Germany

Clinical Trial Application	Germany Clinical Trial Quote Request Germany Business Travel Accident Application (OPTIONAL) Clinical Trials Quote Request Go to Form
Mandated Coverage	Yes - Local Policy Required
Standard Limits	500.000 €/patient is typically mandatory 5 to 50.000.000 €/protocol (varies and is dependent upon review by the carrier and often driven at the request of the Ethics Committee)
Tail Coverage	5 years for the damage 10 years for the claim
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Protocol Title in German • Provide EudraCT Number for Drug studies or EUDAMED No. for Medical Device studies, if not already included in Protocol - When the trial is completed, both the number of treated and the number of screened patients are required by the carrier and this may result in additional premium If you need to obtain a Germany Business Travel Accident policy, please note the process is VERY slow to obtain the certificate and policies so please allow plenty of time. In addition to the completed Travel Accident application, please provide the number of trips each subject will make.

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.