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) – for use of unapproved therapeutic goods under the CTN scheme
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 and Final Report Requirements

Annual Safety Reports

Due on the anniversary of study approval

  • For clinical trials involving an investigational medicinal product or investigational medical device
  • The completion and submission of an annual safety report is part of the conditions of ethical approval for all projects.
  •  A DSUR may substitute for an annual safety report.
  • For further information, please contact Reception on 03 9231 6970 or email SAE.ClinicalTrial@svha.org.au

Annual Reports Should Generally Include

  • A brief description and analysis of new and relevant findings
  • 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

Submitting Annual Safety Reports (ASR)

  • Please submit Annual Safety Reports (ASR) via SAGE. See How to submit an Annual Safety Report (ASR)
  • 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.
  • DSURs may serve as the annual safety report, but are not required. They can be uploaded to the Annual Safety Report Form on SAGE.

Annual Project/Progress Reports

Due 01 May - Annual Reports for projects that have been approved in January to April in any year do not need to be submitted until 01 May the following year.

Failure to submit progress reports within 45 days following the 01 May submission deadline may lead to a suspension of the ethical approval for the study.

Due to the high volume of annual progress reports, any documents submitted alongside them will be treated as supporting material only. If you require HREC acknowledgement of these documents, please submit them separately via the Acknowledgement Request pathway in SAGE.

Important update (2025)

Effective 2025, all annual progress report cannot be submitted before 1 May to ensure continuous reporting with no gaps between reports, maintaining data completeness and accuracy.

 

  • The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
  • Acknowledgement of a submitted annual progress report will generally be provided within 2 months of submission - this timeline may be extended due to the significant volume of reports received. 
  • For further information, please contact Research Integrity and Compliance Assistance on 03 9231 6972 or email: svhm.ResearchAnnualR@svha.org.au

Submitting Annual Reports

All Annual Reports and Final Reports are to be submitted under the relevant projects on SAGE. Different report forms are required depending on the project types (Summary below). For more information regarding how to submit an annual report on SAGE, please refer to these Annual Report Submission Guides.

Project Type Report Form Required  Where to Submit  Whose responsibility to submit
Ethics only project
 - no SVHM site is involved		 Progress/Final Report (HREC)  Milestone tab under the SVH Project
  • Investigator-initiated study: CPI
  • Commercially-sponsored study: Sponsor
Governance only project
 - study reviewed by an external HREC		 Site Report/Closure Form (RGO) -
one report for each site		 Milestone tab under the SSA Project for each site   PI only
Both Ethics and Governance project
 - Single-site study where SVHM is both the HREC and the only participating site		 Site Report/Closure Form (RGO) Milestone tab under the SSA Project  PI only
Both Ethics and Governance project
 - Multi-site study where SVHM is the HREC and one of the participating sites		 Both HREC and RGO report forms are required Milestone tab under the SVH Project for HREC Form;
and the SSA Project for each RGO Form/s

 HREC Report:

  • Investigator-initiated study: CPI
  • Commercially-sponsored study: Sponsor

 RGO Report: PI only
Ethics project with a closure of an external site
- Closure of a non-SVHM RGO site approved under SVHM HREC		 External Site Closure Form (HREC) Form tab under the SVH Project
How to submit an external site closure form
  • Investigator-initiated study: CPI
  • Commercially-sponsored study: Sponsor

Safety Reporting (SAEs, SSIs, USMs)

*Annual Safety Report Information in Header above, under "Annual Reporting Requirements"

For more details on safety reporting please view the "NHMRC Guide on Safety monitoring and reporting in clinical trials involving therapeutic goods" on our Resources page.

This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.

Submitting Safety Reports

  • Please submit Safety Reports via SAGE. See SAGE Resource Pack for instructions.
  • All safety reports for St. Vincent's Hospital Melbourne RGU must be signed by the Chief Investigator or the Sponsor.

IMPORTANT: Please note a serious breach report must be submitted to HREC for all safety reports that were not reported within the required timeframe, as they may pose a risk to the study participant.

Definitions

Adverse Reaction

Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Serious Adverse Event (SAE)

Any adverse event/adverse reaction that results in:

  • Death,
  • Life-threatening, requires hospitalisation or prolongation of existing hospitalisation,
  • Results in persistent or significant disability or incapacity
  • Congenital anomaly or birth defect

Suspected Unexpected Serious Adverse Event (SUSAR)

An adverse reaction that is both serious and unexpected. It is also not consistent with the investigator brochure or product information.

Significant Safety Issue (SSI)

A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.A SSI can be a SAE that is associated with the study (Definitely related, Probably related and Possibly related).

