Australia

Clinical Trial Application	Australia Clinical Trial Quote Request
Mandated Coverage	No, but is typically preferred by EC
Standard Limits	AUD 10M or AUD 20M depending on territory where study is taking place. PLEASE CONFIRM WITH YOUR CRO for limit required
Tail Coverage	12 months but 72 months in respect of Western Australia and/or Queensland.
Data Required to Quote	• Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO or Institution name (Contact Person Name, Address, Telephone Number and E-Mail Address) • Local CRO GST (Goods and Services Tax) Number. ABN (Australian Business Number) is also sufficient If Sponsor has a local entity to be listed without the Local CRO on policy, a Goods & Services Tax (GST) will be required for the local sponsor entity. If none available, there is a tax implication. The same trial in New Zealand can be added to this policy for additional premium. Please check with your CRO beforehand to advise if a shared policy is acceptable.

Clinical Trial Application	Nigeria Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. It is recommended that Sponsor use an experienced or local CRO in Nigeria
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	Process is SLOW in Nigeria. Please allow for additional time. Submission should be made at least one month before documents are required • Clinical Trial Quote Request • Protocol and Informed Consent Form in English • Local CRO details (Contact Person Name, Address, Telephone Number and E-mail Address) • Completed, signed and dated Clinical Trial Proposal form (To be provided separately) • Provide completed Anti-Money Laundering document which is required (To be provided separately) - Regulatory Approval (RA) from the National Agency for Food & Drugs Administration and Control (NAFDAC), which can be provided after release of the policy documents, but is absolutely required unless the Sponsor does not have approval at the time of submission - Nigeria requires a local quotation so the premium will be subject to change by the local Nigerian office - Nigeria is a cash before cover country, which means Policy documents only released after premium payment received by the carrier; Sponsor pays the Carrier directly once invoice is provided and Carrier will confirm receipt of funds - No refunds for policy cancellation