SOCIAL QUESTIONS|health|pharmaceutical industry
- dea-chleachtas cliniciúil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- Context 'Tabharfar tuairisc ar aon oiliúint a fuarthas roimhe sin i bprionsabail an dea-chleachtais chliniciúil nó ar aon taithí a fuarthas ó obair i mbun trialacha cliniciúla agus ar chúram othar.' 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
- GCP | good clinical practice
- en
- Definition set of detailed ethical and scientific quality requirements for designing, conducting, performing, monitoring, auditing, recording, analysing and reporting clinical trials ensuring that the rights, safety and well-being of subjects are protected, and that the data generated in the clinical trial are reliable and robust Reference Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
- Comment Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible.
- bonne pratique clinique | BPC | bonnes pratiques cliniques
- fr
- Definition ensemble de dispositions qui garantissent la qualité dans la conduite d'un essai, le recueil des résultats, les droits et la sécurité des personnes participantes, ainsi que la confidentialité des informations Reference Act Up-Paris,Gloss.sida,janvier 1998