Gaois

Similar terms:

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 »

3 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #550930

    IATE #1237287
    imscrúdaitheoir Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    klinischer Prüfer | 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
    clinical investigator | investigator | clinical trial investigator | clinical trial investigators | investigators
    en
    Definition individual responsible for the conduct of a clinical trial at a clinical trial site Reference Regulation (EU) No 536/2014 on clinical trials on medical products for human use, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536&from=EN (11.11.2019)
    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
  2. SOCIAL QUESTIONS|health|medical science

    #527383

    IATE #156803
    bróisiúr imscrúdaitheora Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Information für den Prüfer
    de
    Comment Term defined --
    IB | investigator's brochure
    en
    Definition 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 Reference 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
    Comment Term defined --
  3. EDUCATION AND COMMUNICATIONS|information and information processing · SCIENCE|natural and applied sciences|applied sciences · SOCIAL QUESTIONS|health|pharmaceutical industry

    #582204

    IATE #3543805
    Príomhimscrúdaitheoir Reference 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
    Context 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. Reference 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 Reference ---
    ga
    Definition Ciallaíonn “príomhimscrúdaitheoir” imscrúdaitheoir arb é an ceannaire freagrach é ar fhoireann imscrúdaitheoirí a dhéanann triail chliniciúil a stiúradh ag láithreán trialach cliniciúla. Reference 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
    wissenschaftlicher Projektleiter | Projektleiter | Hauptprüfer
    de
    Definition hauptverantwortlicher Wissenschaftler eines Forschungsprojekts Reference 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 | PI
    en
    Definition lead investigator of a study Reference UC San Diego> School of Medicine > Research > Altman Clinical and Translational Research Institute >Community > Clinical Research Glossary (19.8.2022)
    CP | investigateur principal | chercheur principal
    fr
    Definition personne qui est chargée de mener et de coordonner un essai clinique ou une étude scientifique, au sein d'un organisme de recherche Reference 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