Table 1.

Outcomes of IRB models used in CHAP trial.

	Shared IRB (N=7)	Individual IRB (N=38)	p-value
Time from initial submission to final approval, days	41 (7–165)	56 (0–183)	0.424†
Time from initial submission to final approval greater than 60 days: N (%)	2 (29%)	16 (42%)	0.684‡
Number of IRB submission rounds	1 (1–2)	2 (0–6)	0.087†
Number of stipulations from IRB prior to approval	1 (0–6)	4 (0–70)	0.122†
Total number of full IRB meetings prior to approval; N (%)  None  One  Two  Three	6 (86%) 1 (14%) 0 (0%) 0 (0%)	1 (3%) 25 (63%) 11 (29%) 1 (3%)	<0.001‡

^†Kruskal-Wallis Test

^‡Fisher’s Exact Test

All data are median (range) unless otherwise specified (Hub site=Individual IRB).