Table 1 Electronic Data Capture (EDC) and serious adverse event (SAE) reporting
From: Assessing site performance in the Altair study, a multinational clinical trial
| Â | 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 |