Composition of the data monitoring committee, its role, and reporting structure {21a}
The data and safety monitoring board include an independent statistician, a clinical expert in neonatology, and two representatives of preterm infant parent organisations. The role of the data and safety monitoring board is to monitor the progress of the trial and to ensure that the conduct of the trial is safe and ethically acceptable. The data and safety monitoring board reports to the sponsor/investigator who has full responsibility regarding any decision concerning the continuation or stopping of the trial.