ECAmendment object
Ethical review mandatory for
Any substantial amendments to the study protocol
Responsible for notification of SA
Sponsor
Timeline Ethical review of SA (max nr days)
22 working days (without requesting EC opinion), ); 35 (if EC opinion required)
Additional Information
In the application, the sponsor must state the reasons for such modification, and if this modification may have an impact on the safety of participants, then a draft of the modified patient information and informed consent must also be attached.