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Définition IMP / NIMP

Guidance européenne

  • Soumission projets cliniques
    • ECAF - Request for Opinion from the Ethics Commission - 2012
    • CE - Fiche signalétique du projet
    • DACE - Formulaire de demande d'avis au Comité d'Ethique - 2017
    • DACE - Etude rétrospective - 2017
    • DACE - Etude sur MCH - 2017
    • DACE - déclaration de COI - 2017
    • Protocol redaction plan
    • CE - Formulaire de demande d'assurance
    • CE - Classification des risques - études
    • Request for invoice
    • EU Guidance for EC's sumission file
    • EU Guidance - Request to the competent authority
    • Request for authorisation of a substantial amendment
    • Définition IMP / NIMP
    • Algoryhhme de distinction IMP / NIMP
  • Suivi projets cliniques
    • SAE-SAR-SUSAR form
    • EU Guidance - Adverse event notification.
    • Rapport annuel et rapport de fin d'étude
    • Declaration of the end of a clinical trial
    • Déclaration de non compliance et de problème imprévu
    • Formulaire de plainte liée à un projet clinique
  • Aspects légaux & recherche clinique
  • Divers
File
draft_guidance_definition_imp_2006_07_27_2.pdf

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