CAAmendment object

Authorisation mandatory for

Any substantial amendments to the study protocol

Responsible for submission of SA


Timeline for approval of SA (max nr days)

22 working days (without requesting EC opinion), ); 35 (if EC opinion required)

Applicable national legal framework/ Reference

Section 18 of Decree No 35/2005

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.