Central monitoring
EVENTS
Central/remote monitoring will incorporate a variety of methods to detect and resolve potential data quality issues. Within the EDC, preprogrammed data edit checks (e.g., out-of-range values, required fields, skip patterns) will trigger queries to hospitals in real time (e.g., upon data entry). The NRN DCC will also manually review the data monthly, which may result in the data manager manually entering queries in the EDC that site study staff must complete. Email communications with the site will be used to resolve more complex questions about the data.The NRN DCC will generate study-level and hospital-level status reports that will be updated and reviewed on a monthly basis. These reports will identify issues such as missing forms, major protocol violations, or safety events that require follow-up. The trial subcommittee will then discuss these study-level and hospital-level status reports on monthly subcommittee calls to identify overall study and hospital trends that suggest deviations from the specified protocol procedures, data quality concerns, or occurrence of safety events of concern. Sites identified with concerning trends will meet with selected members of the trial subcommittee to discuss the errors and potential solutions. Following the conference call, if the site is identified again with concerning trends, the sponsor will meet with the site and remediation plan will be requested.