ECAmendment object
Ethical review mandatory for
Any substantial modifications having a significant impact on any aspect of research
Responsible for notification of SA
Sponsor
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)
35
Additional Information
EC notifies the CA on its decision.