Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Important protocol amendments will be made by the Chief Investigator following consultation with the TMG and the TSC. All changes to the protocol will be reviewed and approved by the Swedish Ethical Review Authority prior to their implementation. Amendments will then be communicated to research staff and participants by the PI. The major protocol changes will be updated by the Chef Investigator in the clinicaltrials.gov and ISRCTN registry protocol registration within 14 days.