The monitor is the principal communication link between the sponsor and the investigator and is appointed by the sponsor. The number of monitors needed to ensure adequate monitoring of the clinical trial will depend on its complexity and the types of centres involved.
The main responsibility of the monitor is to oversee progress of the trial and to ensure that the study is conducted and data are handled in accordance with the protocol, Good Clinical Practice, and applicable ethical and regulatory requirements. The monitor is responsible for controlling adherence to the protocol, ensuring that data are correctly and completely recorded and reported, and confirming that informed consent is being obtained and recorded for all subjects prior to their participation in the trial. Any unwarranted deviation from the protocol or any transgression of the principles embodied in Good Clinical Practice should be reported promptly to the sponsor and the relevant ethics committee(s).
The monitor should follow a predetermined written set of standard operating procedures (SOP). A written record should be kept of all visits, telephone calls and letters to the investigator.