ECAmendment object
Ethical review mandatory for
Any substantial amendments affecting the safety of participants, changing the interpretation of the scientific pieces, etc
Responsible for notification of SA
Sponsor
Standard notification form available
No
Timeline Ethical review of SA (max nr days)
35
Guidance on submission of SA
Notification Format: in paper + electronically
14 copies of a summary of the amendments made + 14 copies of new full version + electronic version (CD-Rom or USB key)
Further guidance and examples of substantial versus non- substantial amendments are provided on the CNER website in section Procedures > Submission of a substantial amendment
