Composition of the data monitoring committee, its role and reporting structure {21a}
ADVERSE EVENTS
The independent DSMC will have overall responsibility for interim data monitoring and operate based on the Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) and NRN charter for the DSMC. The DSMC meets regularly to review the ongoing ACT NOW Weaning protocol with respect to ethical and safety standards. It monitors the safety of the clinical trials and advises the on continued study conduct. The DSMC provides recommendations to the Directors of NICHD and ECHO about starting, continuing, and stopping the ACT NOW Weaning clinical trial. All data distributed to the DSMC and deliberations of the DSMC are strictly confidential. Decisions to alter or halt studies are the responsibility of the Directors of NICHD and ECHO. The DSMC may recommend protocol modifications based on concerns for patient welfare or scientific integrity. The committee has confidential access to statistical data and adverse events that it may require for its deliberations. It reviews interim reports of patient accrual and outcome measures provided by the Data Coordinating Center.