You apply electronically by completing a notification form via the following page: http://www.drvk.dk/anmeldelse (in Danish only).
In addition, you must submit the following material to the competent research ethics committee:
- The total project material as described in the guidelines about notification.
- Documentation of the identity of the sponsor and the investigator.
- Documentation of the investigator’s education and experience, including clinical experience and research experience. See What documents to submit?
The material listed above must be submitted to the e-mail address of the competent research ethics committee using digital signature. Find contact information for the regional research ethics committees (in Danish only).
Notification of a clinical trial of medicines can be done via the joint notification portal DKMAnet (only for registered users of DKMAnet). Further guidance about this is provided on the website of the Danish Medicines Agency.