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Frequently Asked Questions

How often should I attend GCP training?

There are no requirements in the regulations to how often you should complete a GCP training or refresh your GCP knowledge. Our recommendation is that this is done on a regular basis and that you at least should have completed a training after 2016, when the ICH-GCP last was revised. It is important that you as research personnel are aware of these revisions. Your section / department / division may have other requirements. 

How do I make a code list in MedInsight?

Medinsight has its own IT-solution for registering code lists. This is the only approved OUS solution for storing code lists in clinical research, see eHåndboken. You can make new code lists in the solution, or upload existing code lists from Excel, to be stored safely in the solution. This solution is free of charge. For more information, click here.

If you are going to make a code list in MedInsight for the first time, please send an e-mail to oushfpbmedinsight@ous-hf.no and ask for user credentials.

How do I get in touch with named persons in the CTU?

You will find contact information for all employees on our department page (in Norwegian) at Oslo University Hospital's website.

Should there be a logo on the informed consent form and if so which one?

REK (the Regional Ethics Committees) has in some cases requested a logo to be entered at the informed consent form.

If a logo is to be used, it should be the logo of the hospital at which the patient is recruited. In a multicenter trial, this means that hospital-specific versions with a logo for each individual participating hospital must be created.

If a separate logo has been prepared for the study, this can be used with or without a hospital logo.