SSInsurance object
Liability insurance or alternative arrangements for damages mandatory for
Study participants
Responsible for covering insurance
Sponsor
Applicable national legal framework/ Reference
Patient Injury Act SFS 1996:799 (Chapter 3 (13) LVFS 2003:6)
Additional Information
The study participants are covered by the above mentioned Patient Insurance LÖF via each County Council and/or the medicinal product insurance (“Pharmaceutical Insurance”).
The Pharmaceutical insurance is voluntary and owned by membership to the Swedish Pharmaceutical Insurance Association (Läkemedelsförsäkringen). The insurance covers almost all clinical trials performed by the vast majority of companies operating in Sweden. Sponsors who are employed by universities need to ensure that they are covered by insurance. The professionals involved in clinical trials are covered by the public professional insurance.
