Research Governance

Please note:

Any patient facing documents that have been approved by the lead HREC as a master require a site-specific version (such as Participant Information Sheet and Consent Form/s) and must align to HNELHD requirements.

Any patient facing documents that have been approved by the lead HREC as a master require a site-specific version (such as Participant Information Sheet and Consent Form/s) and must align to HNELHD requirements.

Resources:

• Site Specific Document requirements
• SSA Roles & Responsibilities - HNELHD
• Clinical Trials Fees
• REGIS FACTSHEET - Submitting a new version of an application after an ineligible notification
• REGIS - Researcher Training Webinars
• VIDEO: CTMS Sharepoint - How to enter "Study" minimum data set
• VIDEO: CTMS Sharepoint - How to enter "Patient" minimum data set

For example, access request review should be used if the project involves one or more of the following activities at the PHO:

• participant recruitment through posters, leaflets, handouts and letter of invitation but not recruitment through direct contact with potential participants or enrolment;
• distribution of surveys and questionnaires through staff of the PHO, but not collation and analysis of responses at that PHO, and;
• access to data or tissue held at the PHO, but not processing or analysis at that PHO.

Only one form is required for HNELHD; it is not necessary to complete a form for each individual facility, location or service within HNELHD, however written confirmation of support from each HNE facility, locations or services through which you are seeking access to participants, tissue or data is required to be submitted with your access request.

The Research Governance Officer has the discretion to request that the application is submitted for site specific assessment if they consider that the project involves the conduct of research at a site.

You can find the Access Request form here (DOCX 68.47KB).

Please forward the completed application form along with the below (1-4) to the HNE Research Governance Office via: HNELHD-ResearchOffice@health.nsw.gov.au

1. a copy of the HREC letter of approval;
2. a copy of the Human Research Ethics Application (HREA) form;
3. all documents to be distributed through the facilities, locations or services within the PHO; and
4. written confirmation of support from staff of the facilities, locations or services through which you are seeking access to participants, tissue or data*

(*) Written confirmation of support can be received from:

• head of department/manager who agreed to distribute questionnaires or surveys to staff by e-mail; and
• head of department or data custodian who agreed to provide access to medical records, data or tissue held in collections or databases under their management, in line with ethical conditions imposed by the approving HREC

Please note:

• Within HNELHD letters of support from site staff members will not be accepted
• Letters of support will only be accepted from site Head of Department, Site Manager or Data Custodian. Applications submitted without the correct HNELHD letter of support will not be accepted
• Please allow a minimum of 14 days for access request to be reviewed and processed

All patient facing documents intended for use at Hunter New England LHD (District) sites must be made into a site-specific document.

A site-specific document is a copy of the Human Research Ethics Committee (Committee) approved master document and includes information that is specific to the site where the research is to be conducted.

All site documents must:

1. have the right site logo
2. have the local Hunter New England Research Office complaint details
3. have the local Principal Investigator contact details
4. be named as per the Committee approval.
5. include site version and master version in the footer. You can do this in 2 ways:
   • Option 1: Site-specific PICF version number and date (DD/MM/YYYY) (Based on Master Version X, dated DD/MM/YYYY)
   • Option 2: Master document name - Version number and date (DD/MM/YYYY) - Site name - Document name - Version number and date (DD/MM/YYYY)

Please remember:

• If recruitment involves different participant groups, clearly label and prepare an information sheet for each group.
• The document name, information in the footer and filename should all match.
• If documents listed on the Committee approval letter are NOT intended for use within our District, please advise the Hunter New England Research Office with a cover letter along with your SSA submission in REGIS.
• If you are not sure if you need site-specific documentation, email HNELHD-ResearchOffice@health.nsw.gov.au

The Principal Investigator / Supervisor is responsible for completing and submitting all documents relating to the set-up of the external researcher contingent worker.

