High Risk Research Governance/Site Specific Assessment Submission

Submitting Site Specific Assessment (SSA)

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 permanent Western Health employee with research experience should be involved in ALL projects undertaken at Western Health.

The nominated Western Health should be listed as the Principal Investigator 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

Staff/students who have little 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.

Submission deadlines & COVID-19
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.

Effective 01 November 2021, 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.

Click here for SSA Governance Submission Process Map

Overview of requirements:

Research Governance Cover Letter and Checklist
Research Governance Application Fee
Site Specific Assessment (SSA) form – to be created on the Ethics Review Manager (ERM) website.
Declaration Signatures to be obtained using the WH Site Specific Declaration Signature Form or digitally signed on ERM SSA form for each investigator.
Statement of Approval declarations from Head of Departments that are impacted by the study using the Statement of approval form or digitally signed on ERM SSA form for each Head of Department
Submit all project documents as submitted and approved by the reviewing HREC

Ensure site specific documents created with WH logo and contacts e.g. PICFs, Advertisements/Flyers, Letters to participants etc.

Investigator Qualifications

All research personnel to provide a CV using the WH CV template with a signed WH Research Code of Conduct (2018). CVs on file are valid for 2 years however, the Office for Research has the right to request for updated CVs at any time.
ICH-GCP Training Certificate, it is mandatory that all Investigators and study coordinators has completed ICH-GCP training. Please provide a certificate of completion; the GCP certificate is valid for 3 years.
Honorary Researcher Appointments for external personnel, if applicable.

If funded study: Please provide a detailed budget signed by the Principal Investigator and/or endorsed by a Business Analyst
If applicable:

Research Agreement (Commercial, Investigator-Initiated or Collaborative studies)

Commercial Trials:

Medicines Australia Standard Form of Indemnity
Medicines Australia Standard Form of Indemnity – HREC Review Only (copy)
Current Insurance Certificate
Use of unapproved drugs or devices:

eClinical Trials Notification (eCTN) to the Therapeutic Goods Administration (TGA)

Submission - two full electronic file submissions via ERM AND email to [email protected] See Submission deadline dates here.

