Ukraine

Clinical Trial Application	Ukraine Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	Limit per protocol = 10.000 USD x number of patients
Tail Coverage	3 years
Data Required to Quote	The process is SLOW. Please allow additional time for processing. Typically up to 3 weeks • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Ukrainian • Certificate of Incorporation of Sponsor (for new Sponsors in Ukraine only) • Name and Title of Authorized Signatory who will countersign policy • Name of document which gives the Signatory the authorization to countersign the policy. (i.e. Charter, Power of Attorney, Resolution by the Board of Directors) - Ukraine requires payment and payment confirmation documentation PRIOR to release of certificate - No refund for policy cancellation - Original documents are not required to be delivered to the local CRO. Only require copy of the Certificate which is issued by the carrier once the premium has been received

Clinical Trial Application	Italy Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes
Standard Limits	For Medical Device studies limits are: 1.000.0000 €/patient 2.5 to 10.000.000 €/protocol depending upon the size of the trial For Drug Studies limits will depend on the number of patients : 5.000.000 €/protocol up to 50 patients 7.500.000 €/protocol from 51 to 200 patients 10.000.000 €/protocol for more than 200 patients
Tail Coverage	For Medical Device Studies: 2 years (up to 5 years potentially available) For Drug Studies: => Successor liability: The Damage (bodily injury) must occur within 24 months after the end of the study => Extended reporting period: A Claim must be made by a patient within 36 months after the end of the study If the study involves gene therapy, cellular therapy, radio-pharmaceuticals or children, carriers are required to issue policies with tail coverage of at least 10 years. For the latter i.e. children, carriers issue 10 years irrespective if the study also involves adults
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in Italian • Site List is preferable in Italian, but English is acceptable, 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.