Poland

Clinical Trial Application	Poland Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	FOR DRUG STUDIES 2.000.000 € up to 50 patients 5.000.000 € more than 50 patients FOR MEDICAL DEVICE STUDIES 50.000 € for up to 10 patients 100.000 € for 11 to 25 patients 200.000 € for 26 to 50 patients 400.000 € for 52 to 100 patients 500.000 € for more than 100 patients FOR OTHER STUDIES Clinical trials which are not regulated by local law OPTION A 5.000.000 PLN/protocol 500.000 PLN/patient OPTION B 10.000.000 PLN/protocol 1.000.000 PLN/patient
Tail Coverage	10 years maximum after the event causing the injury 3 years after the patient is aware of his problem
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Polish Only a Policy is issued for Poland

Clinical Trial Application	Australia Clinical Trial Quote Request
Mandated Coverage	No, but is typically preferred by EC
Standard Limits	AUD 10M or AUD 20M depending on territory where study is taking place. PLEASE CONFIRM WITH YOUR CRO for limit required
Tail Coverage	12 months but 72 months in respect of Western Australia and/or Queensland.
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO or Institution name (Contact Person Name, Address, Telephone Number and E-Mail Address) • Local CRO GST (Goods and Services Tax) Number. ABN (Australian Business Number) is also sufficient If Sponsor has a local entity to be listed without the Local CRO on policy, a Goods & Services Tax (GST) will be required for the local sponsor entity. If none available, there is a tax implication. The same trial in New Zealand can be added to this policy for additional premium. Please check with your CRO beforehand to advise if a shared policy is acceptable.