Data management
RTI
RTI International will provide the following:Collaborates in the development, implementation, and monitoring of Weaning protocol.Provides biostatistical leadership in statistical design aspects of Weaning protocol.Provides data management, including development of case report forms (CRFs) and appropriate data collection systems.Supervising data entry activities, including instructing and certifying data entry personnel in software and hardware usage, and quality assurance of data entry.Designs and maintains central randomization system.Manages the Data Safety and Monitoring Committee for the trial, including scheduling meetings, the DSMC charter and preparing interim monitoring reports for the DSMC.Oversees the receipt and reconciliation of safety data.Supervises NRN site quality assurance efforts, including conducting site visits and remote monitoring of data.Prepares and distributes monthly reports, detailing data received, data consistency, miss data and adherence to protocol.Disburses capitation payments to clinical centers on the basis of enrolled patients and other study-specific milestone triggers specified in the study protocols.Provides the logistical support necessary to run an efficient and productive network.Provides biostatistical leadership for collaborative analysis of study data and publication of results.Prepares public-use data files.