P15-14. Assuring data quality of the phase III vaccine trial of ALVAC vaccine priming and AIDSVAX vaccine boosting in Thailand

Results The CDM process was prepared at the trial initiation. The systems were routinely validated; the data, IT and quality assurance staff were trained to complete their responsibilities effectively. The data collected in this study met CDM metrics in both quantity and quality. In this study, 16,402 healthy volunteers enrolled into the study for 3 years follow-up. Of the 1,148,839 case record forms (CRFs), there were 82,502 QCs composed of 21% missing data and 22% inconsistent values; time to QC resolved ranged from 7 to 11 days. There were 2,691 events of protocol deviation captured and all get resolved timely. Data coding was done for 27,714 AEs and 2,925 SAEs using MedDRA; the AE and SAE databases were reconciled prior to the study closure. Source document and CRFs were 100% verified; the accuracy assessment for efficacy and safety data was performed before declaration of clean databases for final analysis.