Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
All modifications to study protocols, following approval with the local ethics board, will be documented as amendments in the ANZ clinical trial registry. All participants having previously signed consent forms prior to change in protocol will be notified by email including the detail of the change and its impact on them and offered an opportunity to review a new written consent. If the change will not impact the participants’ involvement in the study, a change in the statistical methods, or a reduction in the frequency of recording of SAEs, or a change in study personnel, as an example, would not impact the participants’ involvement in the trial and thus they will not be notified of these changes.