Table 1.

Electronic Data Capture (EDC) and serious adverse event (SAE) reporting

	Sites	Total participants randomised	Mean participants randomised per site	Median number of queries opened per participant	Median number of missing values per participant	Median number of missed visits per region	Median days from actual visit to EDC initiation	Median days from EDC entry to completion	SAEs reported per 10 participants	Median days from SAE occurrence to initial SAE report	Median days from initial SAE report to final, accepted SAE report
Asia	5	101	20	25	22	0	3	9	2	8	37
Australia	10	33	3	35	26	1	5.6	14	2	24	7
Europe	7	64	9	37	53	1	8.7	11	2	5	67
Latin America	11	121	11	34	15	1	5.7	17	1	4	8
North America	3	10	3	21	26	1	13.2	9	0	0	0