Composition of the data monitoring committee, its role, and reporting structure {21a}
DMSB
Safety oversight will be under the direction of the DSMB which is composed of individuals with expertise in pediatric emergency medicine, pediatric intensive care, pediatric nephrology, and biostatistics. Members of the DSMB are independent from study conduct and free of conflict of interest. The DMSB is operating under the rules of an approved charter that was approved at the initial DSMB meeting. Each data element that the DSMB requires to perform its duties has been clearly defined and these will be provided to them by the EDC. The DSMB has provided its input to the study PIs, sponsor, and other regulatory agencies, as appropriate. The funder, represented by an NIAID program officer and medical monitor will be invited to attend open sessions of the DSMB meetings as a consultative non-voting member, and they will receive copies of the minutes and the charter.