Table 4.

Factors influencing time to governance submission to governance approval (days) for 145 site activations

	Median (range)	Univariable p-value* Multivariable p-value**
Overall	34 (0, 489)
Phase
1 (n = 17)	39 (0, 89)	0.2*
2 (n = 27)	45 (1, 140)	0.014**
3 (n = 93)	33 (0, 489)
4 (n = 8)	18 (12, 99)
Disease area of trial
Nephrology (n = 49)	37 (0, 489)	0.012*
Oncology (n = 40)	17 (0, 112)	0.044**
Endocrinology (n = 24)	41 (3, 192)
Neurology (n = 22)	47 (1, 140)
Paediatrics (n = 10)	40 (21, 433)
Country
Australia (n = 126)	34 (0, 489)	0.094*
South Korea (n = 10)	10 (0, 102)	NA**
Hong Kong SAR (n = 5)	62 (9, 87)
Taiwan (n = 0)	-
New Zealand (n = 4)	30 (7, 56)
Trial site ownership
Government (n = 108)	35 (0, 489)	0.3*
Private (n = 18)	28 (3, 77)	0.032**
Unknown (n = 19)	14 (0, 102)
Scope guidelines used for the governance review
Yes (n = 110)	28 (0, 489)	< 0.001*
No (n = 35)	79 (3, 135)	0.020**
Triage by low, medium, or high risk
Yes (n = 111)	24 (0, 489)	< 0.001*
No (n = 31)	81 (29, 135)	0.043**
Unknown (n = 3)	10 (6, 53)
COVID-19 pandemic
Pre-pandemic (n = 109)	31 (0, 192)	0.12*
During or after pandemic (n = 36)	41 (7, 489)	0.013**

NA not applicable because only one country (Australia) had data to enable multivariable analyses

^*p-value from univariable comparison

^**p-value from multivariable comparison that included disease area; phase; trial site ownership status (N/A data removed from ownership status); the use of scope guidelines by the governance body; a governance approval process that triaged applications as low, medium, or high risk; and pre- or post-COVID in the regression model