ARVO Annual Meeting, May 2012
This research focuses on improving the accuracy associated with estimating the number of medical history (MedHx), concomitant medications (ConMeds), and adverse events (AEs) terms and related discrepancies for dry eye and ocular allergy type ophthalmic studies. Improving the accuracy of these estimates, in turn, improves the accuracy of related resource planning and budgeting for these type studies. This research also addresses the reasons for screen failures (SFs). Resources to be considered include those affecting investigator sites, clinical monitoring, and clinical data management for activities such as data collection and entry into source documents, case report forms (CRFs), and resolution of related discrepancies.