12. november 2018

What other authorities must I apply to?

Notification of clinical trials of medicines

Health research projects involving clinical testing of medicines (and in some cases medical devices) must also be reported to the Danish Medicines Agency.

See questions and answers about the notification of clinical trials of medicines to the Danish Medicines Agency, Introduction to clinical investigations of medical devices, Guideline for applications for authorisation of clinical trials of medicinal products in humans, 30 June 2016 and Guideline for applications for authorisation of clinical trials of medicinal products in humans.

Register-based research without biological material

Register-based research projects not including biological material need not be notified to the research ethics committee system.

If you want to use information from patient records in research, you need persmission from the Danish Patient Safety Authority. You can read more about the procedure here (in Danish only).

If you need to use health data as part of your research, you can apply for register data in the health area through Foskerservice (Research Services) at the Danish Health Data Authority.

Please be aware that research involving the processing of personal data must be notified to, and in some cases approved by, the Danish Data Protection Agency.

Notification to the Danish Data Protection Agency

Public health research projects that process personal data must also be notified to the Danish Data Protection Agency. Private research projects that must be notified to the committee system are from 15 May 2012 exempted from the duty to notify the Danish Data Protection Agency. However, such projects must still comply with the Act on Processing of Personal Data.

Furthermore, the establishment of biobanks for future research purposes must always be notified to the Danish Data Protection Agency (in Danish only).

See the guidelines from the Danish Data Protection Agency (in Danish only) here: