SSInsurance object
Liability insurance or alternative arrangements for damages mandatory for
Investigator(s)
Sponsor
Study participants
Applicable national legal framework/ Reference
Art 15 & 16 Law 21/2014 (pt)
General Liability Insurance Law, DL 72/2008 (pt): Art 137-148 provides the legal requirements of the insurance contract.
Further legislation:
The Norma Regulamentar n.º14/2008-R (de 27 de Novembro)
is a liability law for mandatory insurance
Additional Information
The insurance covers all cases of liability for property damage and injuries suffered by the patient during the study and the year following its completion (if the damage to health it is imputable to the trial).
