Current Edition

Central Risk-based Monitoring Supports Reduced Cost and Higher Levels of Data Quality

Good Clinical Practice (GCP) focuses on data quality and integrity. Clinical trial sponsors must demonstrate strict oversight of studies to ensure proper conduct, safety of study subjects and accuracy and completeness of clinical data. Sheelagh Aird at PHASTAR explores how traditionally, oversight of a clinical study includes on-site data monitoring, performed by or on behalf of the sponsors, with monitors visiting each study site at defined intervals.