Composition of the coordinating center and trial steering committee {5d}
NRN, Non-NRN, non-NRN
RTI
NIH Program Officers at NICHD and ISPCTN-ECHO (in the NIH the Office of the Director (OD)) will be responsible for:• Providing oversight for the trial.• Facilitating and participating in all study-related committees.• Funding the study, administering the Protocol Review Committee (PRC) which meets at a minimum twice a month.• Administering the Data Safety and Monitoring Committee (DSMC) which meets on a quarterly basis.• The NIH Program Officers at each of these institutions will have final authority on the commencement and continuation of the protocols.Three coordinating centers will collaborate to perform all coordination activities for the ACT NOW collaborative:ECHO Coordinating Center (CC) – Duke Clinical Research Institute (DCRI)NRN Data Coordinating Center (DCC) – RTI InternationalECHO ISPCTN Data Coordinating and Operations Center (DCOC) – University of Arkansas for Medical Sciences (UAMS)The three coordinating centers will be jointly responsible for working with the Clinical Sites on study implementation. Activities include training, data management and biostatistical management. Responsibilities for each organization are outlined in the subsections below.The CC, DCRI, will:Be responsible for the daily operations across all non-NRN sites (e.g., ISPCTN sites and other sites)Monitor the performance of all non-NRN clinical sites and meet with NICHD and NIH on a regular basis to review site performance.Administer site contracts with non-NRN sites.Pay site capitation to Non-NRN sites.The DCC, RTI International, will:Be responsible for the daily operations across all NRN and several non-NRN sites.Collaborate in the development, implementation, and monitoring of Weaning protocol.Provide data management, including development of Case Report Forms (CRFs) and appropriate data collection systemsSupervise data entry activities, including instructing and certifying data entry personnel in software and hardware usage, quality assurance of data entry, etc.Manage the Data Safety and Monitoring Committee (DSMC) for the trial. This will include scheduling meetings and the DSMC charter.Oversee the receipt and reconciliation of safety data.Supervise Neonatal Research Network (NRN)-site quality assurance efforts, including conducting site visits and remote monitoring of data.Prepare and distribute monthly reports, detailing data received, data consistency, missing data, and adherence to protocol.Disburse capitation payments to clinical centers on the basis of enrolled participants and other study-specific milestone triggers specified in the study protocol.Provide the logistical support necessary to run an efficient and productive network.The DCOC, UAMS, will:Act as the central IRB regulatory oversite for this protocol.