(a) Centralised monitoring is an evaluation of accumulated data, performed in a timely manner, by the sponsor’s qualified and trained persons (e.g., medical monitor, data scientist/data manager, biostatistician).
(b) Centralised monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of site monitoring or be used on its own. Use of centralised data analytics can help identify systemic or site-specific issues, including protocol noncompliance and potentially unreliable data.
(c) Centralised monitoring may support the selection of sites and/or processes for targeted site monitoring.