Before this process can be initiated, the below must have occurred:

1. Governance Authorisation via Site Specific Application
2. External researcher named on the initial Site Specific Application or added as a site investigator via a site amendment in REGIS

Please follow the below steps for this process:

These appointments will formalise existing relationships and facilitate the access of non-clinical and clinical researchers from HNE partner organisations to HNE’s research active clinicians, clinical departments, services. This initiative will support collaboration and transfer of ideas between the non-clinical and clinical care sectors and supports HNE’s program of excellence – every patient, every time.

Click here for ZIP file of all documents

Fee Schedule for Research Ethics Review from 1 July 2025

Fee Schedule for Research Governance Review from 1 July 2025

¹ Refer to Section 4.5 Non-Standard Contracts in the NSW Health Policy Directive Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research (PD2025_017)

Amendments: An amendment is considered as any change to a research project or an approved application that occurs after ethics approval or governance authorisation, respectively, that requires review by a full committee. Where an amendment is submitted to the Research Office as a single batch of documents containing several items for review, only a single amendment fee may be charged.

The amendment fee applies to:

• Protocol amendment
• Revision of the study design due to safety issues
• Revisions in drug dosage, participant groups and number of study participants
• Investigator brochure updates, where there are associated changes required to the Participant Information Sheet/Consent Form (PISCF)

Examples of amendments that do not require review by a full committee and do not attract a fee include:

• Participant Information Sheet/Consent Form amendments with changes not required to be reviewed by the Human Research Ethics Committee
• Investigator brochure updates where there is no change required to the Participant Information Sheet/Consent Form
• Change of Principal Investigator/Coordinating Principal Investigator
• Minor updates to existing patient-facing documents, protocol clarification letters, advertising material and single-word changes

Addition of Sub-study: A sub-study is a study performed a subgroup of the subjects included in the clinical trial. For example: a pharmacokinetics or pharmacogenetics sub-study may include a sample of the patients participating in the clinical trial. A fee for a sub-study will be charged when an already-approved clinical trial submits for approval a study related to the original clinical trial.

Clinical Trial: A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes. Examples of interventions in Clinical trials are: : surgical and medical treatments and procedures; experimental drugs; biological products; medical devices.

Clinical Trial Management System (CTMS): The Clinical Trial Management System (CTMS) is an online repository and management portal for clinical trials carried out by NSW public health organisations. The electronic infrastructure of the CTMS is designed to assist the state’s clinical trials sector and clinical trial units through reduced administrative burden, increased visibility of clinical trial activity, and improved financial management.

Non-Standard Contract: The NSW Health PD2023_017 sets out a series of standard contracts approved for use with both commercial and non-commercial clinical trials. Use of these contracts will not attract a non-standard contract fee. Should a non-standard contract be used by either a commercial or non-commercial sponsor, a non-standard contract fee will be charged.

Commercial External Sponsor:  A commercial entity which is the sponsor of a clinical trial. For the purpose of PD2025_017 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, such entities include all pharmaceutical and medical device companies.

Non-Commercial External Sponsor: A non-commercial entity external to NSW Health which is the Sponsor of a Clinical Trial. For the purposes of PD2025_017 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, such entities include independent medical research institutes, collaborative or cooperative research groups and universities.

Institution Sponsor: A NSW Health Organisation which is the sponsor of a clinical trial. For the purposes of PD2025_017 Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research, such entities include those public health organisations from other Australian jurisdictions as well as other government agencies and departments.

Please submit a site general amendment in REGIS for:

• changes to the study protocol, including the conduct and / or design of the study
• changes to any other study documentation (e.g. consent and recruitment material, study tools)
• site specific versions of approved masters need to be uploaded for all amended patient facing documents

If approving HREC is internal to NSW, the HREC approval and approved documents are not required to be uploaded as they will flow through the REGIS system, you will still need to upload all other site specific documents.

If approving HREC is external to NSW, the HREC approval and all approved documents need to be uploaded to REGIS, along with all other site specific documents.

