Submitting Site Specific Assessment (SSA)
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.
Note: During these times of resource constraints, the Office for Research is unable to review submissions that are incomplete. Submissions which are found upon preliminary review to be incomplete will not be further reviewed and a notification stating that the submission is incomplete will be issued if requisite submission elements are missing. It will be the responsibility of the submitter to ensure that the re-submission is completed in accordance with the requirements of the Office for Research. We therefore strongly encourage all staff to familiarise themselves with the submission requirements and ensure that a complete submission is made to the Office for Research to avoid review delays. It is anticipated that incomplete submissions will result in governance review delays.
No submission deadlines for COVID-19 studies and Commercially Sponsored trials/projects, these can be submitted at any time but above review conditions for incomplete submissions will apply.
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 Ethical 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.
See the following website for useful guides and tools for ERM: https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager
Note common errors - please ensure these are correct before submitting:
Data Source and storage at this site (4.2 & 4.2a)
In submitting the site specific research governance application and signing the Declarations section of the SSA Form/WH Site Specific Declaration Form, the Principal Investigator, other investigators and the relevant approving Head of Department(s), each confirm and acknowledge their respective responsibilities to comply with the National Statement on Ethical Conduct in Research (updated 2018), Australian Code for the Responsible Conduct of Research (2018), including all associated guidelines and the Western Health suite of research policies, guidelines and standard operating procedures.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.
Signature/s from each Head of Department/Head of Supporting Department can be obtained in two ways:
The following service departments have separate review requirements to the above:
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
The Pharmacy Department will issue a Statement of Approval on their own preferred form. Please contact Lei-Ching Yeoh, Clinical Trial Pharmacist; [email protected]
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, Jodie Antoniou; [email protected].
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:
Please note that if the site involves Joan Kirner Women's & children's Hospital (JKWCH), the approval must state 'Sunshine Hospital' and not JKWCH
Footscray HospitalWilliamstown HospitalSunbury Day HospitalDrug Health ServicesHazeldean Transition CareSunshine Radiation Therapy CareBacchus Marsh and Melton Regional HospitalMelton Health & Community ServicesBacchus Marsh Community Health CentreGrant Lodge Residential Aged Care
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
Medicines Australia Standard Form of Indemnity - HREC Review Only
Please also provide a copy of the signed Medicines Australia Standard Form of Indemnity – HREC Review Only. Please ensure that Western Health and the site Principal Investigator have been listed.
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 - Please note that the physical location is NOT where the research team office is located:
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:
Two electronic copies must be submitted to be considered a full submission.
See Submission deadline dates here (Effective from 01 November 2021)Electronic Copies:
Applicants must submit both the ethics application via:
NO hardcopies are currently required due to COVID-19 contingencies.
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.
What to expect from the Office for Research after you submit:
You will receive a generic automatic reply indicating the submission email has been received by the Office for Research.
Your application will be checked to determine that ALL the requisite submission elements have been included.
What you must do:
For complete (valid) submissions that have been reviewed and comments provided, you will be given 4 weeks to respond.
Failure to respond or address queries within this timeframe will result in your governance application being put on hold and to be reviewed at the next available date.
The next available date will be determined by the number of complete (valid) submissions that need to be processed at that time of your resubmission.
Incomplete submissions and failure to address requirements within the required response times may be withdrawn and a new resubmission and fee may be imposed.
Please Note: Site Initiation Visit meetings should not be booked prior to governance review.
Once you receive or are close to receiving governance authorisation for your project, you should complete the WH Startup Checklist to check that you are ready to commence your project and that you have set up your study files appropriately to ensure compliance to GCP requirements.
Please also refer to our WH GCP SOP No.002 The Trial Master File and Essential Documents.