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15 results in 5 documents

  1. #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;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  2. #641903

    tar éis modhnú (mar shampla dalladh)

    after modification (for example blinding)

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  3. #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;

    Commission Implementing Regulation (EU) 2021/646 of 19 April 2021 laying down rules for the application of Regulation (EU) 2019/2144 of the European Parliament and of the Council as regards uniform procedures and technical specifications for the type-approval of motor vehicles with regard to their emergency lane-keeping systems (ELKS) (Text with EEA relevance)

  4. #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;

    Commission Implementing Regulation (EU) 2021/646 of 19 April 2021 laying down rules for the application of Regulation (EU) 2019/2144 of the European Parliament and of the Council as regards uniform procedures and technical specifications for the type-approval of motor vehicles with regard to their emergency lane-keeping systems (ELKS) (Text with EEA relevance)

  5. #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.

    Commission Implementing Regulation (EU) 2021/646 of 19 April 2021 laying down rules for the application of Regulation (EU) 2019/2144 of the European Parliament and of the Council as regards uniform procedures and technical specifications for the type-approval of motor vehicles with regard to their emergency lane-keeping systems (ELKS) (Text with EEA relevance)

  6. #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);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  7. #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;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  8. #642070

    Earcaíocht (lena n-áirítear faisnéis maidir le líon na ndaoine is ábhar a ndéantar scagthástáil orthu, a earcaítear agus a tharraingítear siar; critéir iniata agus eisiata; sonraí randamúcháin agus dallta; táirgí íocshláinte imscrúdaitheacha a úsáidtear);

    Recruitment (including information on the number of subjects screened, recruited and withdrawn; inclusion and exclusion criteria; randomisation and blinding details; investigational medicinal products used);

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  9. #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.

    Regulation (EU) 2022/1034 of the European Parliament and of the Council of 29 June 2022 amending Regulation (EU) 2021/953 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic (Text with EEA relevance)

  10. #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.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  11. #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;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  12. #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;

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance

  13. #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;

    Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

  14. #1984374

    Prótacal I maidir le Mionghiotaí Do-bhraite (118 nArdpháirtí Chonarthacha), Prótacal Leasaithe II maidir le Toirmisc nó Srianta ar Úsáid Mianach, Bobghaistí agus Feistí Eile, arna leasú an 3 Bealtaine 1996 (106 Ardpháirtí Chonarthacha), Prótacal III maidir le Toirmisc nó Srianta ar Úsáid Armán Loiscneach (115 Ard-Pháirtí Chonarthacha), Prótacal IV um airm léasair dhalltacha (109 nArd-Pháirtí Chonarthacha) agus Prótacal V maidir le Fuílligh Pléascacha Chogaidh (96 Ard-Pháirtí Chonarthacha).

    rotocol I on Non-detectable Fragments (118 High Contracting Parties), Amended Protocol II on Prohibitions or Restrictions on the Use of Mines, Booby-Traps and Other Devices, as amended on 3 May 1996 (106 High Contracting Parties), Protocol III on Prohibitions or Restrictions on the Use of Incendiary Weapons (115 High Contracting Parties), Protocol IV on Blinding Laser Weapons (109 High Contracting Parties) and Protocol V on Explosive Remnants of War (96 High Contracting Parties).

    Council Decision (CFSP) 2021/1694 of 21 September 2021 in support of the universalisation, implementation and strengthening of the Convention on Prohibitions or Restrictions on the Use of Certain Conventional Weapons Which May Be Deemed to Be Excessively Injurious or to Have Indiscriminate Effects (CCW)

  15. #1984379

    Go háirithe, leis an tsolúbthacht sin, bhíothas in ann prótacail nua a chur leis an gCoinbhinsiún – Prótacal IV um airm léasair dhalltacha in 1996 agus Prótacal V maidir le fuílligh phléascacha chogaidh in 2003 – a cuireadh leis na trí phrótacal bhunaidh a glacadh in 1980.

    In particular, this flexibility has allowed the Convention to add new protocols – Protocol IV on blinding laser weapons in 1996 and Protocol V on explosive remnants of war in 2003 – to the original three that were adopted in 1980.

    Council Decision (CFSP) 2021/1694 of 21 September 2021 in support of the universalisation, implementation and strengthening of the Convention on Prohibitions or Restrictions on the Use of Certain Conventional Weapons Which May Be Deemed to Be Excessively Injurious or to Have Indiscriminate Effects (CCW)