All high risk projects and all projects reviewed under the multi-centre research umbrella are required to submit a Research Governance application/Site Specific Assessment (SSA) to the Office for Research.
Western Health is an accepting site under the Streamlined Ethical Review Process (SERP) coordinated by the Department of Health.
Site-Specific Assessment (SSA) is a key element of research governance.
Once an ethics submission has been made to the reviewing HREC, researchers MUST also submit a Research Governance/SSA Application to WH for Governance review and site authorisation before commencing the project even if ethics approval has been given.
Please note: A Western Health employee should be nominated as a contact person or an associate researcher in ALL projects undertaken at Western Health.
Complete the Research Governance Cover Letter & Checklist
Submit a Site-Specific Assessment (SSA) form (Generate form on Online Forms website)
Pay the Research Governance Review Fee
Submit a project budget signed by the Principal Investigator
Complete departmental approval forms/Statement Approval Forms
Clinical Trials documentation if required (CTRA, e-CTN, Insurance, Indemnities)
Submit all trial documents as submitted to the Reviewing HREC, and submit all site-specific documents
Research Collaboration Agreement (If applicable)
Material Transfer Agreement (If applicable)
Investigator's Curriculum Vitae
Submit your Research Governance / Site-Specific Assessment Application
The process for HREC Ethics review and SSA Governance submission should be conducted and submitted in parallel. However, SSA authorisation cannot be completed until HREC approval has been received.
1. Complete the Research Governance Cover Letter & Checklist for all Principal Investigators
2. Submit a completed Victorian Site-Specific Assessment (SSA) Form with signatures of all Western Health Researchers, Head of Department and Head of Supporting Departments.
Note: A SSA form must be generated after you have generated a NEAF application form for a project from the https://www.ethicsform.org/au website only.
3. Governance Fees Include the applicable fee for research governance/site-specific assessment. Fees are payable upfront at the time of submission of your Research Governance/Site-Specific Assessment Application. Please see our Governance fee schedule here.
4. Submit a project budget signed by the Principal Investigator(PI)
5. Complete a Statement of Approval Form for each Western Health department whose services will be required to undertake your research. Researchers are advised to provide signed copies. Alternatively, researchers may also choose to use the SSA Head of Department/supporting Department signature pages generated from the SSA Form (Online Forms) which can replace the Statement of Approval Form.
Please see below for the following service departments which have specific requirements for governance authorisation:
Pharmacy – A signed SSA Declaration page/Statement of Approval Form from Pharmacy is mandatory for all studies involving the use of drugs.
Pathology – for studies requiring the services of the Dorevitch Pathology Service. Please see the Pathology Approval Process flowchart.Please complete the following forms and email to "WHS – Research Pathology".
Pathology Request for Quote Form
Pathology Research Approval Form
Schedule of Investigations - Standard of Care FormHaving trouble completing Pathology forms? Please see the following examples of completed Pathology Forms, for any further queries regarding the forms, please email 'WHS - Research Pathology':
Example of Completed Pathology Quote Form
Example of Completed Pathology Approval FormPlease provide signed Pathology Research Approval Form to the Office for Research, this form replaces the SSA/Statement of Approval Form for Pathology and a signed SSA/Statement of Approval for Pathology is not required.
Radiology – A signed SSA Declaration page/Statement of Approval is not required if the Western Health Medical Imaging Clinical Trial Application Form has been fully signed and completed by the Principal Investigator and Director of Radiology (or delegate) and submit to the Office for Research with signatures. The following forms are required:
Medical Imaging Clinical Trial Application Form
Schedule of Investigations - Medical ImagingPlease contact Natasha Bogoevski, PA for the Director of Medical Imaging, for clarification or queries regarding the Clinical Trial Application Form and Schedule of Investigations; [email protected]; 03 83456117. Update: New regulations regarding radiation notifications, presentation here (Presented on 28 Nov 2014 at DoH Forums). also see the Department of Health Consultative Council for Clinical Trials Research website for updates.
Also, complete the forms below as they apply to your research project:
6. For all Clinical Trials - submit the following, as applicable (hard copies):
e-CTN or e-CTX
New Process for submitting CTNS
The process for submitting Clinical Trial Notifications (CTNs) to the Therapeutic Goods Administration(TGA) has changed. WH no longer requires submission of a paper copy CTN at the time of ethics or governance application.
Sponsors now have the following two options:
Submit pre governance authorisation:
Submit a draft eCTN print preview for noting by the Office for Research. eCTN Application I.D. will be noted in authorisation letter.
