Clinical Trial Guidelines

The VMIA is keen to promote and be an integral part of the clinical trial scene within the state of Victoria and fully supports the State Government's agenda in this regard. The VMIA aims to assist its client base by providing Clinical Trials Notification Scheme (CTN) guidelines that will ensure compliance with the VMIA medical indemnity policy and assist ethics committees and investigators in the preparation and review of clinical trials.

Please find below the updated 2009 CTN guidelines with the updated attachment B Form of Indemnity for Clinical Trials and updates incorporating amendment to the Guardian and Administrative Act 1986.

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Clinical Trial Research Agreements

The VMIA in collaboration with interstate health departments and industry agencies developed a set of uniformly accepted standard Clinical Trial Research Agreements (CTRA) that accommodate for individual Local Sponsor and International Organisation operational requirements through the nominated Schedule.

The CTRA is between the Local Sponsor and the Investigating Institute. The Local Sponsor is the Australian entity that endorses the CTN application.

Sponsor of the trial

The sponsor of the trial is the company, institution or organisation, that takes overall responsibility for the conduct of the trial and usually initiates, organises and supports a clinical study of an investigational product in human subjects. The sponsor of the trial should be an Australian company or entity.

The defined Australian entity that endorses the CTN Application will be the LOCAL SPONSOR. In this capacity they must provide the indemnity and required insurance provisions for the conduct of the clinical trial.

Commercially Sponsored CTRA:

• The Commercially sponsored CTRA is to be used when an Australian pharmaceutical company or the Australian subsidiary of an international pharmaceutical company providing the investigational product acts as the Local Sponsor for the purposes of the clinical trial.

• The Commercially Sponsored CTRA is between the Local Sponsor and the Investigating Institute.

At no stage should the body of the Commercially Sponsored CTRA be altered or amended in any way. Any changes that are required to be inserted into the Agreement to accommodate operational specific requirements need to be captured & declared through Schedule 7.

Corporate Research Organisation (CRO) CTRA

• The CRO CTRA is to be used when the International Organisation as owner of the investigational product engages a CRO to act as the Australian entity for the purposes of the CTN application. The CRO is then defined as the Local Sponsor and assumes all responsibilities and obligations that attach to a Local Sponsor.

As the Local Sponsor, the CRO must:

• Provide the Medicines Australia Form of Indemnity
• Provide appropriate insurance. - It is acceptable for the CRO to be a named additional insured under the International Organisation’s insurance policy

• The CRO as Local Sponsor may subcontract certain key functions of the clinical trial to an other entity. Under Schedule 7, the CRO CTRA can utilize the Subcontracting clause provided below.

At no stage should the body of the Commercially Sponsored CTRA be altered or amended in any way. Any changes that are required to be inserted into the Agreement to accommodate operational specific requirements need to be captured & declared through Schedule 7.

Collaborative Research Agreements (CRG CTRA)

• The CRG CTRA is to be used when a collaborative/cooperative group is the sponsor of the Clinical Trial.

• The CRG as local Sponsor may subcontract certain key functions of the clinical trial to an other entity. Under Schedule 4, the CRG CTRA can utilize the Subcontracting clause provided below.

At no stage should the body of the Commercially Sponsored CTRA be altered or amended in any way. Any changes that are required to be inserted into the Agreement to accommodate operational specific requirements need to be captured & declared through Schedule 4.

Schedules 7 & 4

Schedule 7 & 4 is to be utilised for the introduction of sponsor unique operational requirements that are required to be executed in order to allow for the conduct of the clinical trial.

Schedule 7 & 4 are not to be used to substantially amend the CTRA or to introduce provisional clauses which contradict or otherwise undermine the substantial provisions and spirit of the Agreement.

The VMIA has pre-approved a number of Schedule 7 requests from industry for the commercially sponsored CTRA. The approved Schedule 7 clauses have been issued to both the health services and the respective pharmaceutical company. The CTRA must only contain the Schedule 7 accepted clauses that have been issued to the pharmaceutical company as approved by the VMIA.

Subcontracting

The following amended Subcontracting clause can be inserted into Schedule 7 for the CRO CTRA and Schedule 4 for the CRG CTRA.

• The Sponsor may subcontract any of its obligations under this Agreement, save for the obligations set out in clauses 5.1(8), 5.1(9) and 5.1(10) of the Agreement. The Sponsor remains responsible for all subcontracted obligations and is liable for all acts and omissions of any subcontractor as if they were the Sponsor's acts and omissions.
• No subcontractor will have any rights under this Agreement against the Institution or be entitled to receive any payment from the Institution.

The VMIA strongly encourages its insured to use the CTRA Agreements for all sponsored trials to ensure that cover under the VMIA policy is not compromised.

For all queries pertaining to this matter please contact Bill Karanatsios at b.karanatsios@vmia.vic.gov.au or by phoning (03) 9270 6926.

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First Time in Human Protocol

The Clinical Trial Guidelines has been prepared in order to assist ethics committees and investigators in the preparation and review of clinical trials. Adherence to the requirements outlined and use of the forms and documentation will help reduce the risk profile for HRECs and investigating institutes in relation to the conduct of FTIH clinical trials. This document is intended to be used as a guide only.

An expert reviewer database can be requested by contacting the Department of Human Services on the website below:

www.health.vic.gov.au/ethics

For all queries pertaining to this matter please contact Bill Karanatsios at b.karanatsios@vmia.vic.gov.au or by phoning (03) 9270 6926.

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13 Standard Operating Procedures (SOPs)

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New Projects: Research Governance Framework

The VMIA is currently engaged in a program of consultation with its clients with the aim of developing a framework that will provide policies, tools and guidelines to its clients to facilitate expedition of clinical research conduct.

Drawing on the expertise within its client base, the VMIA Research Governance Framework (RGF) will provide the essential elements in an integrated manner, ensuring that institutes have easy access to required guidelines, templates and SOPs to facilitate the implementation and ongoing support of the RGF.

The core elements that will be represented in the RGF are:

• Ethical Review
• Good Clinical Practice
• Data and Tissue Management
• Intellectual Property & Publication Management
• Financial Management
• Risk Management
• Legal & Insurance

This framework will be made available from late October 2009.

For all enquiries, please contact Bill Karanatsios b.karanatsios@vmia.vic.gov.au

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Resources

Presentations from past seminars can be accessed below.

Contact Bill Karanatsios at b.karanatsios@vmia.vic.gov.au or (03) 9270 6926.

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