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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Clinical trials involving humans must be authorised by the Medicines Agency on the basis of an application submitted by the individual, company or group that takes overall responsibility for the trial (ie, the sponsor). A doctor or dentist must always participate in the conduct of the trial. The agency evaluates both the quality of the investigation and patient safety issues.
In addition, clinical trials must be authorised by the competent regional research ethics committee, which performs an overall assessment of the trial’s ethical aspects.
Both approvals must be obtained before the initiation of the trial.
How robust are the standard good clinical practices followed in your jurisdiction?
The Medicines Act expressly provides that all clinical trials must comply with good clinical practices. Detailed regulation of good clinical practice is also provided in secondary legislation, including Executive Order 695 (June 12 2013) on good clinical practice in clinical trials of medicinal products for humans.
The Medicines Agency performs inspections of clinical trials to ensure full compliance with the standards of good clinical practices. The agency inspects clinical trials both in Denmark and abroad. Deviation from good clinical practice is rarely seen in Denmark.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The sponsor is required to notify the Medicines Agency of the completion of the clinical trial no later than 90 days after completion. In addition, on completion of the clinical trial the sponsor is required to disclose the clinical trial results to the agency as soon as possible and no later than one year after completion.
What are the informed consent obligations with respect to clinical trial subjects?
All patients participating in a clinical trial must receive both written and verbal information about the trial, and participants must give their informed consent before the trial begins. The legislation includes provisions on consent from participants who are not of age or legal capacity.
What are the insurance requirements for clinical trials?
It is the responsibility of the sponsor to ensure that adequate insurance schemes are in place.
What data protection issues should be considered when conducting clinical trials?
The Act on Processing of Personal Data (Act 429, May 31 2000, as amended) generally applies to the processing of personal data relating to an identified or identifiable person when the processing is conducted for medical or scientific purposes.
The act implements EU Directive 95/46/EC on data protection and is supervised by the Data Protection Agency.
However, pursuant to the Medicines Act and Executive Order 410 (May 9 2012) clinical trials of medicinal products need not be notified to or authorised by the Data Protection Agency.
The exemption does not apply to processing sensitive personal data in connection with non-interventional trials, research and statistics projects or biological material for future use if the biological material is expected to be used in trials of medical products or in the testing of medical devices.
Pharmaceutical companies conducting ongoing non-interventional trials, or other research subject to the notification requirement, can file a general notification and obtain authorisation from the Data Protection Agency to process sensitive data. It is also possible to file a general notification of the processing of biological material for future research.
Notwithstanding that notification is not required, the Act on Processing of Personal Data and any other relevant legislation must still be complied with. Accordingly, clinical trials are subject to the rules of the act and the data subject’s rights.
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