GCP consulting.
I offer guidance and advice to researchers who wish do a clinical trial. Including how to write a
protocol according to the GCP regulation, preparing a data collection form, resposibility and apply for
permission to the Medical Agency and regional ethics committees. I also provide guidance in use of
current guidelines/templates/tools/homepages that exist.
Price per houre 600 NOK ex.mva. In addition there may be travel expenses.

Monitoring/quality control
I offer on-site monitoring throughout the study period, from planning to completion. This means,
checking consent, that data collection form has been filled out correctly, and that adverse events has
been reported. I also check up on the storage of documents and study medication. A detailed plan for
what to review and a plan for visits is determined through a written agreement before start. I will also
estimate the cost.
Price per houre 600 NOK ex.mva. In addition there may be travel expenses .

Courses in GCP
I arrange courses for 3 to 5 hours. The course focuses on how the studies are to be carried out in
accordance with the guidelines. The GCP course meets regulatory requirements for knowledge of GCP
for those involved in clinical trials. A course certificate are issued.
Price from 2000 NOK ex.mva. In addition there may be travel expenses.