Submission requirement guide in further detail

	Document	Requirements/details
1	Research Governance Cover Letter and Checklist	Complete all relevant sections and ensure all documents being submitted are clearly listed with correct version numbers and dates
2	Research Governance Application 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. All fees must be accompanied with a completed Compliant Tax Invoice.
3	Site Specific Assessment (SSA) Form	SSA Form to be created on the Ethical Review Manager (ERM) website. To finalise the SSA form, please submit form through ERM. You will know the form has been successfully submitted/finalised if a Reference Review code is generated (found on bottom left corner of form) Please list all research personnel involved at WH including Study/Research Coordinators. See the following website for useful guides and tools for ERM: https://www.clinicaltrialsandresearch.vic.gov.au/ethical-review-manager Note common errors - please ensure these are correct before submitting: Investigator details Non WH address provided for WH personnel who may have multiple positions at other health services/organisations. Researchers should provide the address the personnel can be found at WH sites. Email address – personal email addresses not linked to Western Health or an organisation e.g. Gmail, Hotmail, Yahoo addresses. It is preferred that the WH email address for the WH personnel to be used or an email address that is linked with another organisation. Role in Project, researchers have often just stated the position of the research personnel e.g. "Principal Investigator" or "Associate Investigator" which is incorrect. This section requires further clarification regarding their duties within the project for example; Consent, data collection, ethics & governance submissions, interviews, blood collection etc. you may also wish to state the position as well for further clarification. CVs and GCP certificates not uploaded onto ERM form Site involvement 3.3 All departments listed in this section must also provide a Head of Department/Supporting Department signature. Data Source and storage at this site (4.2 & 4.2a) Please be familiar with the WH Data Management in Research guideline. Clearly clarify the method of disposal and when this will be disposed Ensure both physical and electronic data care secure, protected and managed according to the WH Data Management in Research Guideline. Supporting documents: Uploading of all documents relevant to the study Signatures Not signed by all research personnel involved at WH site – including Study Coordinators and students
4	Investigator Declaration Signatures	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 (updated 2018), 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. Declaration Signatures from Investigators can be provided in two ways: ERM SSA Form Digital Declaration signatures; OR WH Site Specific Declaration Signature Form, feel free to duplicate the form if more fields are required There is no need to provide signatures/declarations on both forms. It is recommended to digitally sign the form on ERM SSA.
5	Statement of Approval Forms	Signature/s from each Head of Department/Head of Supporting Department can be obtained in two ways: ERM SSA Form Digital Declaration signature/s; OR Statement of Approval Form (Wet ink/scan) The following service departments have separate review requirements to the above: Pathology For studies involving the services of the Dorevitch Pathology Service. The pathology process flowchart can be downloaded on the Pathology page (WH staff access only): http://inside.wh.org.au/departmentsandservices/Pathology/Pages/Research-Requirements.aspx For queries and submission to: [email protected] Please provide signed Pathology Research Approval Form to the Office for Research, this form replaces the Statement of Approval Form for Pathology and a separate signed Statement of Approval for Pathology is not required. Medical Imaging Please email [email protected] for submit the Clinical Trial Application Form and for any queries Above Standard of Care Western Health Medical Imaging Clinical Trial Application Form to be fully signed and completed by the Principal Investigator and Director of Radiology and submit to the Office for Research with signatures. Standard of Care Signed Statement of Approval Form by the Principal Investigator and Director of Radiology Pharmacy The Pharmacy Department will issue a Statement of Approval on their own preferred form. Please contact Lei-Ching Yeoh, Clinical Trial Pharmacist; [email protected] Medical Physicist Assessment Please complete the Victorian Medical Physics Risk Assessment Form, send this to the WH Medical Physicist, Leah Biffin; [email protected] for signature and certification. Please forward a copy of the Medical Physicist Report from the Medical Physicist if ionising radiation is above standard of care. Health Information Services If the project involves assessing medical records, please submit a Health Information Service Statement of Approval Form, signed by Health Information Services, Jodie Antoniou; [email protected]. If researchers are collecting information from BOSSNET only, then a Statement of Approval is not required except when researchers are collecting patient data prior to 24 November 2011. Performance Unit For correlated data for organisation analysis, please obtain Statement of Approval from Manager, Performance Unit, Allen Foo [email protected]; (03) 8345 7639
