CPTU carries out regular monitoring, both at the clinical sites and centrally on the database, to ensure that trials are being conducted according to the protocol and applicable regulatory requirements.
The monitoring plan is created before a trial starts and is tailored to the particular trial and, if necessary, the particular centre. CPTU creates the monitoring plan after carrying out a risk assessment for the trial, which considers risks at all levels - from the rights and safety of patients, to the reliability of the data and results.
Those areas that are at highest risk are monitored with greatest intensity. The process is continually assessed throughout the trial, and monitoring is adjusted accordingly.