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Submitting a Site-Specific Assessment (SSA) application

A step-by-step guide on what's required before starting your higher research project at Western Health.
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Overview

A Site-Specific Assessment (SSA) is a key part of research governance. It ensures your project is suitable, safe and properly supported at any Western Health site.  

Before starting your project at Western Health, you must submit an SSA application and receive research governance authorisation from the Office for Research. This is a review process in addition to obtaining ethics approval for the project at Western Health.   

Involving a WH investigator or student researchers 

All research projects must have a suitably qualified Western Health employee with the relevant research experience nominated as the Principal Investigator (PI) for the project.  

For more information on PIs and eligibility requirements for students, visit our Ethics Review Pathways page. 

 

Submission requirements  

1. Cover letter and checklist 

2. Application fee 

3. SSA form via ERM 

  • Create and submit your SSA form via Ethical Review Manager (ERM).
  • A Review Reference Code will be generated once submitted.
  • Key form requirements:
    • Include appropriate contact details (e.g. Western Health email, not personal Gmail).
    • Clearly describe each researcher’s role and duties regarding the project (e.g. Principal Investigator; consent, data collection, ethics and governance submissions, interviews, blood collection etc).
    • Upload CVs, GCP certificates and relevant supporting documents.
    • Detail data access, storage and disposal (refer to WH Data Management in Research guidelines).
    • All relevant departments must sign off if involved. 

For useful guides and tools on the ERM see the Victorian Government’s Clinical Trials and Research website. 

4. Declaration signatures 

  • Investigators can provide declaration signatures in two ways:

Note: 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 (2025), 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. 

5. Statement of Approval forms 

Note: Some departments have separate review requirements:  

  • Pathology
    • For queries and submissions, email [email protected].
    • Provide signed Pathology Research Approval Form to the Office for Research (replaces the Statement of Approval Form).
  • Medical Imaging
  • Pharmacy
    • Department will issue their own approval form.
    • Please contact Lei-Ching Yeoh, Clinical Trial Pharmacist at [email protected].
    • For all commercial studies, pharmacy fees are non-negotiable and invoiced prospectively.
  • Medical Physical Assessment
    • Please complete the Victorian Medical Physics Risk Assessment form
    • Send to the WH Medical Physicist, Leah Biffin at [email protected].
    • Please forward a copy of the Medical Physical Report from the Medical Physicist if ionising radiation is above standard of care.
  • Health Information Services
    • If the project involves accessing patient medical records prior to 24 November 2011, then you’ll need to submit a Health Information Service Statement of Approval Form, signed by Health Information Services.
    • Email: [email protected].
  • Performance Unit
    • For correlated data for organisation analysis, please obtain Statement of Approval from Manager, Performance Reporting and Analytics, Stuart Dawes.
    • Email: [email protected] or call (03) 9393 0266.  

6. Approved documents 

  • HREC approval letter listing “Western Health” as the entity including any of the following participating Western Health sites e.g. Western Health: Footscray Hospital, Sunshine Hospital and Williamstown Hospital
  • HREA and Victorian Specific Module forms (signed)
  • Master and site-specific PICFs – refer to WH PICF Site Requirements Template
    • Clinical Trial/Interventional Studies: WH Digital Medical Record Barcode, WH logo, patient label, local governance/site-specific version number and date, PI/researcher’s contact details & WH local governance contacts details for complaints
    • All other Clinical or Health Research: WH logo, local governance/site-specific version number and date, PI/researcher’s contact details & WH local governance contacts details for complaints
  • Investigator’s brochure
  • All other supporting documents (e.g. surveys, letters of invitation, verbal scripts, advertisements, data collection forms, etc.)
    • Ensure any advertisements, letters of invitation etc. have site-specific information, such as WH logo/WH approved letterhead and local governance/site-specific version number and date. 

7. Investigator qualifications 

8. Budget 

  • If the project is funded, please provide a signed and dated budget and obtain a WH Business Analyst endorsement where applicable. 

9. Research agreement 

  • Complete relevant standard agreement template (Commercial, Investigator-Initiated or Collaborative studies) and submit to Western Health for review (see Review and Endorsement process).
  • Once endorsed, please provide Western Health’s Office for Research a copy of agreement signed by both sponsor and PI.
  • The Office for Research will then obtain final institutional signatures. 

10. Clinical Trial documentation 

Medicines Australia Indemnity Forms 

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 

  • Drug Trials: Please upload 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: Please upload 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.
  • Please ensure that Western Health and the site Principal Investigator have been listed on the HREC Review only indemnity forms. 
Insurance Certificate 

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:

  1. Detail the type of insurance (Public and Product Liability) or equivalent, such as General Liability or Clinical Trials Insurance.
  2. Include as a Named Insured the full legal name of the Australian entity acting as a sponsor.
  3. Detail the period of insurance.
  4. Provide insurance coverage for a minimum of $10 million AUD for any one occurrence and in the annual aggregate.
  5. Not contain an excess/deductible, or self-insured retention amount greater than $25,000 AUD for each claim or series of claims arising out of one original case. 
Clinical Trial Notification (CTN) 
  • Submit a draft eCTN print preview for noting by the Office for Research.
    • eCTN Application ID 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.
  • For externally initiated sponsored 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.
    • We request that the 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 clinical trials (i.e. Investigator-initiated trials where there is no external sponsor):
    • For WH sponsored trials, it is the institution’s responsibility to lodge the eCTN to the TGA.
    • Researchers must make an appointment with the Office for Research Manager, Bill Karanatsios on (03) 8395 8073 or [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. 
Important: Listing of sites 
  • Ensure that the physical location site name is listed and the correct address of where the drug/device will be dispensed/used.
  • Please note that the physical location is not where the research team office is located, for example:
    • Site Name: Sunshine Hospital 
      Site Physical Location: 176 Furlong Road, St Albans VIC 3021
    • Site Name: Footscray Hospital 
      Site Physical Location: 160 Gordon Street, Footscray VIC 3011 
WH Approving Authority details for e-CTN submission 
  • Name of Approving Authority: Western Health
  • Approving Authority Contact Officer: Mr Bill Karanatsios
  • Position: Research Program Director
  • Contact phone number: 03 8395 8073
  • Contact email address: [email protected] 

11. Submission 

  1. Submit electronically (via ERM).
  2. Send a submission notification email to [email protected]. 
Mandatory electronic file naming format 

To ensure your documents are easily identifiable and meet submission requirements, each file must follow the below naming format: 

[ERM Project ID] [Document Name] [version number] [Date DDMMMYY] 

Example: 

41234 Protocol v1 01Jan19 

For more information, see our Electronic Submission Naming Format guidelines. 

 

What happens after submission 

  1. You’ll receive an auto-reply acknowledging email receipt.
  2. Your submission will be processed (subject to demand) and you will be notified of your review outcome via ERM within 4 weeks.
  • If queries are raised, you have 4 weeks to respond.
  • Delays may result in application withdrawal or rescheduling.
  1. Important: Do not book any Site Initiation Visits before receiving your SSA Authorisation. 

 

Next steps after project authorisation 

  1. Complete the Western Health Startup Checklist
  • This checklist helps confirm that you are ready to start your project and that you have set up your study files appropriately to ensure compliance with GCP requirements.
  1. Set up the Investigator Site File
  1. Amendments and progress reporting

 

Related resources 

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