The aim of monitoring is to ensure the participants’ rights, safety and well-being and the reliability of trial results as the trial progresses. Monitoring is one of the principal quality control activities.
Monitoring involves a broad range of activities including, but not limited to, communication with investigator sites, verification of the investigator and investigator site staff qualifications and site resources, training and review of trial documents and information using a range of approaches including source data review, source data verification, data analytics and visits to institutional facilities undertaking trial-related activities. Some of these monitoring activities (e.g., centralised monitoring) may be conducted by different methods and persons with different roles (e.g., data scientist).
However, monitoring should be performed by persons not involved in the clinical conduct of the trial at the site being monitored. The monitoring approach should consider the activities and services involved, including decentralised settings, and be included in the monitoring plan. Monitors and other trial staff should adhere to data protection and confidentiality requirements in accordance with applicable regulatory requirements, institution policy and established data security standards.
Monitoring may include site monitoring (performed on-site and/or remotely) and centralised monitoring, depending on the monitoring strategy and the design of the clinical trial.
The sponsor should determine the appropriate extent and nature of monitoring based on identified risks. Factors such as the objective, purpose, design, complexity, blinding, number of trial participants, investigational product, current knowledge of the safety profile and endpoints of the trial should be considered.