Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
EVENT
In the event that a substantial modification is made to the protocol by the investigator, it will be approved by the sponsor. Before its implementation, the latter must obtain a favorable opinion from the ethics committee and an authorization from the ANSM within the scope of their respective competencies. A new consent will be collected from the people already participating in the study, if necessary.