Multi-site Greater Than Low Risk Applications

Generate a reference number for your project via the Barwon Health Research Reference Number Generator if you have not already done so.

Please ensure that your Barwon Health reference number is quoted at the time of your submission and included on the cover page of your protocol.

For studies where Barwon Health will formally act as sponsor of a research project, including:

• Barwon Health sponsored clinical trials (CTN/CTX clinical trials within the scope of the Therapeutic Goods Act); and
• All Barwon Health-led multi-site studies

At least six (6) weeks before the intended submission deadline date, please email rdu@barwonhealth.org.au  with a project outline and budget.

RDU will then advise if your project will require presentation at the next Research Management Committee to secure Barwon Health sponsorship.

This process must be completed before a trial/study application can be accepted for ethics and/or governance review.

Regional multi-site project

Please refer to our document naming guidelines before submitting your application.

HREA form – complete via ERM

Must include:

• Protocol, including list of collaborating sites and site PIs – click for template (download)
• Participant Information and Consent Form (PICF) or Plain Language Statement (PLS) if using a survey/questionnaire (download)
• Curriculum Vitae of all members of the research team, including each site PI- click for template
• Peer Review Form (Commercial Clinical Trials exempt) – click for guidelines and pro forma (download)
• Signature from Co-ordinating Principal investigator, if able to sign on behalf of the whole research team
• Fee Payment Form – visit the Research Fees page for detailed information on all ethics and governance fees
• Ethics Checklist – required for Investigator Initiated Clinical Trials

Supplementary documents:

• Supporting documents (surveys, questionnaires, etc) – these can be set up in REDCap for secure electronic data capture
• Waiver of Consent application – please complete the Waiver of Consent Checklist to confirm requirements (downloads)
• Authorship Record Form Template (download) – see Guidelines on Collaborative Research and Authorship
• Details of Data Safety Monitoring Committee – click here to download Data and Safety Monitoring Board Charter template
• For clinical trials involving drug, device or biological
  • Investigator Brochure
  • CTN/CTX – Clinical Trial Notification to TGA required for drug/device/biological trials
• Research Involving Ionising Radiation – PI letter OR Radiation Risk Assessment (see Radiation in research guidelines page)
• For Clinical Trials involving GMO/Gene Therapy
  • Institutional Biosafety Committee (IBC) approval
  • Licence for dealing with genetically modified organism (GMO)
• Victorian Specific Module (VSM) – for research projects with a site in Victoria, the VSM is required document. This can be completed and submitted in ERM.

Note: If you are experiencing difficulty with ERM, please see the Victorian Clinical Trials and Research ERM training tools page.

Site Specific Assessment (SSA). Create as a subform from HREA

Include:

• Curriculum Vitae, of all members of the research team including Site PIs and associate investigators – click for template
• Signature by site PIs, Associate investigators and head of department – signature instructions
• Research agreements – check the Research Agreements page to determine if required
• Fee payment form – see Fees page to confirm requirements and applicability
• For Deakin University led projects, an Annexure A is required. Please upload a partially executed (with DU signature) to ERM and RDU will secure Barwon Health Executive signature once the project is approved
• A Visiting Researcher Application form for all non-Barwon Health staff requesting access to identifiable BH patient data and/or requesting to come on site at BH to conduct their research project.

Submit your complete application (containing all supporting documents and signatures) via Ethics Review Manager (ERM) by clicking the ‘Submit’ button in the HREA form and SSA form

Once submitted, your application will be reviewed by the Barwon Health Human Research Ethics Committee (BH HREC). Please refer to the submission close and meeting dates of the BH HREC on the BH HREC page.

You will be prompted via email (address linked to your ERM account) to log into ERM and view any feedback, correspondence, and approvals relating to your application.

If further information is requested, you need to update the HREA form and/or upload/update any documents and re-submit your application via ERM.

Generate a reference number for your project via the Barwon Health Research Reference Number Generator if you have not already done so.

Please refer to our document naming guidelines before submitting your application.

Site Specific Assessment (SSA) – (ERM: select the SSA as a subform created from the HREA)

Include:

• HREC Approval listing Barwon Health as an approved site
• all documents listed in the HREC approval
• Site Specific Documents – PICF, PLS, posters
• Curriculum Vitae, of all members of the research team including Site PI and associate investigators
• Signature by site PI, Associate investigators and head of department – signature instructions
• Research agreements – See research agreements page to determine if required
• Fee payment form – see Fees page to confirm requirements and applicability
• If a Deakin University led study, an Annexure A is required. Please upload to ERM partially executed (with DU signature) and RDU will secure Barwon Health Executive signature once approved.
• Victorian Specific Module (VSM) – for research projects with a site in Victoria, the VSM is required document.
• Clinical Trials Only
  • Standard Form of Indemnity
  • Insurance Certificate
  • For clinical trials involving a drug, device or biological
    • Investigator Brochure
    • CTN/CTX – Clinical Trial Notification to TGA draft required
  • For clinical trials involving GMO/Gene Therapy
    • Institutional Biosafety Committee (IBC) Approval
    • Licence for dealing with genetically modified organism (GMO)
  • For clinical trials involving Radiation (see Radiation in research guidelines page)
    • Either a letter from PI stating radiation is standard of care OR Radiation Risk Assessment

Submit your complete application (containing all supporting documents and signatures) via Ethics Review Manager (ERM) by clicking the ‘Submit’ button on the SSA form.

Once submitted, your application will receive governance review by a Research Governance Officer within the RDU team. You will be prompted via email (address linked to your ERM account) to log into ERM and view any feedback, correspondence, and approvals/authorisations relating to your application. If further information is requested, you may to update the SSA form and/or upload/update any documents and re-submit your application via ERM.

Your project will also be reviewed by the Barwon Health Research Management Committee. Once approved, BH Executive research agreement signatures will be facilitated by RDU via DocuSign, and you will receive signed agreement and governance authorisation together.