France

Clinical Trial Application	France Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	1.000.000 €/patient 6.000.000 €/protocol 10.000.000 €/year
Tail Coverage	10 years
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in French • Site List in English, inclusive of Full Name(s) of Principal Investigator(s), the Hospital(s)/Site Location(s) Address(es) with Area Code. This information is for the carrier files only. Will not be listed on the policy documents. • Local CRO or EU Representative details (Contact Person Name and Telephone Number). Will be referenced on the Policy declaration page and the Certificate • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol

Clinical Trial Application	Turkey Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	€200,000 per patient €2,000,000 per protocol
Tail Coverage	3 years increasing to 5 years for trials involving children and/or recombinant biologics/gene therapy, radiopharmaceutical IMPs
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Turkish • Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address) - Carrier sends signed policy documents directly to the CRO - no signatures from Sponsor required - Only a Policy is issued in Turkey