Research Governance applications can be reviewed and approved at any time and are not required to be submitted on the HREC submission deadline day. However, early completion and submission of both HREC and Research Governance will ensure faster approval and earlier commencement of your project.

All current documents approved by the HREC and relevant to the implementation of the project at Northern Health, including the HREC approval letters will need to be submitted as part of the research governance application.

Note: Campuses within  Northern Health will be covered under a ‘site’ application; eg: Research to be conducted at Craigieburn Health Service and Bundoora Extended Care will only require one ‘site’ application.

Steps to complete a Research governance application
(Site specific Application or SSA)

1. Download and complete the Research Governance Checklist & Cover Letter

The Research Governance Checklist & Cover Letter is a useful tool for researchers who are not familiar with the research governance submission process.

To download a copy of the Research Governance Checklist & Cover Letter, click here

2. Prepare the Site Specific Application form for submission to Northern Health – Mandatory

Complete a Site Specific Application (SSA) form in ERM. Once all site specific details have been completed and site specific documents uploaded, submit the SSA to Northern Health and email an electronic copy of all documents submitted to ethics@nh.org.au.

Multi site projects – the lead site (if NH is not the lead site)  will need to create and share a SSA within the ‘ERM’  system. Prepare site specific documents on NH template forms e.g. NH letter head, NH PICF template, add NH logo to brochures and upload them to the SSA.

Single site projects – a SSA will need to be generated from the HREC submission within the ‘ERM’  system. If a single site project the master copies may be NH template forms e.g. NH letter head, NH PICF template,  NH logo on brochures.

To download a copy of the Northern Health PICF template for submission via National Mutual Acceptance scheme, click here.
To download a copy of the Northern Health PICF template for submission Austin Health HREC, click here

Tip – add page numbers and version numbers including dates to all document’s. If a master version was used then reference the master version as well as the NH version in the footer of the documents.

NHORE will accept electronic signatures on SSA applications (electronic signatures need to be obtained prior to submission to be valid). For high risk projects, Divisional Directors will have to sign the application in addition to all Department Managers who are required to support the project. For low risk projects, department managers involved in the supporting of the project will be required to authorise the project. Paper authorisation forms can be generated after submission if written signatures need to be obtained. Email copies of authorisation pages to ethics@nh.org.au

Any questions, queries, or assistance regarding submissions contact ethics@nh.org.au

3. For research studies involving ionising radiation procedures

Approval Process for Research Projects Involving Ionising Radiation – Flow Chart

If you have any questions regarding obtain the correct radiation license number, please contact ethics@nh.or.au

To download a copy of the ‘Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information’ form

4. Project Finance – Mandatory

All projects must have a detailed budget submitted as part of the research governance application (HREA SSA page 7, LNR VIC SSA  page 8), either in an agreement/contract between Northern Health and an external Sponsor/Collaborator. For Investigator Initiated trials and internal projects, the budget template must be completed and signed by the Head of Department where the project is being conducted.

To download a copy of the Northern health budget template, click here.

5. Research Agreements – If required

Research agreements are required when the Sponsor is external to Northern Health and should be coordinated by the Northern Health contact person or Principal Investigator.

Research agreements are not required to be submitted as part of an ethics submission, however are required as part of the Northern health governance submission.

Details for Northern Health contracts:
Northern Health
185 Cooper St, Epping VIC 3076
ABN: 42 986 169 981

Click here for further detail regarding research contracts and agreements or contact ethics@nh.org.au if questions or concerns.

6. Prepare Curriculum Vitae (CV) for the research team – Mandatory

A 2 page CV (signed and dated within 2 years) for the Coordinating Principal Investigator, Principal and Associate investigator and research team at NH.

This is required if you are a new researcher or have not submitted a NH CV for more than 2 years for our files.

Researchers may wish to use the NH CV template.
To download a copy of the Northern Health CV template, click here

7.Good Clinical Practice Certification (GCP) – If required

It is a requirement for all NH Coordinating Principal Investigators / Principal Investigators are required to submit a current Good Clinical Practice (GCP) certificate as part of the application.

The minimum standard of GCP training accepted by NH is defined by TransCelerate Biopharma Inc.
Investigators who also work at other institutions should contact the relevant department to determine if they can access TransCelerate accredited GCP training at a more competitive rate.

Click here for further information on TransCelerate accredited GCP training providers.
Contact ethics@nh.org.au for further enquiries.

8. Complete the New Governance Application Fee Form 

Applications will be marked as ‘invalid’ if proof of payment or a Governance Fee Form is not included in the application.
click here for a new application governance fee form

9. Submit an Electronic Copy of All Documents via Email

Ensure all documents are submitted via ERM AND send one electronic copy of all documents submitted as part of the application via email to: ethics@nh.org.au

10. Lodging the Clinical Trial Notification Form

The Sponsor is responsible for lodging a CTN. Where Northern Health is the Sponsor; the CTN must be lodged via the Northern Health Clinical Research Manager.  Email nh.research@nh.org.au to organise an appointment to go over the application. CTN applications are lodged to the TGA online, there is a cost associated with lodgement that will need to be paid at the time of lodgement.

A copy of the Therapeutics Goods Australia CTN Acknowledgment form must be sent to ethics@nh.org.au as part of Research Governance approval conditions.

For all clinical trials – as applicable

  • Submit a draft CTN Landscape preview for noting as a part of NH governance submission.
  • Once TGA acknowledgement has been received, the TGA Acknowledgement and a PDF copy of the lodged CTN must then be forwarded to ethics@nh.org.au as soon as possible for governance acknowledgement.