Data Collection and Monitoring
BRAIN DEATH
The ICU and in-hospital donation and transplant coordination staff recorded data (eg, inclusion and exclusion criteria, baseline clinical variables, brain death diagnosis variables, clinical management variables, and family interview information) from both study groups at the time of enrollment; at 6, 12, and 24 hours after enrollment; and every 24 hours for 14 days or until transfer from the ICU to the operating room. The same staff transferred data from case report forms to an electronic data capture system (REDCap; Vanderbilt University). Central study personnel produced monthly reports of data completeness and accuracy for all sites based on site visits and central statistical data monitoring to assess data quality and data sources.