trialach cliniciúla;
the objective and methodology of the clinical trial;
#641361
Oiriúnacht daoine aonair atá páirteach i stiúradh na trialach cliniciúla
Suitability of individuals involved in conducting the clinical trial
#641365
Oiriúnacht láithreán trialach cliniciúil
Suitability of clinical trial sites
#641398
Máistirchomhad trialach cliniciúla
Clinical trial master file
#641399
Coinneoidh an t-urraitheoir agus an t-imscrúdaitheoir máistirchomhad trialach cliniciúla.
The sponsor and the investigator shall keep a clinical trial master file.
#641400
Beidh sa mháistirchomhad trialach cliniciúla i gcónaí na doiciméid bunriachtanacha a bhaineann leis an triail chliniciúil a chuireann ar chumas fíorú a dhéanamh ar stiúradh na trialach cliniciúla agus ar chaighdeán na sonraí a ghintear, ag cur saintréithe ar fad na trialach cliniciúla san áireamh, lena n-áirítear go háirithe más triail chliniciúil idirghabhála ísle í an triail chliniciúil.
The clinical trial master file shall at all times contain the essential documents relating to that clinical trial which allow verification of the conduct of a clinical trial and the quality of the data generated, taking into account all characteristics of the clinical trial, including in particular whether the clinical trial is a low-intervention clinical trial.
#641404
An máistirchomhad trialach cliniciúla a chartlannú
Archiving of the clinical trial master file
#641408
Déanfar aon aistriú úinéireachta ar inneachar an mháistirchomhad trialach cliniciúla a dhoiciméadú.
Any transfer of ownership of the content of the clinical trial master file shall be documented.
#641413
Beidh aon athrú ar inneachar an mháistirchomhaid trialach cliniciúla inrianaithe.
Any alteration to the content of the clinical trial master file shall be traceable.
#641505
Áiritheoidh an príomh-imscrúdaitheoir go gcomhlíonfaidh triail chliniciúil ag suíomh na trialach cliniciúla ceanglais an Rialacháin.
A principal investigator shall ensure compliance of a clinical trial at a clinical trial site with the requirements of this Regulation.
#641570
Déanfaidh bunachar sonraí AE gach triail chliniciúil a shainaithint trí uimhir trialach uathúil AE.
The EU database shall identify each clinical trial by a unique EU trial number.
#641586
maoirseacht éifeachtach a áirithiú maidir le stiúradh trialach cliniciúla ag na Ballstáit.
ensuring effective supervision of the conduct of a clinical trial by Member States.
#641740
Déanfaidh an litir chumhdaigh uimhir trialach AE agus an uimhir trialach uilíoch a shonrú agus aird a tarraingt ar aon ghnéithe atá sonrach don triail chliniciúil.
The cover letter shall specify the EU trial number and the universal trial number and shall draw attention to any features which are particular to the clinical trial.
#641761
teideal na trialach cliniciúla;
the title of the clinical trial;
#641793
cumhacht na trialach cliniciúla agus ábharthacht chliniciúil a ríomh;
calculations of the power of the clinical trial and clinical relevance;
#641806
tuairisc ar shocruithe chun faireachán a dhéanamh ar stiúradh na trialach cliniciúla;
a description of arrangements for monitoring the conduct of the clinical trial;
#641957
Tuairisc ghairid ar mhaoiniú na trialach cliniciúla.
A brief description of the financing of the clinical trial.
#642014
Féadfar an FTS a athrú le linn stiúradh trialach cliniciúla a stiúradh.
The RSI may change during the conduct of a clinical trial.
#642021
uimhir trialach AE bailí;
a valid EU trial number;
#642058
INNEACHAR NA HACHOIMRE AR THORTHAÍ NA TRIALACH CLINICIÚLA
CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL
#642059
Beidh san achoimre ar thorthaí na trialach cliniciúla faisnéis ar na gnéithe seo a leanas:
The summary of the results of the clinical trial shall contain information on the following elements:
#642060
A.FAISNÉIS NA TRIALACH CLINICIÚLA
A.CLINICAL TRIAL INFORMATION:
#642062
Aitheantóirí (lena n-áirítear uimhir trialach AE, aitheantóirí eile);
Identifiers (including EU trial number, other identifiers);
#642067
Faisnéis ghinearálta faoin triail chliniciúil (lena n-áirítear faisnéis faoi phríomhchuspóirí na trialach, faoi dhearadh trialach, faoi chúlra eolaíoch agus faoi mhíniú na réasúnaíochta don triail; dáta thús na trialach, bearta arna nglacadh maidir le cosaint daoine is ábhar, teiripe cúlra; agus modhanna staidrimh a úsáidtear);
General information about the clinical trial (including information about main objectives of the trial, trial design, scientific background and explanation of rationale for the trial; date of the start of the trial, measures of protection of subjects taken, background therapy; and statistical methods used);