Multi-Jurisdictional Multi-Party non Clinical Trial Collaborative Research Agreement
The Multi-Jurisdictional Multi-Party non-Clinical Trial Collaborative Research Agreement was endorsed by all jurisdictions at the Clinical Trials Project reference Group meeting held on the 13th April 2022. This follows extensive consultation across the research sector. This template agreement is non mandatory and follows the model of the Medicines Australia and Medical Technology Association of Australia suite of clinical trial research agreements. Please note than any change to any of the clauses shall be made between the contracting parties and their respective legal counsel in Schedule 1. Changes to clauses in this agreement will not be reviewed by the Southern Eastern Border States (SEBS) panel.
This agreement is designed to offer the non-clinical trials research sector the efficiencies realised in Australia when nationally accepted clinical trials contract templates were introduced.
To meet HNELHD Requirements, Signing Page (page 20 of template) should incorporate the acknowledgement of the HNELHD PI, by signing the agreement before submitting via REGIS for HNE authorised officer signature (Prof John Wiggers, Director Research).
HNELHD Research Collaborative Agreement
Please see below HNELHD Research Collaborative Agreement template to be used for research that requires an agreement but doesn't align to the approved Medicines Australia or MTAA Agreements:
HNELHD Submission Instructions:
- Please ensure the correct HNELHD Institution Details are included in your proposed agreement
- Agreements must be signed by the Sponsor and Principal Investigator before submitting with your governance application (SSA) in REGIS, or via REGIS Site Amendment - Contract Changes if submitting a contract amendment.
- Fully executed agreements will be signed and returned with project authorisation or site amendment via REGIS.
Electronic Signatures - Click here for further information
Material Transfer Agreements (MTAs)
If your research involves a transfer of data, materials or samples (such as cell lines, blood, tissue, CT and MRI scans and other clinical data) from HNELHD to an external site and does not require a CTRA or other collaboration agreement a MTA may be required. Please contact the HNE Research Office before submitting your SSA if you are unsure, or require review of a MTA before submitting your SSA.
Non Standard Agreements
The HNE Research Office strongly recommend the use of the standards agreements mentioned above. The use of non-standard agreements will require further review and could result in delays to authorisation.
- Please email the draft agreement (include any supporting documents) to: HNELHD-ResearchOffice@health.nsw.gov.au
- Email subject line: Attn: RGO Non standard Contract for review (add PI surname)
Please allow a minimum of 14 days for first review of all non standard agreements.
For all commercially sponsored clinical trials a Medicines Australia Form of Indemnity must be provided by the commercial sponsor on the Medicines Australia Form of Indemnity for Clinical Trials. The Medical Technology Association of Australia has forms of indemnity available for commercially sponsored clinical investigations.
- Form of Indemnity - Standard form is to be submitted with the governance application (SSA) when HNELHD is providing premises for the conduct of the study, or is providing premises only.
Please find HNE Institution Details here required for Form of Indemnity.
For all commercially sponsored clinical trials, an Insurance Certificate must be submitted with the governance application. The insurance certificate should: Cover a minimum of $20 million (AUS); have an Australian-named sponsor; and an excess/deductible or self-insured retention amount not greater than $25,000 for each and every claim. For more information, see NSW Health Policy Directive - Clinical Trials – Insurance and Indemnity PD2011_006, section 2.2.
For non-commercial external sponsored research, sponsors must provide indemnity or insurance arrangements that are sufficient to cover their sponsor-related liabilities. For more information, see NSW Health Policy Directive - Clinical Trials – Insurance and Indemnity PD2011_006
HNE Research Office is collecting and storing on file certificate insurances from non-commercial sponsors, so that researchers are not repeatedly required to obtain and provide this. Occasionally when a certificate has expired, or the insurance cannot be located in the HNE Research Office file, you may be asked to obtain and provide evidence of insurance.
NSW Civil and Administrative Tribunal (NCAT) approval
If your study requires NSW Civil and Administrative Tribunal (NCAT) approval, please obtain this approval prior to submission. Under Part 5 of the Guardianship Act 1987 (NSW), clinical trials which seek to involve a person aged 16 years or older with decision making disability must be approved by the Guardianship Division of the NSW Civil and Administrative Tribunal (NCAT). Further information: https://ncat.nsw.gov.au/