Clinical Trials & non-Clinical Trial Collaborative Research Agreements

 Background

Clinical trials that are conducted at a NSW Health public health organisation (e.g. public hospital) and are sponsored by an external sponsor must have a clinical trial agreement in place, in accordance with NSW Health Policy Directive ‘Research - Authorisation to Commence Human Research in NSW Public Health Organisations’ (PD2010_056). The purpose of the clinical trial agreement is to outline the obligations, responsibilities and rights of the parties involved in the trial.

NSW Health, together with key stakeholders, have developed a number of standard Clinical Trial Research Agreements and Clinical Investigation Research Agreements, which are designed to be used for certain clinical trials. These Research Agreements are outlined in NSW Health Policy Directive ‘Research Agreements in NSW Health Organisations’ (PD2023_017).

The Research Agreements are designed for use by different types of sponsors of clinical trials as well as for different clinical trial phases including:

• Pharmaceutical companies
• Contract research organisations
• Medical device companies
• Collaborative or cooperative research groups
• Pre-approval (phase I-III) clinical trials
• Post-approval (phase IV) clinical trials

For investigator-initiated clinical trials where sponsorship has been sought from the Sydney Local Health District, no Research Agreement is required.

Submission

The Research Agreement should be submitted with the initial Site Specific Assessment (SSA) application via REGIS. The agreement must be signed by the sponsor and Principal Investigator prior to submitting it with the SSA application. Any amendments to the agreement post-authorisation can be submitted as a site amendment via REGIS. See our website for governance submission guidelines here: https://www.slhd.nsw.gov.au/rpa/research/ctssa.html

Institution Details

For any site within SLHD where the trial is taking place, the institution's details should be entered as follows on a Research Agreement:

Name of Institution: Sydney Local Health District

Address:  Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

ABN: 17 520 269 052

Clinical Trial Research Agreements (CTRA) – Pharmaceuticals

Clinical Trial Research Agreements (CTRA) have been developed for sponsored pharmaceutical clinical trials. Please note that the sponsor listed on the agreement must be an Australian entity.

The following CTRA templates are available on the Medicines Australia website:

•  Commercial sponsor: Standard Medicines Australia Clinical Trial Research Agreement (CTRA) for commercially sponsored trial – to be used when a commercial  pharmaceutical company is sponsoring a clinical trial

• Contract Research Organisation (CRO): Standard Medicines Australia Clinical Trial Research Agreement (CTRA) for Contract Research Organisations acting as the Local Sponsor – to be used when a contract research organisation is sponsoring a clinical trial on behalf of an international sponsor

• Collaborative or Cooperative Research Group (CRG): Collaborative or Cooperative Research Group (CRG) Studies Clinical Trial Research Agreement (CTRA) – to be used when a non-commercial entity, including a collaborative or cooperative research group (research group), is sponsoring a clinical trial

• Phase 4 commercial: Standard Phase 4 Clinical Trial (Medicines) CTRA – to be used for Phase 4 drug trials sponsored by a commercial entity

• Phase 4 CRO: Standard Phase 4 Clinical Trial (Medicines) Contract Research Organisation Acting as the Local Sponsor CTRA – to be used for Phase 4 drug trials where a Contract Research Organisation assumes all of the responsibilities of a local commercial sponsor

Clinical Investigation Research Agreements (CIRA) – Devices

The Medical Technology Association of Australia (MTAA) have developed Clinical Investigation Research Agreements (CIRA) for sponsored device clinical trials. Please note that the sponsor listed on the agreement must be an Australian entity.

The following CIRA templates are available on the MTAA website:

• Commercial sponsor: MTAA Standard Clinical Investigation Research Agreement (CIRA) – to be used when a medical device company is sponsoring a clinical trial

• Commercial sponsor post market: MTAA Standard Clinical Investigation Research Agreement (CIRA) Post Market – to be used when a medical device company is sponsoring a post market medical device study

• Contract Research Organisation (CRO): MTAA Standard Clinical Investigation Research Agreement (CIRA) for Contract Research Organisations acting as the Local Sponsor – to be used when a contract research organisation is sponsoring a clinical trial on behalf of an international sponsor

• Contract Research Organisation (CRO) post market: MTAA Standard Clinical Investigation Research Agreement (CIRA) Post Market for Contract Research Organisations acting as the Local Sponsor – to be used when a contract research organisation is sponsoring a clinical trial on behalf of an international sponsor

Multi-Jurisdictional Multi-Party non-Clinical Trial Collaborative Research Agreement

A Multi-Jurisdictional Multi-Party Non-Clinical Trial Collaborative Research Agreement can be used where two or more parties collaborating on a research project that is not a clinical trial. Please contact the Research Governance Officer to discuss whether this agreement is suitable for your study.

Approved Research Agreements

A summary of the above approved research agreements for use in NSW Health organisations are in the table below:

Special Conditions Clauses

NSW Health and representatives from other Australian jurisdictions’ health agencies regularly conduct a joint review of sponsor specific clauses for inclusion in the nominated schedule of the research agreements. This panel is known as the Southern and Eastern Border States (SEBS) Review Panel (the review panel).

The review panel meets monthly to consider amendment requests from sponsors. Closing dates for submissions and the review panel meeting dates are published on the Medicines Australia website.

Sponsor-specific clauses can be included Schedule 7 (for a commercially sponsored CTRA) or Schedule 4 (for a collaborative or cooperative group CTRA) and must be approved by the review panel. A copy of the review panel’s approval must be included with the SSA submission.

Collaborative clinical trials supported by a Grant Funding Agreement

The review 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)