Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
A protocol amendment is defined as an amendment to the terms of the MREC application or to the protocol or any other supporting documentation that is likely to affect to a significant degree:The safety or physical or mental integrity of the subjects of the trial.The scientific value of the trial.The conduct or management of the trial.The quality or safety of any intervention used in the trial.Any protocol amendment will not be implemented prior to MREC approval and will be communicated with the trial participants and the trial registries.