Spain

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

Clinical Trial Application	Netherlands Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. www.ccmo.nl/en/insurance
Standard Limits	450.000 €/patient 3.500.000 €/protocol Effective July 1, 2015, new limits required are: 650.000 €/patient 5.000.000 €/protocol
Tail Coverage	4 years from the end of patient treatment
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Dutch - There are TWO insurance requirements. - Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO - The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy - Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate