Prices

The GCP-unit is financed by a basic funding grant from the Central Denmark Region and Aarhus University. The GCP-unit therefore provides free monitoring and GCP-assistance of up to 100 hours for investigator-initiated clinical trials of medicinal products 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:

  • The trial design, execusion, data recording and reporting must be under the control of the sponsor.
  • The objective of the trial must noty include trial data used for marketing purposes in a private sector company, or for regulatory purposes.
  • The trial must not be part of a private sector company development plan for a product.

Clinical trials conducted outside of the above institutions, trials with no legal requirement for GCP-compliance, as well as trials that are not considered to be investigator-driven, will be charged for the GCP-unit's services.