Insurance and Indemnity

 All clinical trials conducted at Sydney Local Health District must have adequate insurance and indemnity arrangements in place prior to commencement of the trial, in accordance with NSW Policy Directive ‘Clinical Trials - Insurance and Indemnity’ (PD2011_006).

Insurance and indemnity arrangements (excluding HREC only indemnity) are to be reviewed as part of Site Specific assessment (SSA) undertaken by each public health organisation at which a clinical trial is conducted.

Commercial Sponsor requirements

For drug clinical trials, a commercial sponsor must provide:

• Standard Clinical Trial Research Agreement (see CTRA section of website here)
• Standard Medicines Australia Indemnity
• Insurance Certificate (The insurance certificate should: Cover a minimum of $20 million (AUS); have an Australian-named sponsor; and an excess/deductible or self-insured retention amount not greater than $25,000 for each and every claim)

Non-commercial sponsor requirements

NSW Health Staff: NSW Health, through the Treasury Managed Fund (TMF), provides cover for the Sponsor-related liabilities of clinical trials initiated by NSW Health Staff and conducted at the public health site. Insurance and indemnity per above are not required. NSW Health Staff includes:

• staff specialists;
• Visiting Medical Officers and Honorary Medical Officers with a signed, current Services Contract and Contract of Liability Coverage;
• Clinical Academics;
• employed non-specialist medical practitioners (interns, registrars, career medical officers);
• non-medical practitioner employees (employed nurses, allied health care workers etc), and
• nurses engaged by a PHO through an agency who are paid as NSW Health award employees through payroll.

Non-NSW Health Staff: The TMF contract of coverage does not extend to professional liabilities of non-NSW Health persons who conduct the study at the public health organisation. Unless covered by their employer, such as a university or a research institute, medical practitioners must hold a separate professional indemnity cover from a recognised organisation that includes cover for the conduct of clinical trials within the category of practice for which the practitioner is insured.

Any Non-NSW Health Staff coming on site to SLHD or accessing SLHD patients and/or their data will require Contingency Worker Status.

For investigator-initiated clinical trials that include public health organisations outside of SLHD, each site must be sponsored by their own local health district or institution and should take on all sponsor-related liabilities, including submitting their own CTN to the TGA.

Collaborative or cooperative research group sponsors must provide:

• Standard Clinical Trial Research Agreement (see CTRA section of website here)
• Sponsors must have indemnity or insurance arrangements that are sufficient to cover their Sponsor-related liabilities associated with clinical trials to be conducted at sites under their control.

Institution Details
For any site within SLHD where the trial is taking place, the institution's details should be entered as follows on a Research Agreement:

Name of Institution: Sydney Local Health District
Address:  Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
ABN: 17 520 269 052