ECAmendment object
Ethical review mandatory for
Any substantial amendments to the study protocol
Responsible for notification of SA
Principal Investigator
Investigator
Standard notification form
Standard amendment notification form to be used.
Format: electronically (using digital signature)
Timeline Ethical review of SA (max nr days)
35
From date of receipt of valid application
Guidance on submission of SA available
Yes
Guidance on submission of SA
Further details on the notification of amendments and the characterisation of substantial amendments are provided in Section 6.0 of the Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics.
