Inspection of clinical trials (GCP inspection)
Inspection of clinical trials on medicinal products (GCP inspection)
In Denmark, the conduct of clinical trials on medicinal products is controlled by the Danish Medicines Agency, which also receives reports of serious breaches of clinical trials conducted under Regulation (EU) No 536/2014 (the Regulation).
Reference to the Regulation (EU) No 536/2014 will be made in the sections below.
The GCP inspectors may be contacted at Send an email
Emails in the mailbox are read and responded to as quickly as possible. We endeavour to respond to enquiries within 14 to 21 days; however, our response time may be longer for non-urgent enquiries.
Inspection by the Danish Medicines Agency
The primary purpose of clinical trial inspection is to ensure that trials are conducted in accordance with the authorisation granted, the trial protocol approved, applicable law and good clinical practice (GCP). GCP is a set of international, recognised ethical and scientific standards that are applied in the design, conduct and reporting of clinical trials of medicinal products in humans.
GCP compliance is to ensure that the rights, safety and well-being of trial participants are protected, and that the results of the clinical trial are reliable.
The Danish Medicines Agency has statutory authority* to inspect any company etc. that carries out or has carried out clinical trials of medicinal products in Denmark.
*EU Regulation No 536/2014 (section 52) (the Regulation) and section 19 of the Danish Act on Clinical Trials of Medicinal Products.
The Danish Medicines Agency inspects clinical trials of medicinal products both in Denmark and abroad. This includes inspections coordinated by the European Medicines Agency (EMA).
When the Danish Medicines Agency conducts national inspections, it follows its own procedures. These procedures describe how trials are selected for inspection, the notice, conduct and reporting of inspections and the follow-up on observed deviations.
When the Danish Medicines Agency conducts inspections on behalf of the EMA, it follows the procedures published by the EMA:
The main difference between national inspections and inspections conducted on behalf of the EMA is that EMA inspections are conducted as part of the application process for a marketing authorisation whereas this is typically not the case for national inspections.
Selection for inspection
The Danish Medicines Agency selects clinical trials for inspection based on a risk assessment. This risk assessment considers a series of different risks, e.g. risks inherent in the trial design, the risk of the investigational medicinal product itself, the knowledge of the sponsor, contractors and trial site, including previous inspection outcomes, etc.
Inspections could be routine inspections, but they may also be triggered by, for example, reported serious breaches, received or missing safety reports or other reports, and/or information received from others (e.g. other EU authorities or whistleblowers) as well as at the request of the Medical Research Ethics Committees (MREC).
A request for an inspection could also come from an authority in another EU/EEA member state or be submitted by the EMA on behalf of its committee responsible for human medicines (CHMP). In this case, the Danish Medicines Agency would usually conduct the inspection together with inspectors from other EU/EEA member states.
All clinical trials are regulated by the same legislation, and the Danish Medicines Agency does not distinguish between investigator-initiated/academic clinical trials (non-commercial) or company-initiated trials (commercial).
Notice of inspection
The Danish Medicines Agency will usually give 2 to 6 weeks’ notice of a planned inspection. Inspections could also happen unannounced or at very short notice depending on the cause and scope of the inspection. Notice of inspections is given in writing to the sponsor and sometimes will be agreed in advance with the trial site/investigator.
The letter of notification will detail the time and place of the inspection, planned areas for inspection and will include a preliminary inspection plan. The letter of notification includes a list of documentation and data that the Danish Medicines Agency is to receive. Rooms and other facilities are expected to be made available. This will be stated in the letter of notification.
Who do we inspect
The Danish Medicines Agency inspects single trials and performs system inspections covering multiple trials and in which the inspection could have a particular focus, e.g. monitoring, handling of adverse reaction reporting, or the like.
Those inspected could be anyone performing trial activities, e.g. investigator, sponsor, contractor, manufacturer, hospital pharmacy, laboratory or a supplier of computerised systems.
Inspections may be carried out before, during or after the conduct of a trial, including as part of the review of an application for a marketing authorisation or as part of the follow-up on a granted marketing authorisation.
