Gaois

This is a static copy of data that is exported from IATE on an occasional basis. It should not be assumed that information provided about an entry here will always correspond to the current version of the entry in IATE. That current version can be checked by clicking on the link on the upper right hand side of each entry. More information »

27 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #634610

    IATE #1686971
    triail chliniciúil Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:32014R0536/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Definition staidéar cliniciúil a chomhlíonann aon cheann de na coinníollacha seo a leanas: (a) déantar an cinneadh maidir leis an duine is ábhar a shannadh do straitéis theiripeach áirithe roimh ré agus ní thagann sé faoi ghnáthchleachtas cliniciúil an Bhallstáit lena mbaineann; (b) déantar an cinneadh maidir le táirgí íocshláinte imscrúdaitheacha a ordú in éineacht leis an gcinneadh maidir leis an duine is ábhar a áireamh sa staidéar cliniciúil; nó (c) déantar nósanna imeachta diagnóiseacha nó faireacháin sa bhreis ar an ngnáthchleachtas cliniciúil a chur i bhfeidhm maidir leis na daoine is ábhar Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:32014R0536/GA"
    klinische Prüfung
    de
    Definition "klinische Studie [IATE:3543172], die mindestens eine der folgenden Bedingungen erfüllt:a) Der Prüfungsteilnehmer wird vorab einer bestimmten Behandlungsstrategie zugewiesen, die nicht der normalen klinischen Praxis des betroffenen Mitgliedstaats entspricht;b) die Entscheidung, die Prüfpräparate zu verschreiben, wird zusammen mit der Entscheidung getroffen, den Prüfungsteilnehmer in die klinische Studie aufzunehmen, oder c) an den Prüfungsteilnehmern werden diagnostische oder Überwachungsverfahren angewendet, die über die normale klinische Praxis hinausgehen" Reference "Verordnung (EU) Nr. 536/2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG CELEX:32014R0536/DE"
    clinical trial
    en
    Definition "clinical study which fulfils any of the following conditions:(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the country concerned;(b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or(c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects" Reference "COM-EN, based on: Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, consolidated version 27.5.2014"
    Comment Clinical trials are used to determine whether new drugs or treatments are both safe and effective. They are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.
    essai clinique
    fr
    Definition étude clinique remplissant l'une des conditions suivantes:a) l'affectation du participant à une stratégie thérapeutique en particulier est fixée à l'avance et ne relève pas de la pratique clinique normale de l'État membre concerné;b) la décision de prescrire les médicaments expérimentaux est prise en même temps que la décision d'intégrer le participant à l'essai clinique; ou c) outre la pratique clinique normale, des procédures de diagnostic ou de surveillance s'appliquent aux participants Reference "Règlement (UE) n° 536/2014 relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE, art. 2, par. 2, point 2), CELEX:32014R0536/FR"
    Comment "Voir aussi: étude clinique [IATE:3543172 ]"
  2. SOCIAL QUESTIONS|health|pharmaceutical industry|veterinary medicinal product

    #651710

    IATE #3555178
    triail chliniciúil allamuigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    triail allamuigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinischer Feldversuch
    de
    clinical trial | clinical field trial | veterinary field trial | field trial
    en
    Definition "study which aims to examine under field conditions the safety or efficacy of a veterinary medicinal product under normal conditions of animal husbandry or as part of normal veterinary practice for the purpose of obtaining a marketing authorisation or a change thereof" Reference "Regulation (EU) 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC"
    essai clinique de terrain
    fr
    Definition essai clinique visant à éprouver l'efficacité ou l'innocuité d'un médicament vétérinaire sur l'espèce cible et dans des conditions d'utilisation réelles Reference COM-FR
  3. SOCIAL QUESTIONS|health|pharmaceutical industry

