Frequency and plans for auditing trial conduct {23}
The study investigators will submit an annual report to the study sponsor (National Institute of Nursing) including details of enrollment in the past year, progress on the study aims, and any barriers to completing the study. The study progress will be reviewed by NIH via the yearly progress report. The team will also submit a yearly report to the University of Utah Institutional Review Board (IRB). The team will internally audit the study records yearly throughout the trial period.