We are aware that COVID-19 has consequences with regards to the conduct of clinical trials in Denmark. Multiple factors play a role such as trial participants in quarantine, limited access to public places (including hospitals) due to the risk of spreading infections etc. We acknowledge that the consequences are likely to cause more protocol deviations than normal. NVK therefore recommends that the committee system will follow the recommendations contained in the Danish Medicines Agency's issued guideline: Extraordinary measures for clinical trials due to COVID-19 (updated 1 April 2020)
Changes to existing projects, as a consequence of COVID-19, which are in addition to those mentioned in the Danish Medicines Agency's guidance, must as usual be notified to the regional committee for the area in which the principal investigator is working. Changes to projects relating to particularly complex areas must also as usual be notified to the National Committee on Health Research Ethics (NVK).
Notification of new clinical trials related to COVID-19 must be made to the regional committee for the region in which the principal investigator is working. Projects relating to particularly complex areas must be notified to NVK.
NVK and the Regional Health Research Ethics Committees have positively committed to urgently process inquiries and trials related to COVID-19. The processing of the notified trials could take place on virtual meetings in the committees.
Please send an e-mail to email@example.com or the regional committee including "COVID-19" in the subject line. (Click to get contact information for the regional committees, in Danish)