(a) Monitoring may be performed in relation to the clinical trial activities at the investigator sites (including their pharmacies and local laboratories, as appropriate). The frequency of monitoring activities should also be determined based on identified risks. Monitoring activities and their frequency should be modified as appropriate using knowledge gained.
(b) This monitoring activity may be performed on-site and/or remotely depending on the nature of the activity and its objectives.
(c) Monitoring may include remote and secure, direct read-only access to source records, other data acquisition tools and essential record retention systems.