Human Research Ethics Committee

The St Vincent's Hospital Melbourne (SVHM) Human Research Ethics Committee (HREC) is fully constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research 2023.

SVHM uses SAGE (St Vincent's Hospital Application for Governance and Ethics) as a one-stop portal for all ethics and governance application submission and post-approval management. User Guides are available on the Resources page. 

SVHM HREC can review and approve ethics for both public and private sites. For private sites, acceptance of National Mutual Acceptance (NMA) approval and final site authorisation remain at the discretion of the individual site.

HREC meeting dates

Closing dates apply to new high risk ethics applications only.
First in Human applications must be submitted two weeks prior to the closing date.

Submissions not reviewed at HREC meetings (no closing date):

SVHM site-specific information

New Ethics Application

When do you need a New Ethics Application

A new ethics application is required before commencing any human research study. The HREC reviews the application to ensure the study is scientifically sound, ethically justified, and that participant safety and rights are adequately protected.

You need to submit a new ethics application if you are:

  • Submitting an SVHM HREC application for a study that involves human participants, their data, or biological samples.
  • Introducing a sub-study with different endpoints from those previously approved, particularly if it represents a separate research question or study design.
  • Submitting for sites requiring NMA-certified HREC approval, including SVHM.

Ethics Application Submission and Review Process

  1. Plan your application: Closing dates apply to High-Risk Ethics Applications. Please refer to HREC Closing and Meeting Dates to plan your submission.
  2. Prepare the required documents, including the Human Research Ethics Application (HREA) completed in Ethical Review Manager (ERM).
  3. Submit the application via SAGE by uploading the HREA and all required supporting documents. Refer to SAGE User Guides for the following submission types:
    • Ethics-only submission – if the study is not conducted at any SVHM site.
    • Ethics and Governance submission (High-Risk or Multisite Study) – if the study involves an SVHM site.
  4. Please make sure your application has been successfully submitted.                 
  5. Eligibility and status check. You will be notified via email:
    • If the application is ineligible, please address the requested items and resubmit via SAGE (see SAGE User Guide on Responding to an Ineligible Application).
    • If the application is valid, it will be scheduled for review at the next HREC meeting. No further action required until after HREC review.
  6. Responding to queries – After the HREC review meeting, if queries are raised, you will need to submit your responses via SAGE (see SAGE Guide on Responding to a Letter of Query).
  7. Ethics approval – Once approved, you will receive an ethics approval notification via email, and the SVH Project will become active in SAGE.
If SVHM is a participating site: Ethics approval alone is not sufficient to commence research at SVHM. If SVHM is a participating site, you must also obtain governance authorisation by submitting a Site-Specific Assessment (SSA). See the New Governance Application section below. Contact Research Governance Unit via research.ethics@svhm.org.au if unsure.

Click here to View Required Documents for New Ethics Application

All documents can be found under Forms in the right-hand sidebar. Missing documents in the submission will result in an ineligible application and review delays. For more information on each required document, please refer to the Ethics Submission Guide.

Documents requiring signature: Scanned PDFs with a wet ink signature are accepted; however, SVHM only executes documents electronically. To request an electronic signature (DocuSign or Adobe Sign), please upload a Contract Submission Form with your submission in SAGE. Please refer to the SVHM Digital Signature Guidelines for further information.

 

1 Cover Letter and Checklist – Ethics – Mandatory
2 Fee Form – Mandatory; Please include remittance advice when paying with EFT
3 Human Research Ethics Application (HREA) Form – Mandatory
Please refer to the ERM User Guide for detailed instructions on how to create a HREA application in ERM. If you have difficulties, contact Infonetica on 02 9037 8404.
Note: For investigator-initiated studies where SVHM is the lead site, please include the following in the sponsor section of the HREA:
Sponsor name St Vincent's Hospital Melbourne
Sponsor contact Megan Robertson, 41 Victoria Parade, Fitzroy VIC 3065
Phone 03 9231 6970
Email research.ethics@svha.org.au
4 Victorian Specific Module (VSM) – Mandatory if Victorian sites are involved
5 Protocol or Research Plan – Mandatory
Protocol must have a footer that includes document name, version number and date.
6 Master Participant Information and Consent Form (PICF) – if participants are enrolled in the study
Templates are available on the Department of Health website. Please include the Version and Date in the PICF footer.
Reviewing HREC details for PICF
Reviewing HREC name St. Vincent's Hospital Melbourne HREC
Position HREC Executive Officer
Telephone (03) 9231 6970
Email Research.ethics@svhm.org.au
7 Patient-Facing Materials – such as surveys, brochures, advertisements or questionnaires
All documents must have a footer that includes document name, version number and date.
8 Medical Physicist Letter – if ionising radiation is involved
  • Radiation – Notification to the Reviewing HREC – for all studies involving ionising radiation
  • Medical Physicist Report – for studies involving ionising radiation additional to standard care. The report must be conducted by a medical physicist. One report must be submitted for each site seeking ethical approval.
9 Investigator Brochure (IB) – for studies involving drugs and/or devices
10 Form of Indemnity – HREC Review Only – required for all commercially sponsored trials
SVHM indemnified party details St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755
11 Certificate of Insurance – for all commercially sponsored clinical trials
12 Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign; available to download in Forms
13 Clinical Trial Notification Form (CTN) - Draft version – for use of unapproved therapeutic goods under the CTN scheme
As the TGA only acknowledges a CTN after ethics approval, please submit the TGA-acknowledged CTN via the acknowledgement pathway once ethics approval has been granted.
SVHM details for CTN form
HREC name St. Vincent's Hospital Melbourne HREC
HREC code EC00343
HREC contact officer Executive Officer of Research
HREC contact number 03 9231 6970
HREC contact email Research.ethics@svhm.org.au
Approving authority St. Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy VIC 3065
Approving authority officer Megan Robertson, Director of Research
Contact number 03 9231 6970
Contact email Research.ethics@svhm.org.au
14 Good Clinical Practice (GCP) Certificates – Mandatory for CPI only
15 Investigator Curriculum Vitae (CVs) – Mandatory for all PIs at each participating site, including the CPI

New Governance Applications

When do you need a New Governance Application

After ethics approval has been obtained from an NMA-certified HREC, governance authorisation must be obtained before conducting research at SVHM. Research must not commence until governance authorisation has been granted.
Please adhere to SVHM Site Specific Guidelines when preparing your submission.