    #658859

    IATE #3574880
    triail chliniciúil dearaidh oiriúnaithigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    triail oiriúnaitheach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    adaptive klinische Prüfung
    de
    adaptive design clinical trial | adaptive design clinical study | adaptive clinical trial | adaptive trial
    en
    Definition clinical trial that includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study Reference "COM-EN, based on:J.R. Yates, J. Seoane, C. Le Tourneau et al., 'Precision Medicine Glossary', European Society for Medical Oncology: Annals of Oncology, Vol. 29, Issue 1, p.30-35, 1 January 2018. "
    Comment The term prospective here means that the adaptation was planned (and details specified) before data were examined in an unblinded manner by any personnel involved in planning the revision.
    essai clinique adaptatif | essai clinique de type adaptatif | essai adaptatif | schéma adaptatif | design adaptatif | stratégie adaptative
    fr
    Definition essai clinique dans le cadre duquel les données accumulées permettent de modifier et d’adapter certains aspects de l’étude au cours du temps (nombre de patients, dose et durée du traitement, fréquence des analyses, critères d’évaluation, etc.) afin de rendre l’essai plus précis et efficace Reference "COM-FR, d’après: 1. le site BioPharmAnalyses, «Design adaptatif: un concept qui se prête bien aux besoins médicaux non couverts» (23.4.2020), A.-L. Berthier2. le site du laboratoire Roche > Les chercheurs de Roche réveillent le système immunitaire > Découverte: les essais cliniques s’adaptent (23.4.2020)"
    Comment "Voir aussi: -
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #657567

    IATE #3571928
    sainchomhad iarratais ar thrialacha cliniciúla Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    sainchomhad iarratais Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Trí na nósanna imeachta nua maidir le húdarú trialacha cliniciúla, ba cheart taobhú leis an méid Ballstát agus is féidir a áireamh. Dá bhrí sin, ar mhaithe leis na nósanna imeachta a shimpliú maidir le tíolacadh sainchomhaid iarratais i dtaca le húdarú do thriail chliniciúil, ba cheart go seachnófaí faisnéis atá mar an gcéanna den chuid is mó a chur isteach arís agus arís eile agus ina ionad sin ba cheart aon sainchomhad iarratais amháin a chur isteach chuig na Ballstáit uile lena mbaineann trí thairseach tíolactha iarratais. I bhfianaise go bhfuil an tábhacht chéanna do thaighde cliniciúil Eorpach ag baint le trialacha cliniciúla a dhéantar i mBallstát aonair, ba cheart go ndéanfaí an sainchomhad iarratais do na trialacha cliniciúla sin a chur isteach freisin tríd an tairseach aonair sin.' Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:32014R0536/GA"
    Antragsdossier für die klinische Prüfung | Antragsdossier
    de
    Definition "Unterlagen, die der Sponsor den betroffenen Mitgliedstaaten seiner Wahl über das EU-Portal übermittelt, um eine Genehmigung für die Durchführung einer klinischen Prüfung zu erhalten" Reference "COM-DE nach: Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG Text von Bedeutung für den EWR"
    clinical trial application dossier | CTA dossier | application dossier | application dossier for the authorisation of a clinical trial
    en
    Definition "collection of documents that must be submitted by the sponsor through the EU clinical trial portal to the intended Member States concerned in order to obtain an authorisation to conduct a clinical trial" Reference "COM-Terminology Coordination, based on: - Articles 5(1) and 80 of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use- European Medicines Agency. 'The EU clinical trial portal and database' (4.11.2020)"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #676845

