Plans for communicating important protocol amendments to relevant parties {25}
Changes in the test conditions shall only be made after mutual agreement between the PIs and the sponsor. Any change to the procedure laid down in the trial protocol must be made in writing, stating the reasons for the change, and signed by all persons responsible for the trial. The changes are then considered to be part of the protocol. Where necessary (e.g. in the case of a change in the investigational medicinal product dosing scheme or other significant changes that indicate a direct impact on the safety of the trial subjects), the consent of the ethics committees and/or regulatory authorities responsible as well as the investigator to the protocol amendments shall be obtained, and the amendment shall be submitted to the regulatory authority.