The aim of inspecting clinical trials is to ensure that the trials meet the standards for good clinical practice (GCP). This includes attention to trial subject well being, safety and rights as well as good data quality.
The Danish Health and Medicines Authority has statutory authority to control any company etc. that carries out or has carried out clinical trials of medicinal products in Denmark (cf. section 90(2) of the Danish Medicines Act, no. 1180 of 12 December 2005).
We inspect clinical trials both in Denmark and abroad. This includes inspections coordinated by the European Medicines Agency (EMA). EMA inspections follow European procedures.
Apart from inspections of individual trials, we also perform system inspections covering several trials, where the inspection particularly focuses on e.g. monitoring, handling of adverse reaction reporting, etc.
We make a risk-based assessment to select which clinical trials to inspect.
Via the factbox to the right, you can find further information about guidelines for good clinical practice and GCP inspections.
Inspection reports in the national program
Once we have completed a GCP inspection, we draw up an inspection report for the inspected parties and the entity responsible for the clinical trial (sponsor) or the sponsor's representative. The inspected parties can be one or more of the following: investigator, sponsor, contract research organisation (CRO), manufacturer, hospital pharmacy and laboratory.
One inspection report is prepared for each GCP inspection to be given 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 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 authorisation or accept from the Danish Health and Medicines Authority.
Inspection reports classify deviations as 'critical', 'major' or 'minor' with reference to the classification used in inspections performed for the EMA (read more on classification via the link in the box to the right).
Deviations are classified depending on the concrete circumstances of each individual inspection and they are evaluated relative to the deviation's risk to trial subject safety and integrity 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 Health and Medicines Authority adds the inspection findings to the European Clinical Trials Database, EudraCT.