Standard inspection course
An inspection usually takes place over three to five days, but may be of shorter duration. This is typically the case of first-in-human (FIH) trials. FIH trials are usually completed before trial start. They may also be of longer duration, e.g. in the case of inspections of major companies, trials or systems.
Normally, at least two inspectors will be present during the inspection, one is the lead inspector. Inspectors undergoing training will often participate. They may come from other EU authorities. Experts may also be asked to assist during an inspection if needed. They will be accompanied by an inspector and may also ask questions and access documents and data and provide input for inspection reports.
During an inspection, the inspectors will verify that the trial is conducted in compliance with the granted authorisation, the approved trial protocol, governing law and good clinical practice (GCP). Inspections are carried out as spot checks within one or more areas of the trial.
An inspection usually starts with an opening meeting. Here the purpose and legal basis of the inspection are presented, and the parties are introduced. During this meeting, the inspectors will also describe the methods, procedures and references for the inspection.
Inspections will usually comprise interviews, a review of rooms and facilities, and a review of data and documentation either on paper or electronic formats. The usual areas covered during an inspection are:
- Organisation and staff
- Quality control
- Agreements/contracts
- Trial documents
- Rooms and equipment
- Regulatory approvals
- Investigational medicinal products
- Randomisation/unblinding
- Monitoring
- Handling of adverse reactions, events, etc.
- Recording and reporting of data
- Recruitment and treatment of trial subjects
- Data handling
- Archiving, TMF
The inspection is completed by a closing meeting at which the inspectors go through their observations. These observations are preliminary and serve as the basis for the inspection report. Observations do not necessarily translate to deviations in the inspection report but may appear as comments in the report.
In exceptional circumstances, the inspection may be conducted in whole or in part via video conferencing or similar.
Inspection reports
Once the Danish Medicines Agency has completed a GCP inspection, it prepares an inspection report for the inspected parties and the entity responsible for the clinical trial (sponsor) or the sponsor’s representative.
GCP inspection reports will be prepared as one single report per inspection for the inspected parties.
The content of the report depends on the inspected site and the cause and scope of the inspection. It will detail the time and place of the inspection and participants. The report describes observations and summarises deviations from appliable law, guidelines, trial protocols and own procedures.
Conditions, procedures or processes not specifically addressed or mentioned in the report cannot be considered as the Danish Medicines Agency’s indirect authorisation or approval.
The deviations in inspection reports are classified as ’critical’, ’major’ or ’minor’ pursuant to the classification used in inspections performed for the EMA.
Deviations will be classified based on the specific circumstances during the individual inspection and will be evaluated relative to the risk the deviations pose to the safety and integrity of the trial subjects and the quality of the data. This means that apparently identical deviations may be classified differently from inspection to inspection. The immediate assessment of the gravity of the deviations is reflected in the report’s conclusion and any subsequent correspondence given in additional clarifications.
Inspection reports are subjected to quality control before publication by the Danish Medicines Agency.
The Danish Medicines Agency enters the inspection findings in the European Clinical Trials Database; For trials conducted under the Regulation, findings are entered in the Clinical Trials Information System (CTIS).
Inspection follow-up
The inspected party or parties will be requested to submit a plan for corrective action and preventive action (CAPA) regarding deviations classified as major or critical, including information about the likely cause of the deviation and timelines for implementation of these CAPAs. This plan should normally be submitted within 4 to 6 weeks, but it depends on the gravity of the deviations. The deadline for submission of the plan will be communicated by the Agency with the inspection report.
The inspectors then review the plan and assess if it can be accepted. If the plan is accepted, the inspection is closed, and follow-up can be verified at a future inspection. If the inspectors do not accept the plan, communication will continue until an acceptable plan is reached.
The Danish Medicines Agency can impose sanctions, e.g. in the form of fines, if a sponsor or investigator has not sufficiently complied with applicable law.
Change log:
August 16, 2025 - general update and translation, adaption to Regulation (EU) 536/2014