New Governance Application Submission and Review Process

  1. Plan your submission: Site initiation activities and patient enrolment cannot commence until you have received governance authorisation and fully executed contracts.
  2. Prepare required documents, including a Site Specific Assessment (SSA) Form on ERM. Refer to the ERM User Guide for instructions. If you have difficulties, contact Infonetica on 02 9037 8404.
  3. Submit the application via SAGE by uploading the SSA and other required documents. Please refer to the SAGE User Guide for the appropriate submission type:
    • Ethics and Governance submission (High-Risk or Multisite Study) – if you received ethics approval from SVHM HREC.
    • Governance-Only submission – if you received ethics approval from another NMA HREC.
  4. Please make sure your application has been successfully submitted. We endeavour to respond within 10 working days once all required documents are received.
  5. Application status will be notified via email. If the application is ineligible or requiring more information, please address the queries via SAGE (see Responding to an Ineligible Application).
  6. Once approved, you will receive a final governance approval via email, the site project will be active in SAGE, and you may commence your study on the approved SVHM site(s).

Click to View Required Documents for New Governance Application

All documents can be found under Forms in the right-hand sidebar. Missing documents will result in an ineligible application and review delays. The Ethics Submission Guide can also be used for guidance on required documents.

Documents requiring signature: Scanned PDFs with a wet ink signature are accepted; however, SVHM only executes documents electronically. To request an electronic signature (DocuSign or Adobe Sign), please upload a Contract Submission Form with your submission in SAGE. Please refer to the SVHM Digital Signature Guidelines for further information.
1 Cover Letter and Checklist – Governance – Mandatory
2 Fee Form – Mandatory; please include remittance advice when paying with EFT
Governance Application Fees: If SVHM is the reviewing HREC, governance application fees can be waived if the governance application is submitted within 3 months of HREC approval.
3 HREC Approval Letter (including any amendment approval) – Mandatory
4 Original Human Research Ethics Application (HREA) Form – Mandatory
5 Site Specific Assessment (SSA) Form – Mandatory
Please refer to the ERM User Guide for detailed instructions on how to create an SSA application on ERM. If you have difficulties, contact Infonetica on 02 9037 8404.
6 Victorian Specific Module (VSM) – Mandatory
7 Protocol or Research Plan – Mandatory
Submit the original Protocol approved by the reviewing HREC.
8 Master Participant Information and Consent Form (PICF) – if participants are enrolled in the study
Submit all original Master PICFs approved by the reviewing HREC.
9 Site-Specific Participant Information and Consent Form (PICF) – if participants are enrolled in the study
Create the SVHM Specific PICF based on the reviewing HREC approved Master PICF. Both tracked and clean versions are required. The SVHM Specific PICF footer must include the document name, version and date. Recommended format:
Site Specific- [Protocol No.] SVHM Specific PICF [type e.g. Main / Optional genetic] Verx.x Date dd/mm/yyyy
Complaints Contact Person
Position Patient Liaison Officer at St Vincent's Hospital Melbourne
Telephone (03) 9231 1954
Email PLO@svhm.org.au
Local HREC Office Contact
Name St. Vincent's Hospital (Melbourne) Human Research Ethics Committee
Position HREC Executive Officer
Telephone (03) 9231 6970
Email Research.ethics@svhm.org.au
These details must appear exactly as shown above. Please refer to the site-specific guidelines for acceptable Catholic wording on the site-specific PICF.
10 Patient-Facing Materials – if participants are enrolled in the study
Such as surveys, brochures, advertisements or questionnaires. All documents must have a footer that includes document name, version number and date.
11 Medical Physicist Letter – if ionising radiation is involved
  • Radiation – Notification to the Reviewing HREC – for all studies involving ionising radiation.
  • Medical Physicist Report – for studies involving ionising radiation additional to standard care. The report must be conducted by a medical physicist at SVHM.
12 Investigator Brochure (IB) – for studies involving drugs and/or devices
Submit the original Investigator Brochure approved by the reviewing HREC.
13 Budget – as per sponsor or institution guidelines
14 Form of Indemnity – Standard – for all commercially sponsored trials where SVHM is providing premises for the conduct of the study
SVHM indemnified party details St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755
15 Research Agreement (CTRA or RCA)
A signed agreement between the sponsor and participating institution(s) outlining the roles, responsibilities, and terms for conducting the research or clinical trial.
Note
  • An RCA with SVHM details pre-inserted is available on the Forms page. Please note that only the Director of Research can sign on behalf of SVHM.
  • If an investigator-initiated study involves transferring data between SVHM and other sites, data transfer terms should be included in the RCA schedule.
  • If materials are transferred between sites, a Material Transfer Agreement (MTA) is required in addition to the RCA.
SVHM details for RCA
Institution St Vincent's Hospital (Melbourne) Limited
Address 41 Victoria Parade, Fitzroy VIC 3065
ABN 22 052 110 755
16 Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign
Please consult the SVHM Digital Signature Guidelines for further information.
17 Clinical Trial Notification Form (CTN) – for use of unapproved therapeutic goods under the CTN scheme
SVHM details for CTN form
HREC name St. Vincent's Hospital Melbourne Human Research Ethics Committee
HREC code EC00343
HREC contact officer HREC Executive Officer
HREC contact number 03 9231 6970
HREC contact email Research.ethics@svhm.org.au
Approving authority St. Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC, 3065
Approving authority officer Megan Robertson, Director of Research
Contact number 03 9231 6970
Contact email Research.ethics@svhm.org.au
18 Certificate of Insurance – for all commercially sponsored trials
Submit the original Certificate of Insurance approved by the reviewing HREC.
19 Investigator Good Clinical Practice (GCP) Certificates – Mandatory
Provide current and valid GCP certificates for: SVHM Principal Investigator and SVHM Associate Investigators.
20 Investigator Curriculum Vitae (CVs) – Mandatory
Provide a CV for: SVHM Principal Investigator and SVHM Associate Investigators.
21 CTMS Pre-Study Build Checklist Form – for Interventional Trials only

