SSInsurance object

Investigator(s)
Sponsor
Study participants

(1) Section 20(7) of the Committee Act
(2) Danish Act on the Right to Complain and Receive Compensation (2009) and Danish Liability for Damages Act (2005): regulate the conditions for paying compensation

Insurance or other compensation arrangemens must be in place to cover any harm or injury of the study participant/ patient as well as the liability of the investigator and the sponsor.

Persons taking part in biomedical trials that do not form part of the diagnosis or treatment of their illness shall also be regarded as patients. The same shall apply to donors from whom tissue and other biological material are taken.

The website of the Patient Compensation Association deals with compensation claims for patients injured in connection to treatment by the Danish Health Service. It als covers drug injury cases, i.e. cases where patients are injured because of adverse reactions to the medicines they take

The system is supplemented by private compensation and reimbursement schemes.