Do you have an IIT study, with DSMC as the only monitoring entity?
Did you know that the DSMC only reviews adverse events and deviations entered in OnCore?
So if they are not there, they cannot be reviewed!!
Make sure you’re contemporaneously entering all of your study’s adverse events and deviations in a timely manner for their review. The DSMC reviews the OnCore reports monthly looking for safety and quality of the clinical trials. If it’s not entered, they can’t review your trial for data and subject safety!