Presentation (CTI)

OBJECTIVES: To evaluate how eCOA monitoring signals can identify emerging risks of systematic missingness and trigger targeted interventions to preserve PRO data quality and interpretability.
METHODS: Cross-study monitoring data were reviewed to identify recurring signals associated with reduced compliance, including delayed training, incomplete setup, workflow misalignment, and missing or discordant records across systems. These findings were interpreted with stakeholder-informed insights to assess how monitoring outputs function within study execution.
RESULTS: Across studies, monitoring signals consistently identified recurring patterns of compliance risk, indicating where systematic data issues were likely to emerge. Late or missing training and incomplete setup were associated with increased likelihood of reduced compliance. These signals functioned as early indicators of downstream data risk rather than retrospective performance measures. Study teams used monitoring outputs to identify missed activities, flag sites for follow-up, reinforce workflows, and clarify responsibilities, demonstrating that signals can be translated into defined intervention actions. When intervention pathways were not clearly defined, signals remained informational rather than actionable. Under these conditions, sites continued to struggle when responsibilities were diffuse, manual steps were easy to overlook, or guidance was too fragmented to support timely correction.
CONCLUSIONS: Monitoring that identifies non-compliance without enabling timely response is insufficient to prevent systematic missingness or protect PRO data interpretability. Monitoring must be operationalized as a trigger for targeted intervention, including workflow reinforcement, reminders, accountability clarification, and focused follow-up. This reframes monitoring from retrospective oversight to an active control mechanism within study execution; when signals are linked to defined intervention pathways, they prevent avoidable data quality risks and support more reliable outcome interpretation.