Post Approval Amendment – HREC Review (SVHM is the reviewing HREC)

When do you need an HREC Amendment

After your project gets ethics approval from an accredited HREC, you must submit an amendment for any changes to your study. The HREC must review and approve all amendments before you make the changes. This covers updates to the protocol, PICFs, IBs, research staff, patient documents, or study sites.

HREC Amendment Submission Process

  • Submit via SAGE: Complete an Amendment Request Form in SAGE and upload all required documents under the Ethics project linked to the SVH ID (e.g., 2026/SVH00001).
  • Required documents vary by amendment type. Document templates can be found in Forms in the right-hand sidebar menu. Only electronic copy of each document is required; hardcopies will not be accepted.
  • The three main amendment types in SAGE are:
    1. Permanent CPI/PI Change – Changes to the Chief or Principal Investigator
    2. General Amendment – Updates to the protocol, IB, PICF, participant-facing documents (PFD), or other administrative changes.
    3. Addition of Site – Adding a new study site, including full site, satellite site or recruitment site.
  • Documents with signatures: Scanned PDFs with a wet ink signature are accepted; however, SVHM only executes documents electronically. To request an electronic signature (DocuSign or Adobe Sign), please upload a Contract Submission Form along with your amendment request in SAGE.
  • Timeline: There is no closing date for amendment submissions. Once all required documents are received, you'll be notified via email that the amendment is under review. Each round of HREC Amendment Review usually takes 10–15 business days.

Required Documents for each HREC Amendment Type

Expand each section below to view required documents.

Change of Coordinating Principal Investigator (CPI) or Principal Investigator (PI)

Amending the CPI/PI ensures the study remains compliant, responsibilities are clear, participant safety is maintained, and the HREC and sponsor are informed.

CPI/PI Absence Duration Action Required
Less than 6 weeks No amendment required. Please ensure responsibilities are properly delegated.
6 weeks – 6 months Submit a temporary change of PI within 6 weeks of PI's absence. Notify HREC via Acknowledgement Form when original PI/CPI returns.
Over 6 months Submit a permanent change amendment.

Permanent Change of CPI/PI

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Change/Addition of Coordinating or Principal Investigator Form
  4. CV of the new CPI/PI
  5. GCP Certificate of the new CPI/PI – required for all CPIs, and for PIs employed at SVHM RGO sites.
  6. Updated Form of Indemnity – HREC Review Only – If commercially sponsored
  7. Updated Clinical Trial Notification (CTN) Form – For use of unapproved therapeutic goods under the CTN scheme
  8. Updated CTRA or RCA – if applicable
  9. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

Temporary Change of CPI/PI (If away for more than 6 weeks, less than 6 months)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Change/Addition of Coordinating or Principal Investigator Form
  4. CV of the new CPI/PI
  5. GCP Certificate of the new CPI/PI – required for all CPIs, and for PIs employed at SVHM RGO sites.
  6. Letter specifying dates of the temporary change to PI

General Amendment Type (Updated Protocol, IB, PICF, Patient Facing Documents, or other administrative changes including contracts)

Updated Protocol and/or Investigator's Brochure (IB)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Updated Protocol / Investigator Brochure – Including updated version numbers and dates
  4. Tracked Changes of the Protocol / Investigator Brochure
  5. Summary of Changes

Updated Participant Information and Consent Form (PICF)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Updated Participant Information and Consent Form (PICF) – Including updated version numbers and dates
  4. Tracked Changes of the PICF

Updated Participant Facing Documents

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Updated patient-facing documents – Including updated version numbers and dates
  4. Tracked Changes to the patient-facing documents

All Other Changes (Administrative)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Documents requiring review

Addition of Site (Full Site, Satellite Site, Recruitment Site)

  • Full Site: Conducts the full range of trial activities, including participant enrolment, consent, and study procedures. Following HREC approval of the addition of site amendment, separate governance authorisation must be obtained for this site.
  • Satellite Site: A separate location under a different ABN supporting the trial under the PI's oversight. May be teletrial or non-teletrial. Full SSA submission is required.
  • Recruitment Site: Used solely to recruit participants (e.g. flyers, posters, referrals). Participant consent is generally not obtained at these sites.
  • Service Site: Provides specific services only (e.g. radiology, pathology, pharmacy, standard care day surgery). Addition of service site is a site-specific process and does not require HREC approval.

For more information, refer to Satellite Service Recruitment Sites 2024.

Addition of a Full Site

Governance authorisation required for a SVHM site after amendment is approved before study commencement.

