SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Study participants

Applicable national legal framework/ Reference

Art 5&6 Regulation no 433/2004

Additional Information

Subjects participating in a clinical trial of a medicinal product must be sufficiently insured against conceivable damage to their health resulting from the trial.
The principal investigator or, as the case may be, the investigator shall be responsible for ensuring satisfactory insurance coverage.
Insurance or compensation to cover the liability of the investigator and sponsor for compensation.