SSInsurance object

Liability insurance or alternative arrangements for damages mandatory for

Investigator(s)
Sponsor
Study participants

Responsible for covering insurance

Sponsor
Investigator

Applicable national legal framework/ Reference

Art 3 (1f) of modified RGD 30 May 2005
Art 25 of Hospital Act of 28th August 1998 (fr)

Additional Information

Provisions for insurance or indemnity to cover the liability of the investigator and sponsor are mandatory.
According to Art 25 of Hospital Act of 28th August 1998 (fr) the sponsor / investigator shall subscribe an insurance covering his responsibility as well as the responsibility of all the persons involved.
The study insurance covers the risks encountered by the patients during their participation in the trial. In case of malpractice and non-conformity to the protocol, the insurance might of course turn against the physician. It is the responsibility of the physicians in Luxembourg to have a liability insurance and to check whether it covers malpractice or not.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395