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. Change/Addition of Coordinating or Principal Investigator Form
  4. Site Medical Physicist Report – If ionising radiation is involved
  5. CV of the site Principal Investigator (PI)
  6. GCP Certificate of the site Principal Investigator (PI) – GCP is only a requirement for CPIs, SVHM & SVPH PIs
  7. Updated Form of Indemnity – HREC Review Only or Research Collaboration Agreement (RCA) – Form of Indemnity if commercially sponsored; RCA if investigator-initiated and unsponsored
  8. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign
  9. Updated Clinical Trial Notification (CTN) Form – For use of unapproved therapeutic goods under the CTN scheme

Addition of Satellite Site

Please refer to Satellite Site SOP for more information.

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. SVHM Addition of Satellite/Recruitment/Service Site Form
  4. Letter of Support from Site
  5. CV & GCP Certificate for PI/AI responsible at the satellite site – required for all CPIs, and for PIs employed at SVHM RGO sites.
  6. Form of Indemnity – HREC Review Only – For commercially sponsored studies
  7. Insurance Certificate – For commercially sponsored studies
  8. CTRA or Research Collaboration Agreement (RCA) – CTRA for commercially sponsored; RCA for investigator-initiated unsponsored — both when adding a rural site not under the same legal entity, and SVHM is the primary site
  9. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

Addition of Recruitment Site

Please refer to Recruitment Site SOP for more information.

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. SVHM Addition of Satellite/Recruitment/Service Site Form
  4. Letter of Support from Site
  5. CV & GCP Certificate for PI/AI – If applicable; GCP is only a requirement for CPIs, SVHM & SVPH PIs
  6. Patient docs – Documents used for recruitment of participants from this site (e.g. flyers)
  7. Updated Form of Indemnity – HREC Review Only – If commercially sponsored
  8. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

Post Approval Amendment – Governance Review (SVHM is a participating site)

When do you need a Governance (Site-Specific) Amendment

After your project receives ethics approval from an accredited external HREC, a site-specific amendment must be submitted to SVHM Research Governance Unit (RGU). This is required for updates affecting the SVHM site, such as changes to the protocol, Investigator Brochures (IBs), Participant Information and Consent Forms (PICFs), research staff, participant-facing documents, or SVHM study site details.

RGO Amendment Submission Process

  • Submit via SAGE: Complete an Amendment Request Form in SAGE and upload all required documents under the governance project linked to the SSA ID (e.g., 2026/SSA00001).
    • Users may need specific permissions to access amendment forms (see Guide on Form Access).
    • If you cannot locate your project or submit the amendment, contact research.directorate@svha.org.au for assistance.
    • For instructions on locating and submitting the Amendment Form, refer to the SAGE User Guides (Post-Approval Submissions).
  • Required documents vary depending on the amendment type. Templates are available under Forms in the right-hand sidebar menu. Only electronic copy of each document is required; hardcopies will not be accepted.
  • Main RGO amendment types are:
    1. Change of Principal Investigator (PI) – only applicable to PIs employed at SVHM
    2. General Amendment – Updates to the protocol, IB, PICF, participant-facing documents (PFDs), agreements or other administrative updates.
    3. Addition of Site – Including a full site, satellite site, recruitment site, or service site.
  • Legal documents: Scanned PDFs with wet-ink signatures are accepted; however, SVHM executes agreements electronically only. To request an electronic signature (DocuSign or Adobe Sign), please upload a Contract Submission Form with your amendment request in SAGE.
  • Timeline: There is no closing date for RGO amendment submissions. Once all required documents are received for each round of review, you will receive a response from the RGO within 7–10 business days.

Required Documents for each RGO Amendment Type

Expand each section below to view required documents.

Change of SVHM Principal Investigator (CPI/PI)

Amending the CPI/PI ensures the study remains compliant, responsibilities are clear, participant safety is maintained, and the RGU and sponsor are informed.

CPI/PI Absence Duration Action Required
Less than 6 weeks No amendment required. Please ensure responsibilities are properly delegated.
6 weeks – 6 months Submit a temporary change of PI within 6 weeks of PI's absence. Notify the RGO via Acknowledgement Form when the original PI/CPI returns.
Over 6 months Submit a permanent change amendment.

Change of SVHM Principal Investigator (Permanent)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. HREC Amendment Approval
  4. Change/Addition of Coordinating or Principal Investigator Form
  5. CV of the new CPI/PI
  6. GCP Certificate of the new CPI/PI
  7. Updated Form of Indemnity – Standard – If commercially sponsored
  8. Updated Clinical Trial Notification (CTN) Form – For use of unapproved therapeutic goods under the CTN scheme
  9. Updated CTRA or RCA – whichever applicable
  10. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

Change of SVHM Principal Investigator (Temporary – more than 6 weeks, less than 6 months)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. HREC Amendment Approval
  4. Change/Addition of Coordinating or Principal Investigator Form – Either scanned wet ink signature or DocuSign/Adobe Sign signature
  5. CV of the new CPI/PI
  6. GCP Certificate of the new CPI/PI
  7. Letter specifying dates of the temporary change to PI

Please notify the RGO via Acknowledgement Form when the original PI/CPI returns.

General Amendment Type (Updated Protocol, IB, PICF, Patient Facing Documents, or other administrative changes)

Updated Protocol and/or Investigator's Brochure (IB)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. HREC Amendment Approval
  4. Updated Protocol / Investigator Brochure – Including updated version numbers and dates
  5. Tracked Changes of the Protocol / Investigator Brochure
  6. Summary of Changes

Updated Participant Information and Consent Form (PICF)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. HREC Amendment Approval
  4. Updated Participant Information and Consent Form (PICF) – Including updated version numbers and dates
  5. Tracked Changes of the PICF

Updated Participant Facing Documents

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. HREC Amendment Approval
  4. Updated patient-facing documents
  5. Tracked Changes to the patient-facing documents

All Other Changes (Administrative)

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. HREC Amendment Approval
  4. Documents requiring review

Addition of Site (SVHM as Primary Site)

This RGO Amendment is required when adding an external site to support an existing SVHM-authorised project. The external site may act as a service site, recruitment site, or satellite site, undertaking specific study activities on behalf of the SVHM site.