Please submit a site change to personnel amendment for:

• changing site investigators
• changing administration contact
• for HREC external to NSW - change to CPI/PI and upload HREC approval and CV

Please note: HREC internal to NSW for Change to CPI / PI - the NSW HREC automatically updates REGIS, and no additional site amendment is required.

Please ensure a current Good Clinical Practice Certificate (GCP) is provided if you are adding internal OR external team members for study type: clinical trial and clinical research.

Please ensure you nominate all external researchers that are coming on site or that will be accessing identifiable patient data or HNE clinical systems within the Study Team and review HNE Site and eMR access for external researchers

Please submit all contract amendments via site amendment contract changes in REGIS.

Please ensure both CRG and HNE PI have signed the contract amendment prior to submission.

Electronic Signatures - Click here for further information

Please contact HNELHD-ResearchOffice@health.nsw.gov.au with any queries.

Helpful Resources:

• HNE Institution Details
• Research Governance Regulatory Documents

Please submit site amendment request for an extension of HREC only if approving HREC is external to NSW

• Expiry date is automatically updated once request has been approved by ethics

Please note: HREC internal to NSW for extension of HREC - the NSW HREC automatically updates expiry date in REGIS, and no additional site amendment is required

• REGIS quick reference guide - Site Amendment - Completing & Submitting

Responsibility

• The site Principal Investigator (PI) must stop all project activity at the Hunter New England site until the correct site authorisation has been received.
• The project Coordinating Principal Investigator (CPI) can help the site PI to complete the CAPA. This task can be assigned to a trained individual; however, the site PI and project CPI must manage the whole CAPA process.
• The site PI and project CPI set up and change processes after investigating the root causes of the breach. They also must make sure the right site authorisation is received before restarting research at the Hunter New England site.
• The Hunter New England Research Governance team oversee the CAPA and ensuring the approving Human Research Ethics Committee (Committee) receive notice of the breach.
• The approving HREC Committee reviews the CAPA at its next meeting and decides on the use of existing data or samples collected before the breach.

1. Report the breach as accurately and completely as possible, including:
   • who was involved
   • what happened
   • where the event happened
   • how it happened and why.
2. Recount the project's progress when the breach was found, including:
   • a detailed description of the research at the site.
   • data or samples collected.
3. Describe the immediate action taken after finding the breach. This will help reassure the Research Governance team and approving committee that research was stopped the moment the breach was found.
4. Use the Root Cause Analysis (RCA) method to find system failures that were not clear during the first review. You can find incident management resources, including an RCA toolkit on the Clinical Excellence Commission website.
5. Present actions that address the root cause and provide long-term solutions, including:
   • staff training
   • work process modifications
   • review of workplace procedures
   • reviewing resource allocations or requirements
   • retraining the specific investigator site to receive the right authorisation before research starts on site.

The site PI or Delegate will track the completion of required actions and assess if the implemented actions have addressed the issues.

• The site PI, site Head of Department and project CPI must sign the completed CAPA and then email it to HNELHD-ResearchOffice@health.nsw.gov.au
• The site PI must save or store the completed CAPA documentation in the specified Investigator Site file.
• If the CAPA is not accepted, the site PI must respond within the given timelines.
• After acknowledging the CAPA, Hunter New England Research Governance and the Committee will return it to the site PI or project CPI.
• The HNE site must receive the right site authorisation before restarting the project

In line with recommendations from the Medicines Australia Joint Position Statement, the HNE Research Office accepts electronic signature platforms by way of executing research agreements and other research related regulatory documents. Adobe certified signature and wet signatures are still available.

All documents submitted to HNELHD Research Office via Electronic Signing Platforms must comply with the Submission Procedure stated in the Standard Operating Procedure (SOP) below:

- SOP: Using Electronic Signing Platforms

It is the responsibility of the requester (sponsor / research team) to follow the steps in order to successfully request a document signed by the HNELHD CE Delegate (for Research).

If you have different requirements for your electronic signature platform, please email HNELHD-ResearchOffice@health.nsw.gov.au

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:

• propose use of the standard HNE approved CDA template
• please ensure the correct HNELHD Institution Details are included.

