Inspection of clinical trials (GCP inspection)
The purpose of inspecting clinical trials is to ensure that the trials meet the standards of Good Clinical Practice (GCP). This includes attention to the safety and integrity of trial subjects as well as good data quality.
The Danish Medicines Agency has statutory authority to control any company etc. that conducts or has conducted clinical trials of medicinal products in Denmark (see section 90(2) of the Danish Medicines Act, no. 1180 of 12 December 2005).
We inspect clinical trials both in Denmark and abroad, including inspections coordinated by the European Medicines Agency (EMA).
Apart from inspections of individual trials, we also perform system inspections covering several trials, where the inspection has particular focus on monitoring, handling of adverse reaction reporting, etc.
We make a risk-based assessment to select which clinical trials to inspect.
The GCP executive order: Danish executive order no. 695 of 12 June 2013 on good clinical practice in clinical trials of medicinal products in humans (in Danish).
See the External links box for more information about guidelines for good clinical practice and GCP inspections.
Once we have completed a GCP inspection, we make an inspection report for the inspected parties and the entity responsible for the clinical trial (sponsor) or the sponsor’s representative. The inspected parties may be one or more of the following: investigator, sponsor, contract acceptor (CRO), manufacturer, hospital pharmacy and laboratory.
We make one inspection report for each GCP inspection and hand it over to the inspected parties. We always send the report to the sponsor or the sponsor’s representative.
The content of the report depends on the inspected site and the background for and scope of the inspection. The report includes data on the time and place of the inspection, inspection participants, a description of observations and a list of deviations from current legislation, guidelines, trial protocol and own procedures.
Inspections are carried out as spot checks within one or more areas of the trial. Conditions, procedures or processes not specifically described in the report should not be considered an indirect approval or acceptance from the Danish Medicines Agency.
Inspection reports classify deviations as ’critical’, ’major’ or ’minor’ according to the classification used in inspections performed for the EMA (see the External links box for more information about classification).
Deviations are classified depending on the specific circumstances of each individual inspection and they are evaluated relative to the deviation’s risk to the safety and integrity of trial subjects as well as data quality. This means that seemingly similar deviations may be classified differently in two different inspections.
The immediate assessment of the gravity of the deviations is reflected in the report’s conclusion and the subsequent correspondence in connection with any additional justifications.
The Danish Medicines Agency adds the inspection findings to the European Clinical Trials Database, EudraCT.
Questions and answers on clinical trials
See our questions and answers on clinical trials, including inspections.