ICH GCP in French

 in FrenchHGiiiFr

Les Bonnes Pratiques Cliniques (BPC) de l'ICH sont une norme internationale reconnue pour la conception, la conduite, l'enregistrement et la notification des essais cliniques impliquant des participants humains. Les BPC de l'ICH visent à assurer la protection des droits, de la sécurité et du bien-être des participants aux essais cliniques, ainsi que la crédibilité des données des essais cliniques.

Les BPC de l'ICH sont divisées en plusieurs sections, chacune traitant d'un aspect spécifique de la conduite des essais cliniques. Les principales sections des BPC de l'ICH sont les suivantes :

  • Principes généraux
  • Responsabilités des investigateurs

  • Essais cliniques impliquant des participants particulièrement vulnérables
  • Éthique des essais cliniques
  • Conception des essais cliniques
  • Conduite des essais cliniques
  • Gestion des données des essais cliniques
  • Documentation des essais cliniques
  • Rapports sur les essais cliniques
  • Archivage des documents des essais cliniques

Les BPC de l'ICH sont un élément essentiel de la réglementation des essais cliniques dans le monde entier. La conformité aux BPC de l'ICH est requise pour la plupart des essais cliniques menés dans les pays membres de l'ICH.

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