Table 3.

Data review schedule

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