Composition of the data monitoring committee, its role and reporting structure {21a}
Data monitoring will be performed by an independent monitor who will monitor the progression of the study, check the presence of informed consent, review the presence of standard operating procedures (SOPs) and adherence to the study protocol, SOPs and the Medical Research Involving Human Subjects Act (WMO), and verify accuracy and completeness of the data. The monitor will brief any issues to the study team, who will address and resolve these issues and report back to the monitor.