    IATE #930980
    críochphointe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    críochphointe cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Endpunkt
    de
    Definition festgelegtes Ziel einer klinischen Studie, anhand dessen festgestellt wird, ob eine angewendete Maßnahme (i.d.R. eine medizinische Behandlung) erfolgreich war Reference "vgl. Wikipedia http://de.wikipedia.org/wiki/Prim%C3%A4rer_Endpunkt (13.10.2009)"
    Comment "Es wird unterschieden zwischen primären Endpunkten (Hauptziel einer Studie - z.B. Überlebensrate oder Rückfallrisiko, i.d.R. messbare Größen) und sekundären Endpunkten (zweitrangiges Ziel einer Studie, oftmals nicht messbare Größen wie Schmerzen, Lebensqualität). [ vgl. Wikipedia http://de.wikipedia.org/wiki/Sekund%C3%A4rer_Endpunkt , 13.10.2009]"
    clinical endpoint | clinical trial endpoint | endpoint | end point | end-point
    en
    Definition clinically relevant outcome, accepted in medical practice (e.g. by regulatory guidance or professional society guidelines) and sufficiently sensitive and specific to detect the anticipated effect of the treatment Reference "COM-Terminology Coordination, based on:European Medicines Agency (EMA). 'ICH guideline E17 on general principles for planning and design of multi-regional clinical trials Step 5' (14.12.2023)"
    Comment "A clinical trial might use a clinical endpoint or a surrogate endpoint. A clinical endpoint is an outcome that represents direct clinical benefit, such as survival, decreased pain, or the absence of disease."
    critère d'évaluation principal | critère d'efficacité | critère de jugement
    fr
    Definition paramètre par lequel on évalue, au cours d'un essai clinique, les effets d'une intervention thérapeutique chez des sujets Reference "Office québecois de la langue française > Grand dictionnaire terminologique > critère d'évaluation (21.9.2023)"
  6. SOCIAL QUESTIONS|health|pharmaceutical industry

    #623160

    IATE #1237287
    imscrúdaitheoir Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfer | klinischer Prüfer
    de
    Definition Person, die für die Durchführung der klinischen Prüfung in einer Prüfstelle verantwortlich ist Reference "Richtlinie 2001/20/EG zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln CELEX:32001L0020/DE Verordnung (EU) Nr. 536/2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG, Art.2 Nr.15; ABl. L_158/2014, S.1 CELEX:32014R0536/DE"
    investigator | clinical trial investigator | clinical trial investigators | clinical investigator
    en
    Definition individual responsible for the conduct of a clinical trial at a clinical trial site Reference "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)Text with EEA relevance"
    Comment "The term 'investigator' also appears in Regulation (EU) 2017/745 on medical devices and in Regulation (EU) 2017/746 on in vitro diagnostic medical devices, with slightly different definitions."
    expérimentateur
    fr
  7. SOCIAL QUESTIONS|health|pharmaceutical industry

    #680600

    IATE #1684021
    prótacal Reference "Togra le haghaidh Rialacháin ó Pharlaimint na hEorpa agus ón gComhairle maidir le trialacha cliniciúla ar tháirgí míochaine lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:52012PC0369/GA ;Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Ionas go n-áiritheofar go gcomhlíonfaidh reáchtáil na trialach cliniciúla an prótacal, agus chun na himscrúdaitheoirí a chur ar an eolas faoi na táirgí míochaine imscrúdaithe a riarann siad, ba cheart don urraitheoir bróisiúr imscrúdaitheora a sholáthar do na himscrúdaitheoirí.' Reference "Togra maidir le trialacha cliniciúla ar tháirgí míochaine lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:52012PC0369/GA"
    prótacal na trialach cliniciúla Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Definition doiciméad ina ndéantar cur síos ar chuspóirí, dearadh, modheolaíocht, gnéithe staidrimh agus eagrúchán trialach cliniciúla Reference "Togra maidir le trialacha cliniciúla ar tháirgí míochaine lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:52012PC0369/GA"
    protocol | clinical trial protocol
    en
    Definition "document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial" Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance"
  8. SOCIAL QUESTIONS|health|pharmaceutical industry

    #685112

    IATE #3580235
    Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, CELEX:2014R0536-20140527/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Clinical Trial Regulation | Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
    en
    Definition 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 Reference "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. SOCIAL QUESTIONS|health|pharmaceutical industry

