CAAmendment object
Authorisation mandatory for
Substantial amendments relating to a specific document that has been exclusively evaluated by either CA or EC: only submission to respective institution required
Responsible for submission of SA
Sponsor
Standard notification form available
Yes
Standard notification form
The standard application form to be used for the submission of substantial amendments is provided on the AEMPS website in section “Aclaraciones sobre la aplicación de la normativa de ensayos clínicos”: Anexo 1C.
The application must be in writing, dated and signed by the sponsor and investigator.
Timeline for approval of SA (max nr days)
35
From date of notification of receipt
By silent (implicit) approval
