The lack of monitor data does not cause any formal obstacles in adding a protocol to the trial, scheduling and conducting patients’ visits, setting price list and changing the trial status (e.g. closed, cancelled). 

The monitor’s data is only needed to make monitor visits and supervises the trial. 

Such actions taken by the monitor allow them to, for example, evaluate the course of the trial and consent to the entrance of the trial to the next phase.

Such consent is provided outside the Hyggio system.

 

Within the Hyggio system itself, there is no mechanism to block a change in trial status/phase unless the monitor approves it.