Australia

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.

Clinical Trial Application	Spain Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	Minimum 2.500.000 €/protocol per year 250.000 €/patient
Tail Coverage	2 years
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Spanish • Site List in Spanish, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s) Foundation/Site Location(s) Address(es) with Area Code • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in the Protocol