The act of overseeing the progress of a clinical trial and of ensuring that the clinical trial is conducted, recorded and reported in compliance with the protocol, Good Clinical Practice (GCP), regulatory requirements, and ethical guidelines and SOPs. It is usually carried out by Clinical Research Associates (CRAs) (also known as Clinical Trial Monitors) on behalf of the sponsor or Contract Research Organization (CRO).
Monitoring involves a broad range of activities including, but not limited to, communication with investigator and study sites, verification of the investigator’s and study site staff’s 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.