Transfer of clinical trial data
Instead of the conventional approach of receiving data for pharmacometric analysis after the trial completion, an iterative data transfer and reproducible data handling workflow was developed by consensus between the clinical, data management, and pharmacometric teams who collaborated in this clinical trial. Data QC and review responsibilities were shared between the clinical, data management, and pharmacometric teams. Figure Overview of the data management throughout the clinical trial. Number of participants on trial over time is shown in purple solid line, database locks (n = 2) are shown in black dashed lines, scheduled data review (n = 41) are shown as magenta top rug plot, first reported diagnosed COVID-19 case in South Africa is shown as grey bottom axis mark for reference.