Data quality monitoring and assurance
SECONDARY, RECRUITMENT
Strategies to improve or monitor adherence to the study protocol will include the following:Monthly recruitment reports of infants screened and enrolled (accrual figures)Monthly reports detailing data received at the NRN DCC, data consistency, missing data, performance measures, and adherence to the study protocol (with appropriate measures taken to preserve the blinding of study personnel and investigators)Supplementary blinded reports requested by the study investigators or subcommittee that do not disclose allocation group-specific outcomes (primary, secondary, or any safety outcomes).The DCC will generate the aforementioned reports.To assure the quality of the data collected, the trial investigators will conduct training sessions on protocol implementation, data acquisition, and data transfer. Sites will be required to attend a mandatory training session that engages multiple research team members, including at least one site investigator, one study coordinator, and one data entry staff. This training will consist of a walkthrough of the protocol, randomization procedures, study intervention, data collection procedures, the Manual of Operations (MOP), and demonstration of the electronic data capture system. The training will provide guidance specific to accuracy of data acquisition for the research coordinators at each site. The data collection forms will be piloted by a subset of sites to minimize the potential for errors. Additionally, in-depth pharmacy training will be held with site pharmacists that will consist of a walkthrough of the protocol, randomization procedures, study drug dispensing, blinding, and demonstration of the EDC. Sites will be required to attend both the protocol and pharmacy training prior to study launch. Sites will also be required to attend annual protocol refresher sessions until enrollment is complete.The NRN DCC will employ a mixed method data quality monitoring approach that will involve a combination of the following methods: centralized monitoring, chart re-abstraction, and onsite monitoring.