This amendment applies only where the external site is supporting the SVHM site and is not operating as a fully authorised research site. Activities at the external site are typically limited to defined tasks such as participant identification or recruitment, conducting specific procedures, or providing study-related services.

If SVHM is being added as a full site, service site, recruitment site, or satellite site to an existing project, a new Governance Application must be submitted instead of a Governance Amendment.

Addition of Satellite Site

Please click here to view the guideline document for what qualifies under this category of site addition.

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. SVHM Addition of Satellite/Recruitment/Service Site Form
  4. Letter of Support from Site
  5. CV & GCP Certificate for PI/AI responsible at the satellite site – GCP is only a requirement for CPIs, SVHM & SVPH PIs
  6. Form of Indemnity – HREC Review Only – For commercially sponsored studies
  7. Insurance Certificate – For commercially sponsored studies
  8. CTRA or Research Collaboration Agreement (RCA) – CTRA for commercially sponsored trials; RCA for investigator-initiated unsponsored trials — both when adding a rural site not under the same legal entity as the primary site, and when SVHM is the primary site
  9. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

Addition of Recruitment Site

Please click here to view the guideline document for what qualifies under this category of site addition.

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. SVHM Addition of Satellite/Recruitment/Service Site Form
  4. Letter of Support from Site
  5. CV & GCP Certificate for PI/AI – If applicable; GCP is only a requirement for CPIs, SVHM & SVPH PIs
  6. Patient docs – Documents that will be used for recruitment of participants from this site (e.g. flyers)
  7. Updated Form of Indemnity – HREC Review Only – If commercially sponsored
  8. Contract Submission Form – For all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

Addition of Service Site

Please click here to view the guideline document for what qualifies under this category of site addition.

  1. Amendment Request Form – Completed in SAGE
  2. Fee Form – Please include remittance advice when paying with EFT
  3. SVHM Addition of Satellite/Recruitment/Service Site Form
  4. Service Agreement – Only required if SVHM (primary site) is utilising an external service site to conduct study activities

Annual Progress and Final Report Requirement

Annual Reporting is Mandatory

  • The completion and submission of an annual report are mandatory for all projects as a condition of ethical approval and governance authorisation.
  • Failure to submit a satisfactory annual report will result in the withdrawal of HREC approval and/or governance authorisation, leading to study suspension. All study activities must cease immediately and cannot resume until a satisfactory annual report has been submitted and approved.
  • You must not publish or present your research findings while ethical approval is withdrawn.
  • Final reports or Site Closure Reports must be submitted when project is completed, abandoned/terminated or closed.

Submission Timeline

  • Due date: 1 May each year
  • If approvals are granted between Jan - April: The first report is due 1 May the following year
  • From 2025, Annual Progress Reports cannot be submitted before 1 May (SAGE submission will be disabled prior to this date)
  • Final reports and site closure reports can be submitted at any time upon project completion or abandonment
  • Failure to submit within 45 days after 1 May may result in study suspension. You will receive a reminder email every 2 weeks from April each year until the report is submitted or the study is suspended.
  • You will receive a response to your progress report within 2 months, but the turnaround time may be extended during peak periods.

How to Submit

  • All Annual Reports and Final Reports are to be submitted under the relevant projects on SAGE. Please refer to the SAGE User Guide for instructions on how to locate the report form.
  • The type of report generated in SAGE depends on the current study status selected in the report form. Please refer to the definitions of study status in the Annual Report Submission Guide.
    • Annual Progress Report is generated when status is set to: Not Yet Commenced, In Progress, or Continuing
    • Final Report / Site Closure Report is generated when status is set to: Completed, Closed (post-analysis), Abandoned, or Terminated
  • Only users with the appropriate study role can submit report forms. Please refer to the sections below for report type, submission location, and responsible submitter.

Reporting Level and Submission Responsibilities

Project Type Form Type & Location Who Submits
Ethics only project
Study reviewed by SVHM HREC, but no SVHM site is involved		 Progress / Final Report (HREC Form)
Located in SVH Project → Milestone tab 

Investigator-initiated: CPI

Commercially sponsored: Sponsor representative
Governance only project
Study reviewed by an external HREC, SVHM as participating site		 Site Report / Closure Form (RGO Form)
Located in SSA Project → Milestone tab		 PI only
Single-Site Study
Where SVHM is both the HREC and the only participating site		 Site Report / Closure Form (RGO Form)
Located in SSA Project → Milestone tab		 PI only
Multi-Site Study
Where SVHM is the HREC and one of the participating sites		 Project level: Progress / Final Report (HREC Form)
Located in SVH Project → Milestone tab 

Investigator-initiated: CPI

Commercially sponsored: Sponsor representative
Site level: Site Report / Closure Form (RGO Form)
Located in SSA Project → Milestone tab		 PI only
External Site Closure
Closure of a non-SVHM site approved under SVHM HREC		 External Site Closure Form (HREC Form)
Located in SVH Project → Form tab

Investigator-initiated: CPI

Commercially sponsored: Sponsor representative
Having issues with SAGE access? Please contact research.directorate@svha.org.au.
Unsure about the reporting requirement? Please contact the Annual Report team at svhm.ResearchAnnualR@svha.org.au.

