The Southern and Eastern Border States (forming the SEBS Panel) (comprising the NSW, QLD, VIC, SA and TAS jurisdictions with ACT and NT as observers) together with Medicines Australia have developed five Clinical Trial Research Agreements (CTRAs) as listed below, that are available for use by any sponsor and/or institution for specific clinical trial scenarios.

The SEBS Panel has also developed standard Clinical Investigation Research Agreement (CIRA) templates with the Medical Technology Association of Australia (MTAA), available here.

Clinical Trial Research Agreement – Medicines Australia Standard Form

Clinical Trial Research Agreement – CTRA: Contract Research Organisation acting as the Local Sponsor

Clinical Trial Research Agreement – Collaborative or Cooperative Research Group (CRG) Studies

Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines)

Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines) Contract Research Organisation acting as the Local Sponsor

*Note: Please ensure you are using the most current version of documents found on this page. The most recent version of the Clinical Trial Research Agreement – Medicines Australia Standard Form, was updated in 2017 and should have the title “Clinical-Trial-Research-Agreement-Medicines-Australia-Standard-Form-8-March-2017-b-2”. Schedule 3.3 (1) and (8) should have the words “his or herself” replaced with “themselves/their”; and 4.10 where the text has been changed to “…written approval of the Sponsor.” Using out-of-date forms may cause delays in executing CTRAs.

*Note for Tasmania: The Tasmanian Department of Health and the Tasmanian Health Service are bound to follow Treasurer’s Instruction, Contracts – Disclosure and Confidentiality in Government Contracting, issued under the Financial Management Act 2016 (Tas) (“TI C-1”). Tasmanian CTRAs must have amendments inserted into Schedule 7 or Schedule 4 ‘Special Conditions’ as appropriate, to provide clarity and ensure full compliance with “TI C-1”. For more information, to discuss SEBS approvals prior to Tasmania joining SEBS or for Tasmanian approved CTRAs please see www.dhhs.tas.gov.au/research

*Note for the Northern Territory: The Northern Territory of Australia through its agency the Department of Health, is required to comply with the Northern Territory Treasurer’s Direction G2.5 (TD G2.5). Approved Northern Territory CTRAs must include specific amendments in Schedule 4 or Schedule 7 ‘Special Conditions’, as appropriate, to provide clarity and ensure full compliance with TD G2.5. For more information on the amendments or to obtain a Northern Territory approved CTRA version please see https://health.nt.gov.au/data-and-research/nt-health-research/clinical-trials

Guidance for seeking amendments to the Clinical Trial Research Agreements

No amendment required

The CTRA templates do not require any amendments to function as legally enforceable agreements. If no amendments are required to the subject CTRA, a SEBS review is not required.

Approaching SEBS

Changes to the existing clauses in the body of the template CTRAs should go to SEBS Panel for review.

Although review by the SEBS Review Panel is not mandatory to amend the Schedule 4/Schedule 7 Special Conditions section, the service is recommended to assist clinical trial sponsors with timely, standardised review, where only one negotiation is required, rather than several.

Amendments to the template CTRAs that DO NOT require SEBS review:

Where parties need to fill in study-specific information to complete the details of the agreement for their study without changes made to the existing texts of the Contract, SEBS review is not necessary.

Study-specific information needs to be entered in:

• The Front Page information;
• Schedule 1 – Key information;
• Schedule 2 – Payments;
• Schedule 6 – Study Protocol Information.

Amendments that are not acceptable

The SEBS Panel 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;

Some common requests and the SEBS suggested resolutions

(i) Third Party Payor

A number of Sponsor companies choose to use a third party to pay invoices from the Institution related to the trial. SEBS is reluctant to include the third party payor as a party in the CTRA, as this would create a contractual relationship between the Institution and the payor, which the Institution would be obliged to enforce in the event of non-payment. SEBS takes the view that the Sponsor (including CRO sponsor in the CRO CTRA) must maintain the legal obligation to pay the Institution, even if, in fact payment is being received by the Institution from a third party.

Resolution

In accordance with clause 6.1, parties should use Schedule 2 to describe “the manner” in which the Sponsor will pay the Institution (ie/ through a third party payor). Institutions should ensure that invoices are made out to the Sponsor (with whom they have a contract) and sent “care of” the payor (who will pay the invoice).

(ii) Studies in which there is no product

While the interventional CTRA templates (Standard, CRO and CRG CTRAs) anticipate a contractual arrangement where there is a clinical trial, conducted under the TGA’s CTN or CTX schemes, in accordance with GCP that involves an investigational product (an unapproved therapeutic good); SEBS understands that, for convenience, parties wish to use the templates to accommodate a trial where no investigational product is being used. SEBS is reluctant to make wholesale amendments to the templates, such as striking out all clauses that refer to Investigational Product, as the Panel believes this is unnecessary.

Resolution

In Schedule 1, parties should write in the ‘Investigational Product’ field: “There is no Investigational Product being used in this Study”.

Because the definition of Investigational Product (in Clause 1 ‘Interpretation’) refers directly to the description in Schedule 1, entering such a description renders all obligations relating to Investigational Product in the body of the CTRA to automatically fall silent.

(iii) Collaborative clinical trials supported by a Grant Funding Agreement

The Panel has worked with University partners to develop two variations of a set of clauses that can be used when a non-commercial sponsor receives grant funding for a trial through a Funding Agreement (from NHMRC, MRFF or Cancer Australia) and wishes to pass through some of those obligations onto the institution. The variations consist of clauses for each funder with the CRG CTRAs. The clauses are included in Schedule 4 in the usual way. Please see these clauses here:

1. CRG-CTRA Cancer Australia V4 Schedule 4 (December 2021)
2. CRG-CTRA Cancer Australia V5 Schedule 4 (December 2021)
3. CRG-CTRA MRFF NHMRC Schedule 4 (December 2021)
4. CRG-CTRA NHMRC Schedule 4 (December 2021)

Application to SEBS

A template to request an amendment of any of the Medicines Australia suite of CTRAs for review by SEBS panel has been developed by the SEBS Panel and is below:

Template to request a Schedule 7 or Schedule 4 variation to a CTRA (SEBS Review Template)

Statement of Purpose for SEBS

Initial Contact Point for Submissions:

• Phone – (02) 9391 9854
• SEBS email address – MOH-SEBS@health.nsw.gov.au.

Please forward all contract amendment requests to the above email (Research Ethics and Governance Unit, NSW Ministry of Health) who are the SEBS secretariat who will then appoint a Panel Member as the liaison officer for that request. The SEBS Panel meets monthly to review submitted amendment requests. Below are the closing dates for submissions along with the meeting dates for 2021:

Closing Dates for Submissions and Meeting Dates for 2022/2023:

Once a set of clauses has been agreed between the Panel and the applicant, the SEBS jurisdictions will each prepare an approval letter accompanied by the approved clauses and will email these in PDF form to the applicant’s contact person.

The applicant should then submit the jurisdiction-specific letter and approved clauses to that jurisdiction’s sites (ie/ send the NSW approval letter and clauses to all participating NSW sites; Victorian letter and clauses to Victorian sites, etc), as part of their site-specific assessment application.