Netherlands

Netherlands Clinical Trial Quote Request

Clinical Trials Quote Request

Yes. www.ccmo.nl/en/insurance

450.000 €/patient
3.500.000 €/protocol

Effective July 1, 2015, new limits required are:
650.000 €/patient
5.000.000 €/protocol

4 years from the end of patient treatment

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Dutch

- There are TWO insurance requirements.
- Local admitted clinical trial insurance satisfies the G1 patient indemnity insurance requirement according to WMO
- The G2 is the liability insurance of Sponsor, which can be covered via a global product liability policy
- Therefore to satisfy G2, if the Sponsor has a Master Product Liability policy through Newfront, Newfront can provide a certificate

Russia Clinical Trial Quote Request

Clinical Trials Quote Request

Yes

1 – in the case of death of patient, the claim payment in the specified amount is equally distributed between the Beneficiaries in proportion to their number:
2 000 000 RUR
2 – in case of deterioration of health (different degrees). Limits (3 disability groups):
group 1 : 1 500 000 RUR
group 2 : 1 000 000 RUR
group 3 : 500 000 RUR
3 – in case of deterioration of health not resulting in the assignment of a disability group, – not more than 300.000 RUR
The amounts of claim payments specified above may be increased on the basis of an effective legal decision

2 years

THE PROCESS IN RUSSIA IS SLOW. PLEASE ALLOW UP TO TWO MONTHS FOR DOCUMENTS TO BE PROCESSED. Please provide all documentation outlined below otherwise the process is further delayed.

• Clinical Trial Quote Request
• Protocol and Informed Consent Form in English
• Protocol Title in Russian
• Sponsor/Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) required to bind coverage

1. Provide copy of the MoH approval letter once coverage is bound and insurance documentation provided. MoH approval letter required in order for the carrier to issue individual patient policies
2. Please note that the individual patient policies are sent directly from the carrier to the CRO for distribution to the clinical sites
3. Sponsor will not receive copies of the completed individual policies as these are kept at the clinical site file with a copy given to the patient
4. On a quarterly basis, the CRO is to provide the Sponsor with a list of IICPs (these are the numbers generated and necessary to protect the patient's privacy).
5. Once provided to the carrier, the carrier will endorse the list of IICPs onto the Policy
Sponsor will receive a draft copy of the individual policy(ies). The original policy(ies) will only be issued once premium payment has been received and the MoH approval letter has been provided

- Sponsor must provide a wire confirmation once premium is paid
- No refund for policy cancellation