Data Type | Frequency of review | ||
---|---|---|---|
Each occurrence | Q 6Â months | Annual | |
Participant accrual (adherence to inclusion/exclusion); drop-out rates; randomization | Â | X | Â |
Adverse event rates (injuries) | X | X | Â |
Participant complaints | Â | X | Â |
Compliance to interventions | Â | X | Â |
Protocol violations/noncompliance | X | X | Â |
Out of range data | Â | X | Â |
Risk-benefit ratio assessment | Â | Â | X |
Stopping rules report | Â | Â | X |