There is a need for some trials to be monitored by professional groups in order to ensure that they
are being implemented according to the approved protocol and SOPs. The monitors will randomly
select Case Report Forms, which they will check for completeness and consistency. They cross
check data on forms with what is in the electronic files. Sometimes such monitoring is un-
announced. Monitors are not part of the trial research team and their reports and recommendations
are studied by the trial funding organizations, which may react in a way that may affect trial
implementation.