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.
The Online Forms site transitioned to a new system called ERM (Ethics Review Manager) in Queensland and Victoria.
Research applications (researchers, trial coordinator, sponsors etc.) can access ERM at https://au.forms.ethicalreviewmanager.com.
ERM is a paperless information management system for completion, submission and storage of documentation for:
Information is available here. For ERM technical assistance, email Infonetica Helpdesk ([email protected]).
Brief overview of requirements for submitting research projects conducted at or by Western Health
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.
Ensure there is no DRAFT watermark on form.
Note: A SSA form must be generated after you have generated a NEAF application form for a project from the https://www.ethicsform.org/au website only.
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 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. Submit a project budget signed by the Principal Investigator. 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. Submit your research governance/site-specific assessment Application. ONE hardcopy plus ONE complete electronic copy to: