Notified DSMC (Deviations Tab)
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Notified DSMC | If immediately (Reportable Event submission) reportable to IRB, enter date Reportable Event submission is sent to DSMC/DMC/DSMB. If the deviation does not require immediate (Reportable Event submission) IRB reporting, leave blank. |
Not Required | No |