Prices

The GCP unit is financed by a basic funding grant from the Central Denmark Region and Aarhus University together with the North Denmark Region and Aalborg University. The GCP unit therefore provides free monitoring and GCP assistance of up to 100 hours for research-initiated clinical trials and trials of medical devices which are carried out under these institutions. For assistance in addition to the above-mentioned hours, a fee of DKK 700 per hour is charged.

The price is determined on the condition that the trial can be characterised as a non-commercial trial, which according to the GCP units is conditional on:

  • there not being existing agreements on the use of trial data for a pharmaceutical company's marketing or regulatory purposes.
  • the design, performance, data registration and reporting of the trial must be under the control of the sponsor.
  • the trial may not be part of a company's development plan for a medicinal product.

Clinical trials conducted outside of the above institutions, trials that do not have a duty of notification to the Danish Medicines Agency, as well as trials that are not considered to be research-driven, will be charged for the GCP unit's services.