Annual Safety Report Requirement

Mandatory Requirement

The completion and submission of an annual safety report is mandatory for all clinical trials involving an investigational medicinal product (IMP) or investigational medical device.
The sponsor is responsible for reporting to the reviewing HREC, in accordance with Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016). Only the Sponsor or CPI can sign off and submit the ASR Form.

NOTE

Annual Safety Reports are not the same as safety event reports (SAEs) or annual progress reports.

Safety events report individual incidents, annual progress reports track study progress, and annual safety reports provide a yearly summary of safety data; Each must be submitted separately.

When to Submit

Annual Safety Reports are due on the ANNIVERSARY OF STUDY APPROVAL until study completion.

What Annual Safety Reports Should Include

  • A brief description and analysis of new and relevant findings.
  • For IMPs not on the TGA Register — a brief analysis of the safety profile of the IMP and its implications for participants, taking into account all safety data.
  • A brief discussion of the implications of the safety data to the trial's risk-benefit ratio.
  • A description of any measures taken or proposed to minimise risks.
  • A Development Safety Update Report (DSUR) may substitute for an Annual Safety Report.

How to Submit

  • Please submit Annual Safety Reports (ASR) via SAGE. See How to submit an Annual Safety Report (ASR).
  • Only the Sponsor or CPI can sign off and submit the Annual Safety Report in SAGE.
  • DSURs may serve as the annual safety report but are not required. They can be uploaded to the Annual Safety Report Form on SAGE.
For further information, please contact Reception on 03 9231 6970 or email SAE.ClinicalTrial@svha.org.au.

Safety Event Reporting

This guidance applies to clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. It is also broadly applicable to all clinical trials involving therapeutic goods. 

For further details, please refer to the NHMRC Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (2016).

How to Submit: All safety reports for St Vincent's Hospital Melbourne must be submitted via SAGE and signed by the Chief Investigator or the Sponsor. See the SAGE Resource Pack for instructions.

Definitions and Reporting Timelines

Safety Event Definition Action Required and Reporting Timeline
Adverse Event (AE)
 Any untoward medical occurrence in a participant administered a medicinal product, not necessarily causally related to treatment. N/A; Unless it meets the definition of SAE.
Adverse Reaction (AR)
 Any untoward and unintended response to an IMP related to any dose administered. Requires a reasonable possibility of causal relationship. N/A;  Unless it meets the definition of SAR.
Serious Adverse Event / Reaction (SAE / SAR) Any adverse event or adverse reaction that results in:
  • Death
  • Life-threatening illness or injury
  • Hospitalisation or prolongation of existing hospitalisation
  • Persistent or significant disability or incapacity
  • Congenital anomaly or birth defect

PI must inform the Sponsor within 24 hours of becoming aware.

Not required to be reported to HREC unless it meets the definition of a SSI or USM.
Significant Safety Issue (SSI)
Including early termination or temporary halt of trial due to significant safety issues

A safety issue that could adversely affect participant safety or materially impact the trial's continued ethical acceptability or conduct.

  • An SAE associated with trial procedures that requires modification of trial conduct
  • A hazard to the patient population, such as lack of efficacy of an IMP used for a life-threatening disease
  • A major safety finding from a newly completed animal study (e.g. carcinogenicity)
  • Trial halted or terminated for safety reasons, including DSMB recommendations such as an increase in the frequency or severity of an expected adverse reaction
  • Single case events leading to an USM (e.g. toxic epidermal necrolysis, agranulocytosis, hepatic failure)

Sponsor must report to the TGA, HREC and Investigators within 15 calendar days of becoming aware 

Note: if an USM is required for SSI, the 72-hour deadline applies instead.
Urgent Safety Measure (USM) A measure required to eliminate an immediate hazard to a participant's health or safety. May be implemented before HREC or institution approval. Reasons, measures taken, and further actions planned must be communicated.

Sponsor must report to the TGA, HREC and Investigators within 72 hours of the measure being taken.

HREC is not required to approve USMs but may consider whether any proposed actions are appropriate, such as the submission of amendment.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
IMP trials only		 An adverse reaction that is both serious and unexpected — not consistent with the investigator's brochure or product information.

Sponsor must report to the TGA:

  • Fatal/life-threatening: within 7 calendar days
  • All others: within 15 calendar days

If occurs at SVHM, PI must report to the RGU within 72 hours.

Individual SUSARs do not need to be reported to the HREC unless it meets the definition of a SSI or USM.
Unanticipated Serious Adverse Device Effect (USADE)
IMD trials only		 A serious adverse device effect not previously identified in the current risk analysis report.

Sponsor must report to TGA:

  • Fatal/life-threatening: within 7 calendar days
  • All others: within 15 calendar days

If occurs at SVHM, the PI must report to the RGU within 72 hours.
Important: A serious breach report must be submitted to the HREC for any safety reports not submitted within the required timeframe, as delayed reporting may pose a risk to participant safety.

Safety Reporting Responsibilities

Sponsor

Principal Investigator (PI)

  • Evaluate all safety information from investigators and other sources
  • Report all SUSARs (IMP) or USADEs (IMD) to the TGA within required timeframes
  • Notify the TGA, HREC and investigators of all significant safety issues within required timeframes
  • Provide the HREC with an annual safety report
  • Review and update the investigator's brochure at least annually
  • Ensure all safety reporting responsibilities are appropriately allocated or delegated
  • Capture and assess all AEs at the site in accordance with the protocol
  • Report to Sponsor within 24 hours: all SAEs (except those not needing immediate reporting), congenital anomaly/birth defects, and USMs instigated at the site
  • Report to institution within 72 hours: all significant safety issues and SUSARs/USADEs arising from the local site
  • SVHM site PIs must report all related SAEs, SUSARs, and USADEs occurring in SVHM participants to the research office

Frequently Asked Questions (FAQs)

  1. Who is responsible for submitting safety reports?
    The Sponsor is responsible for reporting safety events to the reviewing HREC in accordance with the NHMRC guideline. The site PI must provide a copy to the site RGO if the event involves a site participant.

