Basics of Quality Management in CT

4. Monitoring

Unlike audits, monitoring is part of the routine control of the trial process and is always carried out for all trials. It is a QC activity and as such is not intended to oversee systems but simply to control that a trial is being performed according to how it has been planned, described and approved.

Definition of monitoring in the GCP-guideline

‘The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).’

Monitoring is carried out by a monitor, who must be trained in the trial protocol and GCP-guideline. They must not be taking part in conducting the study. According to the GCP-guideline monitoring should normally be performed before, during and after the trial. This is normally practised as follows.