    #634673

    IATE #1687928
    urraitheoir trialach cliniciúla Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0536/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Déanfaidh urraitheoir trialach cliniciúla a rinneadh i mBallstát amháin ar a laghad gach faisnéis ábhartha maidir leis na frithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta seo a leanas a thuairisciú go leictreonach agus gan mhoill don bhunachar sonraí leictreonach.' Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0536/GA"
    urraitheoir Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0536/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    Context 'Ba cheart a fhoráil sa nós imeachta um údarú gur féidir na hamlínte don mheasúnú a fhadú chun ligean don urraitheoir díriú ar cheisteanna nó barúlacha a ardaítear le linn an mheasúnaithe ar an sainchomhad iarratais. Thairis sin, ba cheart a áirithiú, laistigh den tréimhse fhadaithe, go bhfuil dóthain ama i gcónaí ann chun an fhaisnéis bhreise a cuireadh isteach a mheasúnú.' Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0536/GA"
    Definition duine aonair, cuideachta, institiúid nó eagraíocht a ghlacann freagracht as triail chliniciúil a thionscnamh agus a bhainistiú agus freisin as maoiniú trialach cliniciúla a chur ar bun Reference "Rialachán (AE) Uimh. 536/2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, CELEX:32014R0536/GA"
    Sponsor
    de
    Definition eine Person, ein Unternehmen, eine Einrichtung oder eine Organisation, die bzw. das die Verantwortung für die Einleitung, das Management und die Aufstellung der Finanzierung einer klinischen Prüfung übernimmt Reference "Verordnung (EU) Nr. 536/2014 des Europäischen Parlaments und des Rates vom 16. April 2014 über klinische Prüfungen mit Humanarzneimitteln und zur Aufhebung der Richtlinie 2001/20/EG CELEX:32014R0536/DE"
    sponsor | clinical trial sponsor
    en
    Definition individual, company, institution or organisation which takes responsibility for the initiation, for the management and for setting up the financing of the clinical trial Reference "Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, CELEX:32014R0536/EN"
  10. SOCIAL QUESTIONS|health|pharmaceutical industry

    #644046

    IATE #3518692
    duine is ábhar don tástáil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Proband | Prüfungsteilnehmer | Teilnehmer klinisch Prüfung
    de
    Definition "eine Person, die entweder als Empfänger des Prüfpräparats oder als Mitglied einer Kontrollgruppe an einer klinischen Prüfung IATE:1686971 teilnimmt" Reference "Richtlinie 2001/20/EG zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln CELEX:32001L0020/DE"
    subject | subjects | clinical trial subject | clinical trial subjects
    en
    Definition individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control Reference "Article 2(17) of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC"
    participant à un essai clinique | participant | sujet participant à l'essai
    fr
    Definition personne qui participe à un essai clinique, qu'il reçoive le médicament expérimental ou serve de témoin Reference "Directive 2001/20/CE concernant le rapprochement des dispositions législatives, réglementaires et administratives des États membres relatives à l'application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain"
  12. SOCIAL QUESTIONS|health|pharmaceutical industry · EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research

    #666540

    IATE #3623655
    an Córas Faisnéise maidir le Trialacha Cliniciúla Reference "Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex"
    ga
    CTIS Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Informationssystem für klinische Prüfungen | CTIS
    de
    Definition "System, das von der Europäischen Arzneimittel-Agentur in Zusammenarbeit mit den Mitgliedstaaten und der Europäischen Kommission eingerichtet und gepflegt wird und das zentrale EU-Portal sowie die EU-Datenbank für klinische Prüfungen enthält, die gemäß der Verordnung (EU) Nr. 536/2014 erforderlich sind" Reference "COM-DE nach:European Medicines Agency > Human regulatory > Research and development > Clinical trials > Clinical Trials Regulation (22.12.2021)"
    Clinical Trials Information System | CTIS
    en
    Definition system set up and maintained by the European Medicines Agency, in collaboration with the Member States and the European Commission, which contains the centralised EU portal and database for clinical trials provided for in Regulation (EU) No 536/2014 Reference "COM-Terminology Coordination, based on: EMA (European Medicines Agency). 'Clinical Trials Regulation' (8.12.2021)"
    Comment EU portal (Article 80) and database (Article 81) for clinical trials provided for in Regulation (EU) No 536/2014
  13. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688212

