#641903
tar éis modhnú (mar shampla dalladh)
after modification (for example blinding)
Scag na torthaí
Bailiúcháin
16 toradh in 5 dhoiciméad
#3117590
Cumas stróbascópaí le dalladh léis nó stróbáil bhrathadóireachta;
Stroboscopic capability with either beam blanking or detector strobing;
#640825
Ciallaíonn “monaraíocht” monaraíocht iomlán nó pháirteach, chomh maith leis na próisis éagsúla lena ndéantar roinnt, pacáistiú agus lipéadú (lena n-áirítear dalladh);
‘Manufacturing’ means total and partial manufacture, as well as the various processes of dividing up, packaging and labelling (including blinding);
#641782
tuairisc ar na bearta a bheidh glactha chun claonadh a íoslaghdú, lena n-áirítear, más infheidhme, randamúchán agus dalladh;
a description of the measures taken to minimise bias, including, if applicable, randomisation and blinding;
#641804
tuairisc ar na nósanna imeachta cuntasachta chun táirgí íocshláinte a sholáthar agus a riar do dhaoine is ábhar lena n-áirítear leanúint den dalladh, más infheidhme;
a description of the accountability procedures for the supply and administration of medicinal products to subjects including the maintenance of blinding, if applicable;
#642045
Más FDTNA ionchasach teagmhas, is é an t-urraitheoir amháin a dhéanfaidh an dalladh a bhriseadh don duine is ábhar sin.
If an event is potentially a SUSAR the blind shall be broken for that subject only by the sponsor.
#2030318
i ngach staid soilsithe agus na braiteoirí gan dalladh (e.g. a ndalladh de sholas na gréine) i dteannta le ceannlampaí tardhula (ceannlampaí léis mhaolaithe) gníomhachtaithe a bheith ann más gá;
in all illumination conditions without blinding of the sensors (e.g. direct blinding due to sunlight) and with activated passing-beam (dipped-beam) headlamps if necessary;
#2030341
i ngach staid soilsithe agus na braiteoirí gan dalladh (e.g. a ndalladh de sholas na gréine) i dteannta le ceannlampaí tardhula (ceannlampaí léis mhaolaithe) gníomhachtaithe a bheith ann más gá;
in all illumination conditions without blinding of the sensors (e.g. direct blinding sunlight) and with activated passing-beam (dipped-beam) headlamps if necessary;
#2030366
I ndálaí soilsis chomhthimpeallaigh 2000 Lux ar a laghad agus na braiteoiri gan dalladh (e.g. a ndalladh de sholas na gréine) i dteannta le ceannlampaí tardhula gníomhachtaithe a bheith ann más gá.
In ambient illumination conditions of at least 2000 lux without blinding of the sensors (e.g. direct blinding sunlight) and with activated low beam head lamps if necessary.
#2469673
Ina theannta sin, ba cheart sláine na dtrialacha cliniciúla, lena n-áirítear ó thaobh dalladh sonraí agus rúndacht sonraí de, a chaomhnú chun bailíocht na dtorthaí a áirithiú.
In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results.
#640707
I gcás inar cuireadh an táirge íocshláinte imscrúdaithe nó cúnta ar an margadh cheana mar tháirge íocshláinte údaraithe i gcomhréir le Treoir 2001/83/CE agus le Rialachán (CE) Uimh.726/2004 ó Pharlaimint na hEorpa agus ón gComhairle(6), ní cheanglaítear, mar riail ghinearálta, aon lipéadú breise a bheith ann i gcás trialacha cliniciúla nach bhfuil baint ag dalladh an lipéid leo.
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.
#642046
Coinneofar an dalladh i gcás daoine eile atá freagrach as stiúradh leanúnach na trialach cliniciúla (amhail an bhainistíocht, monatóirí, imscrúdaitheoirí) agus na ndaoine sin atá freagrach as anailís a dhéanamh ar shonraí agus as na torthaí a léirmhíniú ag conclúid na trialach cliniciúla, amhail pearsanra bithmhéadrachta.
The blind shall be maintained for other persons responsible for the ongoing conduct of the clinical trial (such as the management, monitors, investigators) and those persons responsible for data analysis and interpretation of results at the conclusion of the clinical trial, such as biometrics personnel.
#642048
I gcás trialacha cliniciúla a chuirfear i gcrích i ngalar ardghalrachta nó ardmhortlaíochta, áfach, más rud é go bhféadfadh sé gur FDTNA-anna iad críochphointí éifeachtúlachta nó inar mortlaíocht nó toradh “tromchúiseach” eile (a fhéadfar a thuairisciú go hionchasach mar FDTNA) an críochphointe éifeachtúlachta i dtriail chliniciúil, féadfar sláine na trialach cliniciúla a chur i mbaol má bhristear an dalladh go córasach.
However, for clinial trials carried out in high morbidity or high mortality disease, where efficacy end-points could also be SUSARs or when mortality or another 'serious' outcome, that may potentially be reported as a SUSAR, is the efficacy end-point in a clinical trial, the integrity of the clinical trial may be compromised if the blind is systematically broken.
#642131
foirm an chógais, an bealach a ndéantar é a riar (féadfar é seo a eisiamh i gcás foirmeacha dáileoige soladacha a ghlactar ó bhéal), líon na n-aonad dáileoige agus, i gcás trialacha cliniciúla nach bhfuil baint acu le dalladh an lipéid, ainm/aitheantóir agus dáileog/cumhacht;
pharmaceutical form, route of administration (may be excluded for oral solid dose forms), quantity of dosage units and, in the case of clinical trials which do not involve the blinding of the label, the name/identifier and strength/potency;
#642137
an bealach a ndéantar é a riar (féadfar é a eisiamh i gcás foirmeacha dáileoige soladacha a ghlactar ó bhéal) agus, i gcás trialacha cliniciúla nach bhfuil baint acu le dalladh an lipéid oscailte, ainm/aitheantóir agus dáileog/cumhacht;
route of administration (may be excluded for oral solid dose forms) and, in the case of clinical trials which do not involve the blinding of the label, the name/identifier and strength/potency;
#1736022
sonraí an phrótacail maidir le triail chliniciúil ina dtugtar tuairisc ar na modhanna a úsáideadh, lena n-áirítear modhanna randamúcháin agus dalladh, sonraí cosúil le bealach na tabhartha, an sceideal don tabhairt, an dáileog, sainaithint ainmhithe trialach, speiceas, pórtha nó tréithchineál, aois, meáchan, gnéas, stádas fiseolaíoch;
details of the clinical trial protocol giving a description of the methods used, including methods of randomisation and blinding, details such as the route of administration, schedule of administration, the dose, identification of trial animals, species, breeds or strains, age, weight, sex, physiological status;