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Clinical Trial Research Agreements

The NSW, Qld, Vic and SA Health Departments (the SEBS States), together with Medicines Australia, have developed five 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.

Following consultation with Medicines Australia’s member companies and discussion with the SEBS Representatives, the four original Clinical Trial Research Agreements have been recently revised and updated.  In addition a new Agreement has been prepared for Phase 4 Clinical Trials with a Contract Research Organisation Acting as the Local Sponsor.  The revised templates and the new Phase 4 with a CRO as the Sponsor template, dated March 2017, are now available below:

Transition arrangements

Companies and other sponsors of clinical trials may start to use the updated CTRA templates from 1 May 2017.

There is no need to revise the CTRA for any clinical trial which has already been submitted to an HREC for review, or for any clinical trial that has commenced.

Between 1 May 2017 and 31 July 2017 companies and other sponsors of clinical trials may choose to either use the current (November 2012/March 2013) versions of the CTRA templates or the March 2017 versions for new clinical trial projects.  Both are acceptable.

For all new clinical trials for which submissions to HRECs will be made on or after 1 August 2017, the March 2017 CTRA templates must be used.

In relation to any amendments to the template CTRAs that have previously been approved by the SEBS for inclusion in Schedule 7 (or Schedule 4 in the case of the CRG and Phase IV templates), these amendment clauses do not need to be re-approved.  This includes if there is a change to the numbering of the relevant clause – companies and other sponsors may simply change the numbering as required, retaining the same wording as previously approved by the SEBS Committee.

The five 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”.

The previous versions of the CTRA templates have been archived here (please follow link)

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
Phone: (02) 9461 7344

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 2017:

Closing Date for Submissions Meeting Dates
COB 6 February 2017 16 February 2017
COB 13 March 2017 23 March 2017
COB 10 April 2017 19 April 2017
COB 8 May 2017 17 May 2017
COB 12 June 2017 21 June 2017
COB 10 July 2017 19 July 2017
COB 7 August 2017 16 August 2017
COB 11 September 2017 20 September 2017
COB 9 October 2017 18 October 2017
COB 6 November 2017 15 November 2017
COB 11 December 2017 20 December 2017

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.