    IATE #3639917
    triail chliniciúil chomparáideach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    vergleichende klinische Prüfung
    de
    comparative clinical trial | comparative trial
    en
    Definition clinical trial comparing two treatments, i.e. two medicinal products, a medicinal product under test and a reference medicinal product Reference "COM-Terminology Coordination, based on: Colin B. Begg and Cyrus R. Mehta. 'Sequential Analysis of Comparative Clinical Trials' (14.12.2023). Biometrika Vol. 66, No. 1 (Apr., 1979), pp. 97-103"
    Comment Possible results are: the medicinal product under test is superior, equivalent or inferior to the reference medicinal product.
    essai clinique comparatif
    fr
    Definition essai permettant de comparer un nouveau médicament, dit « expérimental », avec le médicament utilisé habituellement, dit « de référence » ou « standard » Reference "COM-FR d'aprèsCHU Saint-Etienne > Professionnels > Recherche > Patient > Patient Phases Essais > Recherche clinique (14.12.2023)"
  14. SOCIAL QUESTIONS|health|pharmaceutical industry

    #683580

    IATE #3555177
    triail chliniciúil chóimheasa Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    kontrollierte klinische Prüfung
    de
    controlled clinical trial | CCT
    en
    Definition "clinical trial that includes a control group" Reference "COM-Terminology Coordination, based on: 'controlled clinical trial' (14.6.2023). National Cancer Institute. NCI Dictionary of Cancer Terms"
    Comment "1) The control group receives a placebo, another treatment, or no treatment at all.2) For the different designs, see: Nair B. 'Clinical Trial Designs' (14.6.2023). Indian Dermatol Online J. 2019 Mar-Apr;10(2):193-201. doi: 10.4103/idoj.IDOJ_475_18. PMID: 30984604; PMCID: PMC6434767."
    essai clinique contrôlé
    fr
    Definition essai clinique qui vise à comparer des stratégies thérapeutiques et dont la méthodologie permet de limiter les biais qui pourraient affecter la différence de réponse entre les groupes de personnes comparés Reference "France Terme (Journal officiel du 4.3.2017) > essai clinique contrôlé (14.6.2023)"
    Comment L’essai clinique contrôlé inclut notamment la comparaison d’un groupe de personnes avec un groupe témoin, un tirage au sort déterminant la constitution de ces groupes, ainsi que l’administration du traitement en double aveugle, c’est-à-dire sans que le médecin ni le patient ne connaissent le traitement.
  15. EUROPEAN UNION|EU institutions and European civil service|EU office or agency|European Medicines Agency · SOCIAL QUESTIONS|health|medical science|medical research

    #664288

    IATE #3591654
    tairseach trialacha cliniciúla an Aontais Eorpaigh Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    EU clinical trial portal
    en
    Definition single entry point for submitting clinical trial information in the EU, which will be stored in the database Reference "European Medicines Agency. 'The EU clinical trial portal and database' (4.11.2020)"
    Comment "The Board was updated on the quality and status of the ongoing development of the EU clinical trial portal and database, both of which are being carefully monitored. The Board heard that the development of the auditable release of the portal and database (release 0.7) is complete. The release is now in an intensive phase of pre-testing before formal user acceptance testing (UAT7) can start in early 2019. Taking into account the rate of progress with testing and bug fixing, and the relocation of the Agency, the audit field work will take place once the Agency has settled in Amsterdam, after March 2019. Dependent on successful completion of the audit and review by the Management Board around the end of 2019, the system could be ready to go live later in 2020."
  16. EUROPEAN UNION|European construction|European Union · SOCIAL QUESTIONS|health|medical science · SOCIAL QUESTIONS|health|pharmaceutical industry