  2. Do I need to submit AEs and SAEs that are unrelated to SVHM?
    No. It is not a requirement to report and submit AEs and SAEs that are unrelated to St Vincent's Hospital Melbourne.

  3. Do I need to submit AEs and SAEs that are listed on the investigator's brochure?
    No. AEs and SAEs that are listed on the investigator's brochure do not need to be submitted to the HREC.

  4. For related SAEs that do not meet the definitions of USM or SSI, do they need to be submitted?
    No. Related SAEs that do not fall under the definitions of USM or SSI in the NHMRC guideline do not need to be reported to the SVHM HREC. The site must inform the Sponsor and document the communication in the study folder.

  5. Who is responsible for submitting SUSARs and USADEs?
    The Sponsor is required to report all SUSARs and USADEs to the Therapeutic Goods Administration (TGA). Line listings do not need to be reported to the HREC.

  6. What if the Sponsor's global policies require reporting of individual SUSARs and six-monthly line listings to HREC?
    SVHM HREC will accept and acknowledge individual SUSAR cases and six-monthly line listings if mandated by the Sponsor's global policies.
For further information, please contact Reception on 03 9231 6970 or email SAE.ClinicalTrial@svha.org.au.

Serious and Non-Serious Breaches

NHMRC 2018 Update

The NHMRC introduced a new document in 2018 called “Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018”. 

The European Union (EU) Clinical Trials Regulation (536) introduced the term ‘serious breach’ to describe the sub-set of deviations that should be reported to review bodies and the Integrated Addendum to ICH E6 R1: Guidelines for Good Clinical Practice (ICH E6 R2) requires the sponsor to perform a root cause analysis for ‘noncompliance [deviations] that significantly affect or has the potential to significantly affect human subject protection or reliability of trial results.  

Although GCP requires all deviations to be reported to the trial sponsor, not all deviations need to be reported to the reviewing bodies.

HRECs only need to be made aware of the small sub-set of deviations that have a significant impact on the continued safety or rights of participants, or the reliability and robustness of the data generated in the clinical trial (hereinafter referred to as serious breaches).

Serious breaches occurring at a site should also be reported by the investigator to their institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.

Serious Breach

A breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:

  • The safety or rights of a trial participant
  • The reliability and robustness of the data generated in the clinical trial

Serious breaches must be reported to the Reviewing HREC and RGO site at which the breach occurred within 7 days.

Non-Serious Breach

A minor, deviation from Good Clinical Practice or to the protocol that is unlikely to affect:

  • The safety or rights of a trial participant
  • The reliability and robustness of the data generated in the clinical trial

Non-Serious Breaches must only be reported to the RGO site at which the breach occurred according to the local governance timeline requirements. SVHM requires the submission of quarterly (every 3 months) non-serious breach logs.

Serious Breaches vs. Non-Serious Breaches

Please see our document "Breach Report Guidelines" for more information as to what needs to be reported to the RGO/HREC here.

For additional information, please view the NHMRC "Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018"

Reporting Serious Breaches

  • Please submit serious breach reports to the reviewing HREC and the RGO site at which the breach occurred
  • From October 2023 onwards, all breach reports are submitted via SAGE - see SAGE Resource Pack for instructions on how to submit
  • ONLY E-COPIES are required for breaches
  • Contact:: research.ethics@svhm.org.au

Reporting of Serious Breaches by the Sponsor –

Breach Report - Serious (Sponsor)

Sponsors have the primary responsibility of determining whether any suspected breach meets the definition of a serious breach.

Sponsor is required to:

  • Report serious breaches to the Reviewing HREC within 7 calendar days of confirming a serious breach has occurred and provide follow-up reports when required.
  • Notify the TGA and the reviewing HREC if the serious breach leads to the closure of the site.
  • Report to the TGA any serious breach that involves a defective product that may have wider implications for the supply chain for that marketed product:
  • Commercial sponsors report to the TGA using existing product surveillance processes
  • Non-commercial sponsors (e.g. universities) may either report to the TGA directly or to the Marketing Authorisation Holder/manufacturer (who would report to the TGA).

Reporting of Serious Breaches by Third Parties –

Breach Report - Suspected (Third Party)

A third party refers to any entity (other than the trial sponsor) wishing to report a suspected breach.

A third party (e.g. trial sites) may identify a serious breach and report it directly it to the reviewing HREC.

This would usually be appropriate if:

  • The investigator/institution has good evidence that a serious breach has occurred but the sponsor disagrees with their assessment and is unwilling to notify the HREC
  • The investigator/institution has become aware that the sponsor may have committed a serious breach

Reporting Non-Serious Breaches

  • Please submit non-serious breach reports ONLY to the RGO site at which the breach occurred
  • see SAGE Resource Pack for instructions on how to report a non-serious breach

If you have any queries please contact the Research Governance Unit on 9231 6970 or e-mail research.ethics@svhm.org.au

Reporting of Non-Serious Breaches -

Breach Report - Non-Serious

The sponsor in collaboration with the site Principal Investigator should complete this form to report a non-serious breach -deviation.

It is the responsibility of the Principal Investigator to report the non-serious breach to the RGO at which the breach occurred.

Non-Serious Breaches must only be reported to the RGO site at which the breach occurred according to the local governance timeline requirements. SVHM requires the submission of quarterly (every 3 months) non-serious breach logs.

Authorised Prescriber Scheme

What is the Authorised Prescriber Scheme?

