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Confirmation of Fraud at a Center Where Patient Diaries Were Ultimately Found to Have Been Completed by Site Staff

CASE STUDIES
By CluePoints

The subject of this case study is a phase III trial in vascular disease. Over 4,500 patients were randomized across 160 sites. The CRF included 480 variables for 32 domains. The CluePoints solution was deployed after the last patient last visit. The sponsor had a specific concern regarding a center suspected to have falsified patient questionnaires.