Once WH Governance has been authorised, Sponsors are required to lodge form directly to the TGA.
Once TGA Acknowledgement has been received, the TGA Acknowledgement and a PDF copy of the lodged CTN must then be forwarded to the Office for Research [email protected] as soon as possible for acknowledgement.
Submit post governance authorisation:
Sponsors are required to lodge the eCTN form directly to the TGA.
Once TGA Acknowledgement has been received, the TGA Acknowledgement and a PDF copy of the lodged CTN must then be forwarded to the Office for Research [email protected].au as soon as possible for acknowledgement.
For externally initiated sponsored CTN Clinical Trials (Commercial, a collaborative group or another hospital)
It is the external Sponsor's responsibility to lodge the CTN directly with the TGA online. It is requested that the WH Principal Investigator forward this confirmation from the TGA and a PDF copy of the lodged CTN to [email protected] as soon as this is available.
For Western Health sponsored CTN clinical trials (i.e. Investigator initiated trials where there is no external sponsor) For WH sponsored trials, it is the institutions' responsibility to lodge the eCTN to the TGA. Researchers must make an appointment with the Office for Research Manager, Bill Karanatsios 8395 8073 [email protected] to lodge the CTN application online together. The fees associated with the CTN submission will be set against the applicable research department cost centre.
Western Health details for e-CTN submission:
Drug Trials - Two (2) original signed copies each of the Standard Medicines Australia Form of Indemnity for Clinical Trials and a copy of the HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials as applicable.
Device Trials - Two (2) original signed copies each of the Standard Medical Technology Association of Australia Form of Indemnity for Clinical Investigation and a copy of the HREC Review Only Medical Technology Association of Australia Form of Indemnity for Clinical Investigation as applicable.Note: For all indemnities given by sponsors to Western Health, please complete the "To" or ("the Indemnified Party") section on page one as follows: Name: Western Health ABN: 61 166 735 672 Address: 176 Furlong Rd, St Albans VIC 3021
7. Submit all trial documents as submitted to the Reviewing HREC, and submit all site-specific documents Submit as applicable:
Site Specific PICFs must include: WH Digital Medical Record Barcode, Western Health Logo, patient label, local governance/site specific version number and date, Principal Investigators/researchers contact details & Western Health local governance contacts details for complaints.
Western Health Local Governance contact details to be inserted:Name: Mr Bill KaranatsiosPosition: Manager, Western Health Office for ResearchTelephone: 03 8395 8073Email: [email protected]
For Barcode, WH letter head, patient label, version dates and contact details for complaints, please see the WH Site Specific PICF Requirements Template downloadable on right hand side link.
Investigator Brochures ELECTRONIC COPY ONLY, HARDCOPIES NOT REQUIRED
Data Collection Forms
8. For Collaborative Research Across Institutions (research other than clinical trials) - submit a Research Collaboration Agreement.In accordance with the Australian Code for the Responsible Conduct of Research, organisations involved in a joint research project should ensure that agreement is reached with the partners on the management of the research. This agreement should be in writing. Researchers may use the template developed by Western Health for this purpose or may use an agreement developed by a collaborating partner.Please contact the Office for Research 03 8395 8073 regarding this agreement.
9. Complete a material transfer agreement if applicable. Please contact the Office for Research regarding this agreement 03 8395 8073.
10. Investigator's Curriculum Vitae (CV) using Western Health Curriculum Vitae Template (download right hand side links). If Investigator's wish to submit their full CVs, a signed Western Health Researcher's Code of Conduct (2012) Declaration is also required.
11. Submit your research governance/ site-specific assessment application (one hard copy, PLUS one complete e-copy) to:
Submit the hard copy to:
By post/drop-off:ManagerOffice for ResearchLevel 3 Western Health Centre for Health Research & Education – Sunshine Hospital,Furlong Road, St Albans VIC 3021Drop-off/after hours:A drop off box is located in the Ground Level Staircase (right of the elevators) of the Western Health Centre for Health Research & Education Building, Sunshine Hospital, Furlong Road, St Albans VIC 3021. Please note that this box will be checked once a day.
By post/drop-off:ManagerOffice for ResearchLevel 3 Western Health Centre for Health Research & Education – Sunshine Hospital,Furlong Road, St Albans VIC 3021
Drop-off/after hours:A drop off box is located in the Ground Level Staircase (right of the elevators) of the Western Health Centre for Health Research & Education Building, Sunshine Hospital, Furlong Road, St Albans VIC 3021. Please note that this box will be checked once a day.
Submit the e-copy of your research governance/site-specific assessment application to: [email protected]org.au