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.
Documents are downloadable on the right hand side.
Please note: A permanent Western Health employee with research experience should be involved in ALL projects undertaken at Western Health.
Staff/students who have little research experience with <2 publications should not be listed as a Principal Investigator (PI), their Supervisor or Senior should be the PI and they should be responsible for the project management.
Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.
Why are we enforcing this instruction?
Receiving a complete application in one package allows that application to be reviewed once, as opposed to multiple times. This promotes efficiency and will allow the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.
Please ensure you are familiar with the WH Standard Operating Procedures - Good Clinical Practice (WH SOP-GCP) for research. The Office for Research may conduct an audit at any time.
SSA Form to be created on the Ethics Review Manager (ERM) website. To finalise the SSA form, please submit form through ERM. You will know the form has been successfully submitted/finalised if a Reference Review code is generated (found on bottom left corner of form)
Please list all research personnel involved at WH including Study/Research Coordinators.
ERM Applicant User Guide - DHHS
Note common errors - please ensure these are correct before submitting:
Declaration Signatures from Investigators can be provided in two ways:
There is no need to provide signatures/declarations on both forms. It is recommended to digitally sign the form on ERM SSA as WH slowly transitions onto the ERM platform.
Complete a separate Statement of Approval Forms for each Western Health department whose services will be required to undertake your research.
The following service departments have separate review requirements:
For studies involving the services of the Dorevitch Pathology Service. The pathology process flowchart can be downloaded on the Pathology page (WH staff access only): http://inside.wh.org.au/departmentsandservices/Pathology/Pages/Research-Requirements.aspx
For queries and submission to: [email protected]
Please provide signed Pathology Research Approval Form to the Office for Research, this form replaces the Statement of Approval Form for Pathology and a separate signed Statement of Approval for Pathology is not required.
Please email [email protected] for submit the Clinical Trial Application Form and for any queries
Above Standard of Care
Western Health Medical Imaging Clinical Trial Application Form to be fully signed and completed by the Principal Investigator and Director of Radiology and submit to the Office for Research with signatures.
Standard of Care
Signed Statement of Approval Form by the Principal Investigator and Director of Radiology
Medical Physicist Assessment
Please complete the Victorian Medical Physics Risk Assessment Form, send this to the WH Medical Physicist, Leah Biffin; [email protected] for signature and certification.
Please forward a copy of the Medical Physicist Report from the Medical Physicist if ionising radiation is above standard of care.
Health Information Services
If the project involves assessing medical records, please submit a Health Information Service Statement of Approval Form, signed by Health Information Services, Bernadette O'Shannassy, Bernadette.O'[email protected]; (03) 8345 6594.
If researchers are collecting information from BOSSNET only, then a Statement of Approval is not required except when researchers are collecting patient data prior to 24 November 2011.
For correlated data for organisation analysis, please obtain Statement of Approval from Manager, Performance Unit, Allen Foo [email protected]; (03) 8345 7639
Submit all current approved trial documents as submitted to the Reviewing HREC, and provide site-specific document versions (e.g. PICF, Advertisements, letters to patients etc.). Submit as applicable:
Curriculum Vitae (CV)
Researchers involved at WH site are required to provide a CV using the Western Health CV template and sign the declaration that they have read and understood the WH Research Code of Conduct (2018). If researchers do not use the WH CV template, please sign and date their preferred full CV and sign and date the declaration located on the last page of the WH Research Code of Conduct (2018).
International Conference on Harmonisation – Good Clinical Practice (GCP)
It is mandatory for the Investigators and study coordinators to have completed GCP training. Please provide a certificate of completion; this must be completed within the last 3 years.
Honorary Researcher Appointment
This is required for any external researchers who may be coming on site and who may have contact with patients, access identifiable data, or using our resources/facilities.
Commercial Sponsored Projects – External Monitors
For Commercially Sponsored Clinical Trials only – External monitors are required to complete and sign the Approval to Examine Medical Records Form. Please refer to relevant documents (right hand side) to set up network access and EMR training for external monitors.
Research Agreement (Commercial, Investigator-Initiated or Collaborative studies) – see requirements and process here for legal review of endorsement of agreements.
Once endorsed, please provide 3 x copies with original wet ink signatures in hardcopy for signing.
Medicines Australia Standard Form of Indemnity
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
Please also provide a copy of the signed Medicines Australia Standard Form of Indemnity – HREC Review Only. (non-original copy is acceptable)
For commercially sponsored clinical trials, submit a copy of the sponsor's certificate of insurance. This should comply with the VMIA minimum requirements for clinical trials insurances:
Clinical Trial Notification
For externally initiated sponsored CTN Clinical Trials (Commercial, a collaborative group or another hospital)
For Western Health sponsored CTN clinical trials (i.e. Investigator initiated trials where there is no external sponsor)
Listing of sites:
Ensure that the physical location site name is listed and the correct address of where drug/device will be dispensed/used.:
E.g.Site Name: Sunshine HospitalSite Physical Location: 176 Furlong Road, St Albans VIC 3021Site Name: Footscray HospitalSite Physical Location: 160 Gordon Street, Footscray VIC 3011
E.g.Site Name: Sunshine HospitalSite Physical Location: 176 Furlong Road, St Albans VIC 3021
Site Name: Footscray HospitalSite Physical Location: 160 Gordon Street, Footscray VIC 3011
Western Health Approving Authority details for e-CTN submission:
One hardcopy AND two electronic copies must be submitted to be considered a full submission.
Applicants must submit both the ethics application via 1)Ethics Review Manager (ERM) and 2) Email [email protected]
Mandatory electronic file name convention:
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.
Projects submitted with documents that do not follow the below naming convention/format will not be considered and will be returned via email to sender.
Please do not use the following symbols in your electronic filename: ! @ $ % & ?
Convention: [ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 Protocol v1 01Jan19
CVs, GCP & Codes (where applicable) to be named as:
See electronic naming convention document (download on right hand side links under 'Information and Guides') for more details.
By post/drop-off: Manager Office for Research Level 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.