Gaois

Cóip statach de shonraí a easpórtáiltear ó IATE ó am go chéile atá sa chnuasach seo. Níor cheart glacadh leis gurb ionann i gcónaí an t-eolas a thugtar faoi iontráil anseo agus a bhfuil sa leagan reatha den iontráil ar IATE. Is féidir an leagan reatha sin a cheadú ach cliceáil ar an nasc atá ar thaobh na láimhe deise ag barr gach iontrála. Breis eolais »

3 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #623160

    IATE #1237287
    imscrúdaitheoir Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Prüfer | klinischer Prüfer
    de
    Sainmhíniú Person, die für die Durchführung der klinischen Prüfung in einer Prüfstelle verantwortlich ist Tagairt "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
    Sainmhíniú individual responsible for the conduct of a clinical trial at a clinical trial site Tagairt "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"
    Nóta "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
  2. SOCIAL QUESTIONS|health|medical science

    #602349

    IATE #156803
    bróisiúr imscrúdaitheora Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Information für den Prüfer
    de
    Nóta Term defined --
    investigator's brochure | IB
    en
    Sainmhíniú compilation of the clinical and non-clinical data on the investigational medicinal product or products which provides the investigators and others involved in the trial with information to facilitate their understanding of the rationale for, and their compliance with, key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures Tagairt "COM-EN, based on: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, CELEX:32014R0536/EN"
    brochure pour l'investigateur
    fr
    Nóta Term defined --
  3. SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research

    #648733

    IATE #3543805
    Príomhimscrúdaitheoir Tagairt "Rialachán (AE) Uimh. 536/2014 an 16 Aibreán 2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, 32014R0536.http://eur-lex.europa.eu/legal-content/EN-GA/TXT/?uri=CELEX:32014R0536&FROM=GA"
    ga
    Comhthéacs Ní fhéadfar modhnú substaintiúil, lena n-áirítear láthair trialach cliniciúla a chur leis nó príomhimscrúdaitheoir ar láthair trialach cliniciúla a athrú, a chur chun feidhme ach amháin má tá sé formheasta i gcomhréir leis an nós imeachta a leagtar amach sa Chaibidil seo. Tagairt "Rialachán (AE) Uimh. 536/2014 an 16 Aibreán 2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, 32014R0536.http://eur-lex.europa.eu/legal-content/EN-GA/TXT/?uri=CELEX:32014R0536&FROM=GA"
    PI Tagairt ---
    ga
    Sainmhíniú Ciallaíonn “príomhimscrúdaitheoir” imscrúdaitheoir arb é an ceannaire freagrach é ar fhoireann imscrúdaitheoirí a dhéanann triail chliniciúil a stiúradh ag láithreán trialach cliniciúla. Tagairt "Rialachán (AE) Uimh. 536/2014 an 16 Aibreán 2014 maidir le trialacha cliniciúla ar tháirgí íocshláinte lena n-úsáid ag an duine, agus lena n-aisghairtear Treoir 2001/20/CE, 32014R0536.http://eur-lex.europa.eu/legal-content/EN-GA/TXT/?uri=CELEX:32014R0536&FROM=GA"
    Projektleiter | wissenschaftlicher Projektleiter | Hauptprüfer
    de
    Sainmhíniú hauptverantwortlicher Wissenschaftler eines Forschungsprojekts Tagairt "EP-DE, basierend auf: FWF Der Wissenschaftsfonds: FWF-Richtlinie – Überblick, https://www.tuwien.ac.at/fileadmin/t/quaest/doc/FWF-Richtlinie_UEberblick.pdf (15.6.2016)"
    principal investigator
    en
    Sainmhíniú "investigator who is the responsible leader of a team of investigators who conduct a clinical trial at a clinical trial site" Tagairt "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"
    investigateur principal | chercheur principal | CP
    fr
    Sainmhíniú personne qui est chargée de mener et de coordonner un essai clinique ou une étude scientifique, au sein d'un organisme de recherche Tagairt "Conseil-FR, d'après: - Site de la Fondation belge contre le cancer, Lexique > «Chercheur principal» (9.2.2022)- Recommandation (UE) 2021/1700 relative aux programmes internes de conformité pour les contrôles de la recherche portant sur les biens à double usage en vertu du règlement (UE) 2021/821 instituant un régime de l’Union de contrôle des exportations, du courtage, de l’assistance technique, du transit et des transferts en ce qui concerne les biens à double usage"