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.

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.

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 Attention:  RGO - CRG agreement for review.

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.

• Multi-Jurisdictional Multi-Party non-Clinical Trial Collaborative Research Agreement - PDF 298 KB

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 (Kristy Morris, Research Governance Manager).

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

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.

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. For more information, see NSW Health Policy Directive - Clinical Trials – Insurance and Indemnity PD2011_006, section 2.2.

• Form of Indemnity - Standard form is to be submitted for all "Commercially" sponsored clinical trials 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 (AUD); 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

For HNELHD sponsored clinical trials, with external sites, a copy of the HNELHD Certificate of Currency can be requested by completing this form, and sending to the Research Office HNELHD-ResearchOffice@health.nsw.gov.au for HNE Research Delegate signature along with a copy of both ethics and governance approvals. The Research Office will then forward the request to HNELHD-InsurableRisk@health.nsw.gov.au who will issue a copy of the Certification of Currency.

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/

The following information is provided to assist with the registration of clinical trials that have been reviewed by the Hunter New England Human Research Ethics Committee (HREC).

The following information is provided to assist identify the circumstances where HNELHD should act as a sponsor:

• Where the organisation co-ordinating the trial is an overseas entity, for example the Children’s Oncology Group trials.
• Where an investigator led study within NSW Health requires the Local Health District to act as the study sponsor on their behalf.
• Where a HNELHD staff member is the Investigator but cannot take on the role of the Sponsor – for example if a clinical trial agreement is required because a pharmaceutical company is providing the trial medication and is requesting access to the study data in return.

CTN lodgement to the TGA will occur by the HNE Research office for all HNELHD Investigator initiated projects or HNELHD sponsored trials.

For this to occur, you will need to draft the CTN submission in the TGA portal and let the Research Office know when the draft is complete (HNELHD-ResearchOffice@health.nsw.gov.au). If you do not have access to the TGA portal, please contact the Research Office to arrange this.

All CTN applications/amendment submissions will incur a fee by the TGA. The Research Office will pay this fee and seek reimbursement of funds from the Principal Investigator (PI).

Key Documents to review before SSA submission:

• Steps for decentralised trials with both primary and satellite site within HNELHD (PDF 238.94KB) (PDF 238.94KB)
• Action table - Primary and satellite sites within HNELHD  (PDF 200.53KB) (PDF 200.53KB)

Summary of Requirements when submitting the SSA:

• Sponsor Approval/Support letters/email to conduct the trial as a teletrial*
• HREC approval for decentralised trials model and listing the HNE sites on HREC approval (both primary and satellite)*
• Supervision plan, delegation logs, IP handling SOP of teletrial/decentralised trial*
• CTRA in name of HNELHD (Schedule 1 & 2include both HNE sites)
• Indemnity (in the name of HNELHD)
• Copy of CTN submission listing Primary Site (and the satellite site if the satellite site handles or manages IP)

* additional requirements for Decentralised trials

For studies involving a HNELHD site and another NSW LHD(s).

Key Document to review before SSA submission:

• Action table - Teletrials outside HNELHD - Site requirements (PDF 201.9KB) (PDF 201.9KB)

Summary of Requirements when submitting the SSA:

• Sponsor Approval/Support letters/email to conduct the trial as a teletrial*
• HREC approval for decentralised trials model and listing the HNE site on HREC approval (as either primary or satellite)*
• Supervision plan, delegation logs, IP handling SOP of teletrial/decentralised trial*
• Copy of CTN submission listing HNE site if HNE will be handling or managing IP
• CTRA between primary site and sponsor
• CTRA subcontract between sites

*additional requirements for Decentralised trials

For queries or support with teletrial setup, please contact HNELHD Research Governance Manager: HNELHD-ResearchOffice@health.nsw.gov.au

HNELHD would like to thank MNCLHD for sharing the decentralised trials templates