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Clinical Trial Research Agreements

Comprising of NSW, QLD, VIC, SA and TAS Health Departments the South Eastern Border States (SEBS Committee), together with Medicines Australia have developed five Clinical Trial Research Agreements (CTRAs). Consulting with Medicines Australia’s stakeholders and discussion with the SEBS Committee, four Clinical Trial Research Agreements have been revised and updated. From these discussions it was also evident that an additional Agreement was required for Phase 4 Clinical Trials where a Contract Research Organisation is acting as the Local Sponsor. The revised templates along with the new Phase 4 CRO template are available below:

*Note for Tasmania: The Tasmanian Department of Health and the Tasmanian Health Service are bound to follow Treasurer’s Instruction 1401 (TI 1401). Tasmanian approved CTRAs must have amendments inserted into Schedule 7 or Schedule 4 ‘Special Conditions’, as appropriate, to provide clarity and ensure full compliance with TI 1401. For more information or for Tasmanian approved CTRAs please see www.dhhs.tas.gov.au/research

Transition arrangements

The previous versions of the CTRA templates have been archived here (please follow link)

Guidance for seeking amendments to the Clinical Trial Research Agreements

If no amendments are being sought to either of the five template CTRAs a SEBS review is not required.

The SEBS Committee will consider CTRA amendments that are intended to accommodate (to an extent) company specific clauses that clarify or add to the CTRAs. Please note that SEBS will not accept amendments that:

  • are clearly contrary to, or attempt to modify, the core provisions of the CTRAs;
  • seek to delete or substantially modify the essential clauses of the CTRAs. These include the provisions surrounding Publication, Confidentiality, Intellectual Property, Governing Law and Termination;
  • merely restate (or “wordsmith”) the existing provisions of the CTRAs;
  • seek to override the applicability of the CTRAs;
  • are contrary to government insurance arrangements or seek to require the Institution to have certain types of insurance. All Public Health Institutions in Australia have standard insurance arrangements that apply to the whole of the Government sector for each State;

A request template for amendment of a CTRA has been developed by the SEBS Committee, which is below:

The completed variation request template should initially be submitted to Health Ethics Unit, NSW Health, who will coordinate with other members of the SEBS Committee:

Initial Contact Point for Submissions:

Please forward all contract variation requests to the above email and the SEBS secretariat will appoint a Committee Member as the liaison officer for that request. The SEBS Committee meets monthly to review submitted variation requests, below are the closing dates for submissions along with the meeting dates for 2018:

Closing Dates for Submissions and Meeting Dates for 2018:

2018 Meeting Dates
COB 5 February 2018 14 February 2018
COB 13 March 2018 21 March 2018
COB 9 April 2018 18 April 2018
COB 14 May 2018 23 May 2018
COB 18 June 2018 27 June 2018
COB 16 July 2018 25 July 2018
COB 13 August 2018 22 August 2018
COB 17 September 2018 26 September 2018
COB 15 October 2018 24 October 2018
COB 19 November 2018 28 November 2018
COB 10 December 2018 19 December 2018

Standard Clause: Extending Third Party Beneficiary rights to International Organisations

The Medicines Australia CTRAs, in alignment with TGA regulation, require the Sponsor of a trial to be an Australian legal entity. Accordingly, and to minimise the legal risk on behalf of its Institutions, SEBS Committee policy is to agree only to Australian legal entities as contracting parties in any CTRA they negotiate. This includes not accepting proposed amendments to the CRO CTRA that seek to include the international Organisation as a principal contracting party in a tripartite arrangement. The SEBS Committee has agreed to standard wording for the extension of third party beneficiary rights to international Organisations. The agreed wording is available here:

Although the SEBS Committee has agreed upon the wording of the third party beneficiary clause, if a sponsor wants to include this clause in Schedule 7 or Schedule 4 you should still complete the template to request a Schedule 7 or Schedule 4 variation to a CTRA as described above.

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