Table 2.

Comparison of the efficiency of routine on-site monitoring and hybrid monitoring model.

Issue category per monitoring visit	Routine on-site monitoring, mean (SD)	Hybrid monitoring model, mean (SD)	P value
Number of patients	9.10 (11.166)	13.80 (19.967)	.004
Time consumption (hours)	11.63 (8.969)	10.73 (8.883)	.13
Number of AEa and concomitant medications	43.51 (52.096)	46.99 (55.718)	.45
Time consumption for AE and concomitant medications (hours)	7.23 (7.384)	6.46 (6.436)	.56
Number of CRFb pages	145.48 (135.356)	158.59 (151.562)	.66
Time consumption for reviewing CRF pages (hours)	10.27 (11.465)	8.77 (6.484)	.91
Total monitoring time (hours)	28.61 (20.719)	24.650 (20.950)	.03
Total monitoring cost (CNY ¥; CNY ¥7.15=US $1)	408.80 (688.131)	220.06 (337.367)	<.001

^aAE: adverse events.

^bCRF: case report form.