    #641513

    IATE #3502438
    EudraCT Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Bunachar Sonraí AE maidir le Trialacha Cliniciúla Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Datenbank über klinische Prüfungen der Europäischen Union | EudraCT
    de
    EU Database on Clinical Trials | European Union clinical trials database | database of clinical trials | clinical trials database | EudraCT | European Clinical Trials Database
    en
    Definition the EU’s electronic database of clinical trials Reference "'Overview of EudraCT'; https://eudract.ema.europa.eu/help/Default.htm [ 18.12.2013 ]"
    Comment "It contains information submitted by sponsors and informs users about ongoing clinical trials in all EU Member States and European Economic Area (EEA) countries, enabling an overview of multi-state trials.See also: clinical trial (related) [ IATE:1686971 ]"
    base de données de l'UE sur les essais cliniques | EudraCT
    fr
  17. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #665636

    IATE #3599551
    clár oibre an Aontais Eorpaigh um thrialacha cliniciúla ilionaid Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    EU-Plattform für multizentrische klinische Prüfungen
    de
    EU platform for multi-centre clinical trials
    en
    Definition flexible, well-resourced platform for multi-centre trials to bring together existing European clinical trial networks for therapeutics and vaccines, making clinical research faster, broader and more effective Reference "COM-EN, based on:- European Commission > Press release > 15 June 2021, Brussels > Emerging stronger from the pandemic: acting on the early lessons learnt (30.9.2021)- European Commission > Questions and answers > 16 September 2021, Brussels > Questions and Answers: European Health Emergency preparedness and Response Authority – HERA (30.9.2021)- Communication from the Commission - Drawing the early lessons from the COVID-19 pandemic, COM(2021) 380"
    plateforme de l’UE pour les essais cliniques multicentriques
    fr
  18. INTERNATIONAL RELATIONS|cooperation policy · SOCIAL QUESTIONS|health · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #615913

    IATE #929310
    an Chomhpháirtíocht maidir le Trialacha Cliniciúla idir Tíortha Eorpacha agus Tíortha i mBéal Forbartha Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    EDCTP Reference Comhairle-GAFaomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Partnerschaft Europas und der Entwicklungsländer im Bereich klinischer Studien | Partnerschaft der europäischen Länder und Entwicklungsländer zur Durchführung klinischer Studien | EDCTP | EDCTP-Programm
    de
    Definition Forschungs- und Entwicklungsprogramm mit dem Ziel, die Entwicklung neuer klinischer Interventionen zur Bekämpfung von HIV/AIDS, Malaria und Tuberkulose in den Entwicklungsländern, insbesondere in Subsahara-Afrika, zu beschleunigen und allgemein die Qualität der diesen Krankheiten gewidmeten Forschung zu verbessern Reference "COM-DE gestützt auf die Mitteilung der Kommission zum Fortschrittsbericht über das Programm „Partnerschaft Europas und der Entwicklungsländer im Bereich klinischer Studien“, KOM/2008/0688 endg."
    Comment Die Partnerschaft wurde als unabhängige Organisation in der Rechtsform einer Europäischen wirtschaftlichen Interessenvereinigung (EWIV) mit Sitz in Den Haag, Niederlande, geschaffen.
    European and Developing Countries Clinical Trials Partnership | EDCTP | European & Developing Countries Clinical Trials Partnership | Innovative Medicines Initiative Programme | IMI2
    en
    Definition partnership between 14 EU countries, Switzerland and Norway, and 47 sub-Saharan African countries, which aims to reduce poverty by developing new clinical interventions to fight HIV/AIDS, malaria and tuberculosis in sub-Saharan Africa Reference "Commission staff working document - Progress made on the Millennium Development Goals and key challenges for the road ahead accompanying the Commission Communication - A twelve-point EU action plan in support of the Millennium Development Goals"
    partenariat des pays européens et en développement sur les essais cliniques | partenariat Europe - Pays en développement pour les essais cliniques | EDCTP | programme EDCTP
    fr
    Definition partenariat créé en 2003 entre 14 pays de l'UE, la Norvège et la Suisse et 47 pays d'Afrique subsaharienne pour lutter contre les trois principales maladies liées à la pauvreté (VIH/sida, malaria et tuberculose), pour mettre en oeuvre un programme de recherche sur le développement de nouveaux produits médicaux, microbicides et vaccins axé sur les essais cliniques de phases II et III et adapté aux besoins spécifiques des pays en développement Reference "Conseil-FR, d'après le site officiel de l'EDCTP, http://www.edctp.org/L_organisation.761.0.html (2.7.2012) et celui de la Commission européenne, http://ec.europa.eu/research/health/infectious-diseases/poverty-diseases/gen-info_fr.html"
  19. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648658

