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Clinical Trials Research Agreements

The NSW, Qld, Vic and SA Health Departments (the SEBS States), together with Medicines Australia, have developed four Clinical Trial Research Agreements (CTRAs) in order to provide template agreements that are fair and reasonable for both sponsors and institutions and provide certainty of application in the commercial trial environment. Some of the individual clauses have been the subject of long negotiation through this process.

The current versions of the Clinical Trials Research Agreement are available below:

The four Clinical Trial Research Agreements are available as unlocked Word 97-2003 documents. In using the standard CTRAs note in particular that: “Any textual change to the body of this Agreement is to be ignored, and reference instead had to the standard form, as amended by Schedule 7 (or Schedule 4) by way of Special Conditions”.

Guidance for seeking amendments to the Clinical Trial Research Agreements

The template CTRAs can be executed without the need for any amendments via Schedule 7 (or Schedule 4 in the case of the CRG and Phase IV templates). This is preferable for SEBS jurisdictions, as there will be no requirement to involve the SEBS Committee, and SEBS Institutions can accept the unmodified CTRAs without requiring further legal review and therefore imposing further delays.

The SEBS Committee will consider contract amendments that are intended to accommodate, as far as possible, company-specific clauses that clarify or add to the CTRAs. However, the SEBS Committee 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 available here.

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:

Research Ethics at NSW Office for Health and Medical Research
RESEARCHETHICS@doh.health.nsw.gov.au
Phone: (02) 9391 9228

At the SEBS Committee meeting which considers the contract variation request, one jurisdiction member will be appointed as the liaison officer for that request. The sponsor requesting the contract variation will be informed that a jurisdiction representative will be in contact regarding the variation request.

The SEBS Committee meets monthly to consider the variation requests. Variation requests should be submitted by COB on the Monday 9 days prior to the meeting, which is held on the Wednesday of the following week, to ensure that the request can be included on the Committee’s agenda.

Closing Dates for Submissions and Meeting Dates for 2016:

Closing Date for Submissions Meeting Dates
COB 8 February 2016 17 February 2016
COB 8 March 2016 16 March 2016
COB 11 April 2016 20 April 2016
COB 9 May 2016 18 May 2016
COB 6 June 2016 15 June 2016
COB 11 July 2016 20 July 2016
COB 8 August 2016 17 August 2016
COB 12 September 2016 21 September 2016
COB 10 October 2016 19 October 2016
COB 7 November 2016 16 November 2016
COB 12 December 2016 21 December 2016

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.