Monitoring

Monitoring is a sponsor duty and can combine site visits with centralized, risk-based review of the data. Its extent is set in a monitoring plan.

act of overseeing the progress of a clinical investigation (3.8) to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, this document, and the applicable regulatory requirements Note 1 to entry: Centralized monitoring is a remote evaluation of accumulated data and compliance to provide additional monitoring capabilities that can complement or reduce the extent and frequency of on-site monitoring.

ISO 14155:2020, clause 3.35