Clinical trial ethical approval

Clinical trials require additional documentation for Human Research Ethics Committee (HREC) review and approval.

Clinical Practice Documents

Investigator’s Brochure/s

Product information or an Investigator Brochure (IB) is required for all drug and/or device trials. An IB is a compilation of the clinical and nonclinical data for the investigational product(s) being trialled in the study and provides the rationale for key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. If more than one version of the IB has been approved by the HREC, provide the most recent approved version.

Teletrial requirements

Projects intending to run as a teletrial require the following:

• CV of Associate Investigator at Satellite Site (operating under the PI)
• Principal Investigator statement that they are satisfied that the Associate Investigator is suitably qualified to undertake the role of Associate Investigator at a Satellite Site – this can be by way of the cover letter
• Certificate of Good Clinical Practice for Associate Investigator
• Evidence of Sponsor Agreement for the inclusion of this site
• Master versions of all PICFs must include the optional Teletrials Specific Wording for review by the HREC.  This wording may be omitted for those sites not participating in the teletrials model.
• The Sponsor agreed process by which consent will be obtained at Satellite Sites must also be provided to the HREC

Supporting Resources

• The Australian Teletrial Program
• Teletrials checklist

Clinical Trial Notification (CTN)

Any research using an approved drug or device or an approved drug in a manner (dose or cohort) that is approved as per the Australian Register of Therapeutic Goods (ARTG) must provide copy of the eCTN registration with the application.

Insurance

Where clinical trials involve collaborators or parties external to Queensland Health, the contract must include reference to insurance and indemnity arrangements.  

For commercially sponsored research, the relevant Medicines Australia Clinical Trial Research Agreement (CTRA) and Medical Technology Association of Australia Clinical Investigation Research Agreement contain clauses relating to the Insurance to be provided for the project.  

Certificates of Currency (insurance certificates) should be submitted with the research governance application, and their expiry dates noted to ensure there is no lapse in cover. There are no requirements for specific insurance companies to be used, but the insurance company should have offices or representatives in Australia to facilitate processing of any claims that may be made. 

The certificate of currency (or insurance certificate) should contain the following information: 

• Full Study Title
• The type of insurance – Public and Product Liability – or equivalent such as General Liability or Clinical Trials Insurance
• The full legal name of the Australian entity acting as the sponsor
• The full legal name of the insurer (which must be approved by the Australian Prudential Regulation Authority or a foreign equivalent). All insurers are required to hold Standard & Poor’s financial rating of not less than ‘A-’.
• The period of insurance
• That the insurance coverage allows for a minimum of AUD$10 million for any one occurrence and in the annual aggregate

For collaborative or other non-commercial clinical trial, each institution will generally provide their insurance for the project. The Medicines Australia CTRA – Collaborative Research Group (CTRA -CRG) contains specific clauses covering this. 

Generally speaking, Queensland Health will not provide insurance or indemnity for external parties.