    IATE #3543174
    triail chliniciúil íseal-idirghabhála Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinische Prüfung mit geringfügiger Intervention
    de
    Definition klinische Prüfung, die folgende Bedingungen erfüllt: a) Die Prüfpräparate sind zugelassen; b) die Prüfpräparate sollen dem Prüfplan der klinischen Prüfung zufolge gemäß der im betroffenen Mitgliedstaat geltenden Zulassung verwendet werden oder werden in einem der betroffenen Mitgliedstaaten als Standardbehandlung verwendet; c) die zusätzlichen diagnostischen oder Überwachungsverfahren stellen im Vergleich zur normalen klinischen Praxis in dem betroffenen Mitgliedstaat nur ein geringfügiges zusätzliches Risiko bzw. eine geringfügige zusätzliche Belastung für die Sicherheit der Probanden dar Reference COM-Internes Dokument SANCO-2012-80155-02-01
    low-intervention clinical trial
    en
    Definition "clinical trial [ IATE:1686971 ] which fulfils all of the following conditions:(a) the investigational medicinal products [ IATE:2146586 ] are authorised;(b) according to the protocol of the clinical trial, the investigational medicinal products are used in accordance with the terms of the marketing authorisation or their use is a standard treatment; and(c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice" Reference "COM-EN, based on:Point (3) of the second paragraph of Article 2 of the proposal for a Regulation on clinical trials on medicinal products for human use (COM(2012) 369 final), CELEX:52012PC0369/EN"
    essai clinique à faible intervention
    fr
    Definition "essai clinique [ IATE:1686971 ] obéissant à l’ensemble des conditions suivantes:a) les médicaments expérimentaux sont autorisés;b) selon le protocole de l’étude clinique, les médicaments expérimentaux sont utilisés conformément aux conditions de l’autorisation de mise sur le marché ou leur utilisation constitue un traitement standard;c) les procédures supplémentaires de diagnostic ou de surveillance impliquent au plus un risque ou une contrainte supplémentaire minimale pour la sécurité des participants par rapport à la pratique clinique normale" Reference COM-Document interne: SANCO-2012-80155-00-04Règlement relatif aux essais cliniques de médicaments à usage humain
  20. SOCIAL QUESTIONS|health|pharmaceutical industry · SOCIAL QUESTIONS|health|medical science|medical research

    #663239

    IATE #3589336
    triail chliniciúil randamaithe oiriúnaitheach ilionaid Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    multizentrische adaptive randomisierte klinische Prüfung
    de
    multi-centre adaptive randomised clinical trial
    en
    Definition "clinical trial that is multi-centre, randomised and adaptive" Reference COM-Terminology Coordination
    essai clinique multicentrique, adaptatif et randomisé | essai clinique multicentré, randomisé et adaptatif | essai clinique multicentre, randomisé et adaptatif
    fr
    Comment "Voir aussi:- essai clinique- multicentrique- randomisé- adaptatif"