ECAmendment object
Ethical review mandatory for
SA relating to aspects and documents that have been assessed by concerned EC(s)
Standard notification form available
Yes
Standard notification form
There is no standard form, unlike CT with IMPs. Only required information and documents have to be sent.
The application must be in writing, dated and signed by the sponsor and investigator.
Timeline Ethical review of SA (max nr days)
35
Applicable national legal framework/ Reference
Royal Decree 1090/2015 (Article 22)
Art 25 Circular 7/2004
Additional Information
Formal validation of application dossier: The EC has 10 days to validate the application of the substantial amendment.
A reasonable opinion is communicated to the sponsor and the national CA within the given timeline.
