ECAmendment object

Ethical review mandatory for

Any substantial amendments to the study protocol

Responsible for notification of SA

Principal Investigator

Standard notification form available


Standard notification form

Standard amendment notification form to be used.
Submission Format: electronically (using digital signature)

Timeline Ethical review of SA (max nr days)

From date of receipt of valid application

Guidance on submission of SA available


Guidance on submission of SA

Detailed guidance on the notification of amendments, the required format 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.

Applicable national legal framework/ Reference

Part 6, Section 27 of the Committee Act