Última actualización: 25/04/2003
Se pone en su conocimiento que las guías de desarrollo de la Directiva 2001/20/CE sobre ensayos clínicos que siguen están ya disponibles en la página web de la Comisión http://pharmacos.eudra.org/F2/pharmacos/docs.htm- 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.
- 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.
- Detailed guidance on the European clinical trials database (EUDRACT database).
- Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module)
- Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use