ECAmendment object

Ethical review mandatory for

Any substantial modifications having a significant impact on any aspect of research

Responsible for notification of SA


Standard notification form

The CA standard form 'Form of request for substantial modification' (Formulaire 3) can also be used for application to EC and is provided on the ANMS website in section: Formulaires et modèles à télécharger (Forms and Downloads)

Timeline Ethical review of SA (max nr days)


Applicable national legal framework/ Reference

Articles L1123-9 and R1123-35&36 CSP

Additional Information

EC notifies the CA on its decision.