Results for 'Slaheddine Fattoum'

  1.  4
    Ethical and Procedural Issues for Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside the European Union: The Challenging Experience of the DEEP Project.Adriana Ceci, Giorgio Reggiardo, Bianca Tempesta, Slaheddine Fattoum, Lamis Ragab, George Papanikolaou, Hugo Devlieger, Donato Bonifazi, Mariagrazia Felisi & Viviana Giannuzzi - 2021 - BMC Medical Ethics 22 (1):1-11.
    BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial. This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon (...)
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