Low & Negligible Risk Governance SSA Application Submission

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.

If a Western Health employee is involved in the project they should be listed, at the very least, as an associate researcher and must:

Have expertise in a discipline relevant to the project.
Provide a link between the researchers and Western Health
Provide local knowledge that can facilitate the conduct of the research.
Be updated on the progress and status of the project on a regular basis by the external researchers

Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.

Why are we enforcing this instruction?
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.

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.

QA & LNR Governance Submission Requirements:

Submit a Cover Letter, signed by the Principal Investigator
Submit Site Specific Assessment Form

Complete a LNR SSA/SSA form from Ethics Review Manager (ERM) that is to be generated from the LNR Vic/HREA form.

Statement of Approval Forms
Submit all research project documents as submitted and approved by the Reviewing HREC
Investigator Qualifications - CV, GCP and Honorary Appointments
Other documents, if applicable:

Research Collaboration Agreement
Honorary Researcher Application Form (external researchers only)

Research Governance Fee
Submit your Research Governance Application in hardcopy and electronic

Submission requirements in further detail

	Document	Requirement/Details
1.	Cover Letter	Signed by Principal Investigator
2.	Site Specific Assessment Form	Low & Negligible Risk Projects Complete the LNR SSA/SSA form that is generated from the Ethics Review Manager (ERM). All investigators to sign declaration, Please note: SSAs are generated from the LNR Vic/HREA forms reviewed by the ethics committee. ERM Applicant User Guide - DHHS
3.	Statement of Approval Forms	Provide Statement of Approval Form for each Western Health department whose services will be required to undertake your research.
4.	Approved documents	Submit all research project documents as submitted to the reviewing Human Research Ethics Committee (HREC) e.g.: Final approval letter from reviewing HREC As applicable: LNR Vic/HREA - non original signed copy Victorian Specific Module(VSM) (only required if HREA form completed) - generated on ERM As applicable: Master approved Participant Information and Consent Forms (PICF) Site specific Participant Information and Consent Forms based on Master approved PICFs Site Specific PICFs must include: WH Logo, local governance/site specific version number and date, PI/researchers contact details & WH local governance contacts details for complaints Questionnaires/surveys Data Collection Forms Letters of invitation Advertisements Etc
5.	Investigator Qualifications	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 here.
6.	Research Agreements	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
7.	Research Governance Fee	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 reviewed until payment has been made.
8.	Submission	Both Electronic and Hardcopy submissions must be made. See instructions for both below. Electronic Copy: Applicants must submit both the ethics application via Ethics Review Manager (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 See electronic naming convention document (download on right hand side links) for more details. One Hardcopy: 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.