Oman

Clinical Trial Application	Oman Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes, in most cases. Some ECs may accept the Master policy as evidence of coverage
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Legal Representative details (Contact Person Name, Address, Telephone Number and E-Mail Address) • Signed and completed Hold Harmless Agreement (to be provided separately by ABD Life Science team) • Copy of the entity’s Commercial Register showing evidence that local company/entity is policy holder - Oman requires a local company/entity to be the policy holder. - Anti-Money Laundering regulations for Oman require that carriers provide evidence the policy holder is a registered company/entity in Oman – a copy of the entity’s Commercial Register - No refund for policy cancellation

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.