Research Governance applications can be submitted and reviewed at any time and are not required to be submitted in line with HREC submission deadlines.
Governance applications can be submitted concurrently with HREC submissions, allowing RDGU to commence review – this can speed authorisation timelines. However, please note that since HREC approval is a requirement for governance authorisation, we cannot provide governance authorisation prior to HREC approval.
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)
Step 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.
Step 2. Prepare the Site-Specific Application form for submission to Northern Health
Complete a Site-Specific Application (SSA) form in ERM. Once all site-specific details have been completed, uploaded and submitted in ERM, email ResearchDGU@nh.org.au to notify of your submission.
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.
Visit Library of Forms for further information.
NH RDGU 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 ResearchDGU@nh.org.au
Step 3. For research studies involving ionising radiation procedures
Approval Process for Research Projects Involving Ionising Radiation – Flow Chart
To download a copy of the ‘Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information’ form – please visit the Library of Forms
Step 4. Project Finance
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.
To download a copy of the Northern health budget template, visit the Library of Forms.
Step 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
Follow this link for further detail regarding research contracts and agreements or contact ResearchDGU@nh.org.au if you have any questions or concerns.
Step 6. Details of the research team
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 housed in the Library of Forms.
Step 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.
Click here for further information.
Step 8. Complete the Governance Application Fee Form- if required
A fee is charged for governance review of the following types of research projects:
- Commercially Sponsored studies
- Collaborative Group studies
Fees will no longer be charged for these study types:
- Investigator Initiated
- Registries, Biobanks or Observational Studies
For these project types, applications will be marked as ‘invalid’ if proof of payment or a Governance Fee Form is not included in the governance application.
The fee form can be accessed via Library of Forms
Step 9. Lodging the Clinical Trial Notification Form- if required
The Sponsor is responsible for lodging a CTN. 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.
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 ResearchDGU@nh.org.au as soon as possible for governance acknowledgement.
Please note: Northern Health Site Contact Details to be included in the CTN:
| Name of Approving Authority | Northern Health |
| Approving Authority Contact Officer | Wanda Stelmach |
| Position | Chief Medical Officer |
| Contact Phone | 03 8468 0743 |
| Contact Email | ResearchDGU@nh.org.au |
Step 10. Submit on ERM and notify RDGU
Once all documentation has been submitted on ERM, applicants must notify ResearchDGU@nh.org.au to trigger governance review of the research project.
