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Clinical Trials & non-Clinical Trial Collaborative Research AgreementsBackground 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:
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
Name of Institution: Sydney Local Health District 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.
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:
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:
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