9.3 Study administration/committees 9.3.1 Executive committee (EXC) The EXC has the overall scientific responsibility of the study. Its tasks and responsibilities are to create and approve the final protocol, co-author protocol amendments whenever necessary, ensure a scientifically sound and safe conduct of the study, including by abiding to DSMB recommendations, decide on the DSMB recommendations, review and approve the statistical analysis plan, guarantee the integrity of data collection and analyses and to decide on the publication- and presentation policy of the final results and ancillary studies 9.3.2 Study management and coordination committee (SMCC) The SMCC has the overall clinical responsibility of the study. Its tasks and responsibilities are to review the protocol, review the CRF, support the EXC by advice, monitor progress of study enrollment, address/resolve study management problems and participate in the analysis and presentation of the results.