6	Approved Documents	Submit all current approved trial documents as submitted to the Reviewing HREC, and provide site-specific document versions (e.g. PICF, Advertisements, letters to patients etc.). Submit as applicable: Final approval letter and acknowledgements from the reviewing HREC Please ensure that the HREC lists "Western Health" as an approved participating site or any of the following only: Sunshine Hospital Please note that if the site involves Joan Kirner Women's & children's Hospital (JKWCH), the approval must state 'Sunshine Hospital' and not JKWCH Footscray Hospital Williamstown Hospital Sunbury Day Hospital Drug Health Services Hazeldean Transition Care Sunshine Radiation Therapy Care Bacchus Marsh and Melton Regional Hospital Melton Health & Community Services Bacchus Marsh Community Health Centre Grant Lodge Residential Aged Care Human Research Ethics Application (HREA) Form – signed (non-original copy is acceptable) Victorian Specific Module – signed (non-original signed copy is acceptable) or ERM generated Master approved Participant Information and Consent Forms (PICF) Site specific Participant Information and Consent Forms based on Master approved PICFs. See PICF Site Requirements document. Observation studies: WH logo, local governance/site specific version number and date, PI/researchers contact details & WH local governance contacts details for complaints Clinical Trial/Interventional Studies: WH Digital Medical Record Barcode, WH Logo, patient label, local governance/site specific version number and date, PI/researchers contact details & WH local governance contacts details for complaints Research that do not involve patients require the following only: WH logo, local governance/site specific version number and date, PI/researchers contact details & WH local governance contacts details for complaints. Barcode and patient label not required. Investigator's Brochure – submit ELECTRONIC COPY ONLY NO HARDCOPY REQUIRED Any Questionnaires, surveys, letters of invitation, verbal scripts, advertisements, data collection forms, advertisements etc. Ensure any advertisements, letters of invitation have site specific information such as; WH logo/WH approved letterhead & local governance/site specific version number and date.
7	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 Investigators and study coordinators 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. Commercial Sponsored Projects – External Monitors For Commercially Sponsored Clinical Trials only – External monitors are required to complete and sign the Approval to Examine Medical Records Form. Please refer to relevant documents (right hand side) to set up network access and EMR training for external monitors.
8	Budget	If the project is funded, please provide a detailed budget signed and dated by the Principal Investigator an/or endorsed by a Business Analyst
9	Research Agreement	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.
10.	Clinical Trial documentation	Medicines Australia Standard Form of Indemnity 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 - Two (2) original signed copies each of 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 - Two (2) original signed copies each of 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. Medicines Australia Standard Form of Indemnity - HREC Review Only Please also provide a copy of the signed Medicines Australia Standard Form of Indemnity – HREC Review Only. Please ensure that Western Health and the site Principal Investigator have been listed. 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: Detail the type of insurance - Public and Product Liability - or equivalent such as General Liability or Clinical Trials Insurance Include as a named insured the full, legal name of the Australian entity acting as a Sponsor Detail the period of insurance Provide insurance coverage for a minimum of $10million AUD for any one occurrence and in the annual aggregate Not contain an excess/deductible, or self insured retention amount greater than $25,000 AUD for each and every claim or series of claims arising out of one original case Submit a draft eCTN print preview for noting by the Office for Research. eCTN Application I.D. 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 CTN 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. It is requested that the WH 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 CTN clinical trials (i.e. Investigator initiated trials where there is no external sponsor) For WH sponsored trials, it is the institutions' responsibility to lodge the eCTN to the TGA. Researchers must make an appointment with the Office for Research Manager, Bill Karanatsios (03) 8395 8073 [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. Listing of sites: Ensure that the physical location site name is listed and the correct address of where drug/device will be dispensed/used - Please note that the physical location is NOT where the research team office is located: E.g. 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 Western Health 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	Two electronic copies must be submitted to be considered a full submission. See Submission deadline dates here (Effective from 01 November 2021) Electronic Copies: Applicants must submit both the ethics application via: Ethics Review Manager (ERM) and Email [email protected] 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: [First Name][Last Name] WH CV DDMMMYY [First Name][Last Name] GCP DDMMMYY [First Name][Last Name] WH Code DDMMMYY 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. For incomplete submissions; where it is missing any requisite submission elements (as described above) you will be notified via email that your submission is incomplete. We will not provide a report as to what essential elements are missing. For submissions that have ALL the requisite submission elements for us to be able to conduct the governance review, you will receive a valid submission notification email. You will then receive a comprehensive governance review/response within 4 weeks of the initial submission date. Please be aware this timeline may change depending on the volume of submissions at the time. 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.

My Project is authorised/approved, now what?

Once you receive or are close to receiving governance authorisation for your project, you should complete the WH Startup Checklist to check that you are ready to commence your project and that you have set up your study files appropriately to ensure compliance to GCP requirements.

Document	Requirements/details
WH Start-up Checklist	Complete, sign and store checklist in your Investigator/Study Files. This does not need to be submitted to the Office for Research however, will be requested if audited.
WH Investigator File Folder Setup Guide	This is a suggested Investigator File folder set up guide to be used for projects undertaken at WH. It is important that the study Investigator File/s (also known as Trial Master File (TMF), or Study Site Master File) is created to ensure compliance to GCP requirements. Please also refer to our WH GCP SOP No.002 The Trial Master File and Essential Documents.