Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
All changes to the protocol will require the agreement of the Trial Steering Committee (TSC). We will notify the sponsor of agreed amendments to decide if the amendment is substantial or not. The chief investigator or delegate will ensure all amendment notifications and associated documents are updated and submitted to the relevant parties (e.g. sites, investigators, REC, institutional review boards (IRB), trial participants, trial registries, journals, regulators). All participating sites affected will be notified of the amendment in writing. All documentation relating to the amendment will be filed in the Trial Master File (TMF) and ISF.