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Table 1 Electronic Data Capture (EDC) and serious adverse event (SAE) reporting

From: Assessing site performance in the Altair study, a multinational clinical trial

  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