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Contracts, Agreements, Insurance, Indemnity and Clinical Trial Notifications (CTNs)

When research involves a party external to HNELHD, documentation that relates to the confidentiality, management, insurance, indemnity, financial support and sponsorship may be required.

All clinical trials with an external sponsor must have a written agreement in place, to clarify the obligations, responsibilities and rights of the parties involved in the research. Please be advised that there are several different research agreement templates approved for use within a Public Health Organisation (PHO) that are provided below, the HNE Research Governance team strongly recommend the use of one of these. The use of non-standard agreements will require further review and could result in delays to authorisation. Please refer to the below for guidance regarding the different research agreements approved for use.

HNELHD Delegated Research Authority: The HNELHD Chief Executive Delegate for research authorisation and related contracts/agreements is Professor John Wiggers, Director HNE Population Health and HNE Research Email:  HNELHD-ResearchOffice@health.nsw.gov.au Phone: 02 4921 4140

Please refer to this document for HNELHD Institution Details

Please refer to this document for Electronic Signatures - Click here for further information

Please click the drop-downs below for HNE guidance.

Confidentiality Disclosure Agreements (CDAs)

Maintaining the confidentiality of information is taken very seriously by most commercial and non-commercial research sponsors which is why they often require a non-disclosure agreement or confidentiality agreement before disclosing information such as the study protocol. These agreements are generally legally binding and, if breached, could result in court action.

HNELHD Requirements:

  • It is a HNELHD requirement that all CDAs must be project specific and reference the specific protocol within, HNELHD will not support CDAs that are not protocol specific.
  • All CDAs must have space for 3 signatures, as all HNE CDAs are to be signed by: HNELHD Chief Executive Delegate, in addition to the HNE staff member receiving the information

If you are asked to sign a CDA or NDA:

Submission Instructions;

  • if using the HNE proposed template, please complete the CDA, including seeking signature from the sponsor and proposed HNE PI and submit to HNELHD-ResearchOffice@health.nsw.gov.au for review and to arrange HNELHD CE Delegate signature.
  • for all other CDAs, please email a draft version to HNELHD-ResearchOffice@health.nsw.gov.au for review in the first instance.

Please allow a minimum of 14 days for review of non standard CDAs.

Clinical Trial Research Agreements (CTRAs)

The following Medicines Australia CTRA templates have been approved for use in NSW PHOs

  • 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

The following teletrials subcontract has been designed to complement the Clinical Trial Research Agreement – Medicines Australia Standard Form, which would form the Head Agreement when a study is conducted under a Teletrials model.

  • CTRA subcontract for studies conducted under a Tele-trials model

All Medicines Australia CTRA templates can be located/downloaded here

Please be advised changes cannot be made to the standard clauses (pages 2-17). Any clauses included at Schedule 4 or 7 must be approved by the SEBS Committee and evidence of SEBS approval must be provided with the application.

HNELHD Submission Instructions: 

  • Please ensure the correct HNELHD Institution Details are included.
  • If your agreement includes special conditions, please upload SEBS Committee Approval with your site application.
  • If your agreement includes special conditions without SEBS approval, please forward to HNELHD-ResearchOffice@health.nsw.gov.au for review prior to submitting your site application. Attn RGO; Special conditions on standard contract for review.
  • 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.

For agreements where HNE is CRG, HNE will be required to sign the agreement first. Please email draft agreement to HNELHD-ResearchOffice@health.nsw.gov.au  Attn:  RGO - CRG agreement for review.

Clinical Investigation Research Agreement (device trial)

A device trial is known as a 'clinical investigation' rather than a 'clinical trial'. The Medical Technology Association of Australia (MTAA) has developed a Clinical Investigation Research Agreements (CIRAs) and a Form of Indemnity (FoI) for use in commercially sponsored studies of medical technology. Please click here for further information on regulatory documents for use when conducting device trials including the MTAA Standard Clinical Research Investigation Agreement (CIRA) template.

HNELHD Submission Instructions: 

  • Please ensure the correct HNELHD Institution Details are included.
  • If your agreement includes special conditions, please upload SEBS Committee Approval with your site application.
  • If your agreement includes special conditions without SEBS approval, please forward to HNELHD-ResearchOffice@health.nsw.gov.au for review prior to submitting your site application. Attn RGO; Special conditions on standard contract for review.
  • 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.

For agreements where HNE is CRG, HNE will be required to sign the agreement first. Please email draft agreement to HNELHD-ResearchOffice@health.nsw.gov.au  Attn:  RGO - CRG agreement for review.

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 Research Collaborative Agreement Template

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.

Submission Instructions:

  • 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.

Indemnity

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 External Link 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

Insurance

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. This insurance should cover a minimum amount of $10 million (AUD). 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.

Therapeutic Goods Administration Clinical Trial Notification (CTN)

Therapeutic Goods Administration Clinical Trial Notification (CTN)

The Australian clinical trial sponsor must notify the TGA of the intent to sponsor a clinical trial involving an 'unapproved' therapeutic good prior to commencement of the use. The notification form must be submitted online and accompanied by the relevant fee.

From 1 July 2015, the Therapeutic Goods Administration (TGA) transitioned to an online system for CTN submission. The online CTN form can be accessed via the TGA business services website. For step-by-step instructions on how to obtain access to this TGA form and submit a CTN, see the TGAs CTN form - user guide.

Please click here for HNELHD Information and Guidance to assist with the registration of clinical trials:

  • Reviewed by the Hunter New England Human Research Ethics Committee (HREC); and/or
  • Being conducted in Hunter New England Local Health District facilities.

This document also contains information regarding HNELHD as study Sponsor.

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/