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 an associate researcher in ALL projects undertaken at Western Health.
Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.
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.
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. Ensure all documents being submitted are clearly listed
2. Submit a completed Site Specific Assessment (SSA) Form:
Researchers to leave Research Governance Office and CEO sign off pages blank.
Students/Junior staff who have non/some 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 have a permanent position at Western Health and be responsible for the project management.
3. 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. Projects will not be authorised until payment has been made.
4. If funded, please submit a detailed project budget signed by the Principal Investigator & your department business analyst 5. Complete Statement of Approval Form (downloadable right hand side link) 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 FormPlease see below for the following service departments which have specific requirements for governance authorisation:
6. For all Clinical Trials – submit the following, as applicable (hard copies):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)
Western Health details for e-CTN submission:
Clinical Trial Research Agreement (see left hand side link "Research Agreements" for details process
Medicines Australia Standard Form of Indemnity
7. Submit all trial documents as submitted to the Reviewing HREC, and submit all site-specific documents. Submit as applicable:
8. For Collaborative Research across institutions (research other than clinical trials) – submit a Research Collaboration Agreement.
9. In accordance with the NHMRC 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 regarding the agreements, Research Program Director, Mr Bill Karanatsios; [email protected]; (03) 8395 8073.
10. Investigator Qualifications, CVs, Honorary Appointments and External monitor access
11. Please send all the required documents in the following format: An electronic copy via email to [email protected] and one hard copy (double sided) to:
Applicants must submit both the ethics application via ERM and 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.
Convention: [ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 Protocol v1 01Jan19
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.