South africa

Clinical Trial Application	South Africa Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	No, but may be required by EC
Standard Limits	Provided by US Master Product Liability policy
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English

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