There are circumstances where patients may require access to medicines, biologicals or medical devices that have not been approved for supply by the TGA. The Authorised Prescriber scheme allows authorised medical practitioners to supply specific unapproved therapeutic goods to a specific class of patients, without seeking approval or notification on an individual patient basis, as is the case with the Special Access Scheme.

Note: The following are not justifications for use of an unapproved good:
  • The unapproved good is less expensive than any approved treatment
  • Personal preference for an unapproved good


Requirements to become an Authorised Prescriber

To become an Authorised Prescriber, applicants must:

  • Be a medical practitioner with general registration, including limited registration, or specialist registration with the Australian Health Practitioner Regulation Agency (AHPRA)
  • The training and expertise appropriate for the condition being treated and the proposed use of the product
  • The ability to best determine the needs of the patient
  • The ability to monitor the outcome of therapy

Application Process

An HREC or specialist college reviews and endorses applications from medical practitioners seeking to become an Authorised Prescriber of an unapproved therapeutic good. To obtain endorsement, the practitioner must submit a clinical justification for the proposed use. If approved, the HREC or specialist college issues a letter of endorsement, which the practitioner uses to support their TGA application.

  1. Obtain an HREC Endorsement Letter or an endorsement from a specialist college (if applicable).
  2. Complete an online application using the SAS & Authorised Prescriber Online System to submit to the TGA.
    • You will need to provide a HREC approval letter or Specialist College endorsement letter, including a declaration that all necessary documentation has been reviewed.
  3. Receive decision letter from TGA.
  4. Comply with ongoing TGA requirements, including
    • appropriate informed consent and prescription process,
    • six monthly reporting and
    • adverse events/product defects reporting.

For further information, please visit the TGA website.

Required Documents for HREC Endorsement on New Authorised Prescriber Applications

Please complete the Cover Letter to the HREC (template available) and prepare all supporting documents listed below. Once complete, submit the full package by email to research.ethics@svha.org.au.

1 Cover Letter to the HREC – signed
The template is available on the Forms page
The letter should detail
  1. Prescriber details
  2. Qualifications, specialty, training and experience
  3. Details of the unapproved therapeutic good:
    • Indication and use (including treatment duration and route of administration)
    • Product description
  4. Clinical justification and evidence — include clinical rationale, efficacy and expected benefits, and a summary supporting evidence
  5. Approved treatments for the same indication — previous and future attempts, appropriateness of approved treatments and justification as to why the unapproved good is more appropriate.
  6. Site(s) of prescribing and administration
  7. Safety, risks and monitoring information — covering adverse effects, toxicology, effectiveness measures, adverse event investigation and reporting process, and monitoring information (monitoring schedule, duration and interval)
  8. List of supporting documents
2 Fee Form – please include remittance advice when paying with EFT
3 Curriculum Vitae
Current CV of the applicant prescriber, including relevant clinical experience, training, and any involvement in clinical trials or compassionate access programs.
4 Patient Information and Consent Form (PICF)
Note The use of unapproved goods is considered experimental. The Authorised Prescriber must obtain written informed consent from each patient, advising them of:
  • The TGA has not evaluated the good’s safety, quality or efficacy
  • Possible benefits and risks of its use
  • The possibility of unknown side effects
  • Any alternative approved goods
If the good is derived from biological tissues including blood or plasma, the medical practitioner must use the consent form available on the TGA website.
5 Supporting Evidence - as applicable
  1. Product information / prescribing information from an overseas regulator (if applicable)
  2. Randomised controlled trials
  3. Non-randomised controlled trials
  4. Individual case studies / case series
  5. Global Regulatory Status/Overseas regulatory product information – If available, documentation of overseas approval status. The global regulatory status of the unapproved good may affect the level of evidence required in the application.
  6. Consensus opinion of specialist colleges and societies

Reporting Requirements of an Authorised Prescriber

Once approved, Authorised Prescribers must comply with the following ongoing reporting obligations to the TGA and HREC.
The TGA may revoke Authorised Prescriber status if:

  • The HREC or specialist college withdraws their approval or endorsement
  • The conditions applied to the approval are not met
  • A suitable alternative good becomes available and is entered on the ARTG
  • Significant safety concerns arise regarding the unapproved therapeutic good

 

Requirement Details
Six-Monthly Periodic Reporting
To TGA and HREC
    • When to report: Reports must be submitted for the periods 1 January to 30 June and 1 July to 31 December, within one month of the reporting period ending.
    • How to report: Submit via the SAS & Authorised Prescriber Online System. Provide a copy to SVHM HREC at research.ethics@svha.org.au.
    • What to report: Number of new patients commenced on treatment (or number of devices supplied) and total number of patients treated during the period.
    Note
    • A report must be submitted even if no patients were treated — enter zero for new and total patients
    • The online system will not allow submission if any fields are left blank
    • No new Authorised Prescriber applications will be processed until all outstanding reports are completed and submitted
Adverse Events and Product Defects
To TGA and HREC

Unapproved therapeutic goods have generally not been evaluated for safety, quality and efficacy and may pose unknown risks. Authorised Prescribers are responsible for reporting all adverse events and product defects.

  • Report any suspected adverse event or product defect to the TGA within 15 calendar days of becoming aware of it
  • Fatal or life-threatening adverse drug reactions must be reported to the TGA within 7 calendar days, followed by a complete report within a further 8 calendar days if necessary
  • After reporting to the TGA, provide a copy of the report to SVHM HREC at research.ethics@svha.org.au.

Refer to the TGA website for available reporting methods.

Codes

SVHM Radiation Safety Licence Number: 300042061

SVHM TGA Sponsor Reference Number: 28204

SVHM CTN Code: 30514

SVHM HREC Code: EC00343

Contact Us

For more information visit the Research Governance Unit Contact page