Research Ethics and Governance Office

Clinical Trial Agreements/Indemnity and Insurance

Clinical Trial Agreements
A clinical trial research agreement should be provided in accordance with NSW Ministry of Health policy directives:
• Clinical Trial Research Agreements for Use in NSW Public Health Organisations (PD2011_028)
Each clinical trial to be conducted at site(s) under the control of a NSW Public Health Organisation and sponsored by an entity external to that Public Health Organisation must be governed by a written agreement clarifying the obligations, responsibilities and rights of the parties involved in the trial.
• These agreements can be found at:
- Only these most recent versions will be acceptable.
- If an older version is used the documents will be returned to the Investigator with a request for the correct versions to be used.

• The institution's details should be entered as follows:
 Name of Institution: Sydney Local Health District
Address: Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
ABN: 17 520 269 052

• No changes should be made to the body of the CTRA.
• The footer should remain as is and only the relevant information inserted for Protocol Number and Site.
• Changes shown in Schedule 7 or Schedule 4 should conform with the clauses pre-approved by the South and Eastern Border States including the NSW Ministry of Health's Legal Branch.
• A request template and instructions on how to request an amendment to a CTRA has been developed by the SEBS Committee and it is available on the Medicines Australia website.

Medicines Australia Standard Forms of Indemnity and Insurance
At least three (3) signed copies of a form of indemnity must be provided by the sponsor.
• The document must be in the standard Medicines Australia format
• It must be the most recent version available on the Medicines Australia website
• The document must be prepared as follows:

To: Sydney Local Health District, Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050 – ABN 17 520 269 052
From: [The sponsor's company name]
• Clause 1: This should be completed in accordance with the options provided.
The Form of Indemnity must be supported by a current Certificate of Insurance as per the NSW Ministry of Health Policy Directive Document Number (PD2011_006).

The Certificate of Insurance must list:
- Cover of AUD$20 million for commercially sponsored research
- Cover of AUD$10 million for collaborative or co-operative research groups
- Must be in Australian Dollars
- Must state cover for clinical trials
- Must state an Australian Insurer’s name and Australian address