Amendments are changes to the study protocol (and any other applicable study-related documents). They can be substantial or not substantial.
– Substantial amendments must be submitted to the involved Ethic Commettees (ECs) and Competent Authorities (CAs), if applicable.The Sponsor must receive written approval from the ECs/CAs before being implemented.
– Non-substantial amendments must be only notified to the ECs. The Sponsors does not need to receive a written approval before amendment implementation (some ECs can send to the Sponsor an acknowledgement of receipt).