SSInsurance object
Investigator(s)
Sponsor
Study participants
Sponsor
1) Pharmaceutical Injuries Insurance:
For clinical trials with medicinal products in Finland, the study sponsor’s responsibility is to confirm the validity of the study subjects’ insurance to cover all pharmaceutical injuries related to the investigational medicinal product. This may be either the Pharmaceutical Injuries Insurance, or other equivalent Insurance.
Pharmaceutical injuries insurance or other equivalent insurance must cover any bodily injury (pharmaceutical injury) of study subjects during the clinical trial resulting from the investigational drug or pharmaceuticals used as comparators in the trial if the specified criteria are met.
(2) Patient Injuries Insurance:
In Finland, all health and medical care providers must be covered by Patient Injuries Insurance against liability arising as provided under the Patient Injury Act No. 585/1986. All legally operating health care units in Finland (i.e. hospitals, public health centers and private health care clinics) are obliged to have the insurance for all employees working with patients, and for a valid insurance cover all employees must have valid and signed employment contracts with the unit or hospital where they (i.e. study personnel) are working.
For more information please see Finnish Patient Insurance Centre.
