Germany

Clinical Trial Application	Germany Clinical Trial Quote Request Germany Business Travel Accident Application (OPTIONAL) Clinical Trials Quote Request Go to Form
Mandated Coverage	Yes - Local Policy Required
Standard Limits	500.000 €/patient is typically mandatory 5 to 50.000.000 €/protocol (varies and is dependent upon review by the carrier and often driven at the request of the Ethics Committee)
Tail Coverage	5 years for the damage 10 years for the claim
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in German • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol - When the trial is completed, both the number of treated and the number of screened patients are required by the carrier and this may result in additional premium If you need to obtain a Germany Business Travel Accident policy, please note the process is VERY slow to obtain the certificate and policies so please allow plenty of time. In addition to the completed Travel Accident application, please provide the number of trips each subject will make.

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.