Recommandations européennes pour la constitution et la soumission des dossiers de recherche clinique portant sur les médicaments.
Clinical trials - Notice to applicants., EUDRALEX, Volume 10 - Clinical trials.
European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals, 20/07/06.
Detailed guidance on the application format and
documentation to be submitted in an application
for an Ethics Committee opinion on the clinical
trial on medicinal products for human use.
European Commission - Enterprise and Industry Directorate General , octobre 2005.
Detailed guidance on the collection, verification
and presentation of adverse reaction reports
arising from clinical trials on medicinal products
for human use.
European Commission - Enterprise and Industry Directorate General , avril 2006.
Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. , April 2004.