Prior to approval of the trial

At this stage the trial is planned and various documents have to be drawn up. The GCP and legal requirements that exist are described. 

In the menu to the left, you can read more and find links to relevant legislation and other requirements, as well as get information when preparing the documents. 

 

Contact to the GCP units

The GCP units would like to be involved in the trial at the earliest stage, preferably when the protocol is being developed.

Upon request to a GCP unit, a GCP coordinator/monitor will be appointed. The GCP coordinator/monitor will be responsible for guidance and monitoring. 

In collaboration with the researcher, an agreement and a monitoring plan are prepared. 

An estimated price is made for the monitoring of the trial.

Contact the GCP units