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.
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 firstname.lastname@example.org.
Multi site projects – the lead site (if NH is not the lead site) will need to create and share an 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 – an 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 the 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 email@example.com
Any questions, queries, or assistance regarding submissions contact firstname.lastname@example.org
3. For research studies involving ionising radiation procedures
If you have any questions regarding obtaining the correct radiation license number, please contact email@example.com
4. Project Finance – Mandatory
All projects must have a detailed budget submitted as part of the research governance application either in an agreement/contract between Northern Health and an external Sponsor/Collaborator or as indicated in the HREA, SSA, and protocol. 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.
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:
185 Cooper St, Epping VIC 3076
ABN: 42 986 169 981
6. Details of the research team – Mandatory
For medical practitioner researchers, the NH local Principal Investigator should be a member of the senior medical staff appointed to Northern Health (either permanent appointed or ongoing honorary).
For nursing, allied health and all other disciplines, the NH local Principal Investigator needs to be a senior staff member.
Please submit a 2 page CV (signed and dated within 2 years) for the Coordinating Principal Investigator, all Principal and Associate investigators 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 firstname.lastname@example.org 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: email@example.com
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 firstname.lastname@example.org 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 email@example.com 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 firstname.lastname@example.org as soon as possible for governance acknowledgement.