Canada

Clinical Trial Application	n/a
Mandated Coverage	No
Standard Limits	Provided by US Master Product Liability policy. (If your study is being conducted in Quebec, please check with your CRO to confirm coverage under the US Master Product Liability policy is acceptable)
Tail Coverage	n/a
Data Required to Quote	Please submit an email request to our certificate team requesting a certificate at: techcertrequest@newfront.com and CC your Newfront Team. Include the following in your email: o Include in your email the following: RE: Protocol #, Country o Attach the Protocol and Informed Consent Form (ICF) documents, if not already provided to Newfront o If your CRO is requiring a local policy in Canada, please submit a Clinical Trial Liability Quote request and provide the estimated patient split per province for tax calculations.

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