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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Before the start of a clinical trial, approvals must be obtained from both the Danish Medicines Agency (DMA) and the competent regional research ethics committee.
The sponsor (ie, the person, company or institution which takes overall responsibility for the clinical trial) must apply to the DMA for authorisation to conduct the clinical trial. Under certain circumstances, the sponsor may delegate this task.
Before authorising the clinical trial, the DMA evaluates both the quality of the investigation and the patient safety of the clinical trial. The regional research ethics committee will perform an overall evaluation of the clinical trial’s ethical aspects.
How robust are the standard good clinical practices followed in your jurisdiction?
The standard good clinical practices are highly robust. The DMA has the legal right to control any natural person, company or institution that conducts clinical trials of medicinal products in Denmark. It regularly performs trial site inspections of clinical trials to ensure compliance with the standards of good clinical practice.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The sponsor must report to the DMA that the trial has been completed no later than 90 days after its completion. For multinational trials, the DMA must be informed when the trial is completed in Denmark.
The trial results must be entered into the European Clinical Trials Database (EudraCT) as soon as possible and no later than one year after the trial has ended. The data will be made publicly available on the clinical trials register.
Although the register does not publish Phase 1 trials, results of such trials must still be submitted to the DMA within a year of completion.
What are the informed consent obligations with respect to clinical trial subjects?
Patients participating in a clinical trial must receive both written and oral information about the trial. Before the trial starts, participants must provide their informed consent to participate.
Patients under 15 years’ old may participate in clinical trials only with the consent of their legal custodian. As for patients under guardianship, the legal guardian must consent to the patient’s participation in a clinical trial.
What are the insurance requirements for clinical trials?
The sponsor must ensure that there is adequate and appropriate insurance in place to cover its responsibility towards any participant suffering harm.
What data protection issues should be considered when conducting clinical trials?
In general, Danish data protection legislation applies to the processing of personal data in connection with conducting clinical trials. As of May 25 2018, Danish data protection legislation comprises the General Data Protection Regulation. Therefore, the applicable data protection rules (whether the Danish data protection legislation or, as of May 25 2018, the General Data Protection Regulation) must be complied with.
Under existing Danish data protection legislation and the forthcoming General Data Protection Regulation, clinical trials need not be notified to or authorised by the Danish Data Protection Agency. However, until the entry into force of the General Data Protection Regulation, the processing of personal data in connection with non-interventional trials, storage of biological material for future use (ie, biological material that is not part of the individual clinical trials but stored for future research purposes) and research and statistics projects must be notified to the Danish Data Protection Agency.
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