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 Western Health employee should be nominated as a contact person as a principal researcher in ALL projects undertaken at Western Health.
Due to the impact of COVID-19 on the organisation, staff and the need to change governance administration processes, we provide the below governance submission changes to help ensure that research is processed in an expeditious and efficient manner, particular if resources are further impacted.
In order to help the Office for Research better manage the workload that is coming through, all non Covid-19 related research and Investigator-Initiated research will be subject to the below governance submission deadlines.
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.
Low & Negligible Risk Projects
Complete the LNR SSA/SSA form that is generated from the Ethics Review Manager (ERM). All investigators are to sign individual declarations in ERM.
Please note: SSAs are generated from the LNR Vic/HREA forms reviewed by the ethics committee.
ERM Applicant User Guide - DHHS
Note common errors - please ensure these are correct before submitting:
Signature/s from each Head of Department/Head of Supporting Department can be obtained in two ways:
Submit all current approved trial documents as submitted to the Reviewing HREC e.g.:
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 Principal Investigator 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. Please see Honorary Researcher Appointment process.
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.
Please contact Bill Karanatsios for any queries. [email protected]; 03 8395 8073
Two electronic copies must be submitted to be considered a full submission.
See Submission deadline dates here (Effective from 01 November 2021)
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.