For clinical drug trials and trials where the intention is to obtain CE-labelling of medical equipment, you are obliged to follow Norwegian regulations and the guidelines found in Good Clinical Practice (GCP). For other interventional trials, monitoring is optional. Many choose to follow GCP also when it is not mandatory, because it gives a good quality assurance of the trial and may even make publication easier.

Section for monitoring at Oslo University Hospital helps you to risk evaluate your project, and have made a form including most aspects of a clinical trial and its pitfalls. We guide you through the form, identifying possible risks in the trials and advise upon mitigations to reduce or remove the risk.

Overview of our employees can be found here.