  • A serious adverse event that could be associated with the trial procedures and that requires modification of the conduct of the trial
  • A hazard to the patient population, such as lack of efficacy of an IMP used for the treatment of a life-threatening disease.
  • A major safety finding from a newly completed animal study (such as carcinogenicity)
  • A temporary halt/termination of a trial for safety reasons
    Recommendations of the Data Safety Monitoring Board, where relevant for the safety of participants, such as an increase in frequency or severity of an expected adverse reaction
  • Single case events (e.g. toxic epidermal necrolysis, agranulocytosis, hepatic failure) that lead to an urgent safety measure.

Urgent Safety Measure (USM)

A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety. Note: This type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented before seeking approval from HRECs or institutions.

Serious Adverse Events (SAEs)

  • In the event of a Serious Adverse Event (SAE) Investigators are required to report to Sponsor within 24 hours of becoming aware of the SAE.
  • The sponsor, on becoming aware of the reported SAE made by Investigators, will be required to notify HREC and TGA based on the type of SAE and the associated timeline as described below:
  • St Vincent’s Hospital Melbourne requires its site principal investigators (or their delegates) to report all related SAEs, SUSARs, and USADEs occurring in participants at SVHM.

USM

Within 72 hours of measures being taken

The HREC is not required to approve USMs but may consider whether any proposed actions are appropriate

SSI – involving notification of an amendment

Within 15 calendar days of sponsor being aware of the issue

Sponsors should submit to the HREC an amendment relating to any revised trial documentation, without undue delay

Temporary halt of a trial for safety reasons

Within 15 calendar days of the sponsor decision to halt the trial

Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

Early termination of a trial for safety reasons

Within 15 calendar days of the sponsor decision to halt the trial

Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

SUSAR – Suspected unexpected Serious Adverse Reactions

Life-threatening AUS – within 7 calendar days

All other – within 15 calendar days

Must be reported to the Therapeutic Goods Australia (TGA)

Events at SVHM must be reported by the site PI to the research office.

USADE – Unanticipated Serious Adverse Device Effect

Life-threatening AUS – within 7 calendar days

All other – within 15 calendar days

Must be reported to the Therapeutic Goods Australia (TGA)

Events at SVHM must be reported by the site PI to the research office.

*If St Vincent’s Hospital Melbourne is nominated as the trial sponsor, St Vincent’s Hospital Melbourne will assume the Sponsor responsibility and abide by the above SAE reporting timeline.

Frequently Asked Safety Reporting Questions

1. Who is now responsible for submitting Safety Report?

The Sponsor is responsible for reporting a safety event to the reviewing HREC in accordance to with the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC 2016). The Site PI needs to provide a copy to the site RGO as required if it involves the site participant.

2. Do I need to submit AEs and SAEs that are unrelated?

It is not a requirement to report and submit AES and SAEs that are unrelated to St. Vincent's Hospital Melbourne (SVHM).

3. Do I need to submit AEs and SAEs that are related?

AEs and SAEs that are listed on the investigator’s brochure will not need to be submitted to the HREC.

4. For related SAEs that do not fall under the definitions of USM, SSI in the NHMRC guidelines, do they need to be submitted? And what’s the reporting timeframe?

For related SAEs that do not fall under the definitions of USM and SSI in the NHMRC guidelines, they do not have to report to the SVHM HREC committee. Site will need to inform Sponsor about the SAE and have the communication documented in the study folder.

5. Who is now responsible for submitting SUSARs and USADEs?

The Sponsor is required to report all SUSARs to the Therapeutic Goods Australia.

6. Do I need to submit SUSARs and Six-monthly line listings to HREC?

SUSARs need to be reported to the institution by the PI. Line listings do not need to be reported to the HREC.

7. What if Sponsor is required by their global policies mandating the reporting of individual case of SUSARSs and six-monthly line listing to HREC?

St Vincent’s Hospital, Melbourne HREC will accept and acknowledge the individual case of SUSARS and six-monthly line listing if it mandated in the Sponsor global policies.

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 an 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, as is the case with the Special Access Scheme.

What are the requirements to be an authorised prescriber?

To be an Authorised Prescriber the medical practitioner must have:

  • The training and expertise appropriate for the condition being treated and the proposed use of the product
  • The Authorised Prescriber must be able to best determine the needs of the patient
  • To monitor the outcome of therapy.

How do medical practitioners become an authorised prescriber?

The following are the steps to becoming an Authorised Prescriber:

  1. Obtain HREC Approval or Specialist College endorsement
  2. Submit an application to TGA
  3. Receive decision letter from TGA

Process of Review

After HREC Approval has been granted, you will need to submit an application to the TGA for evaluation. This submission should include:

  • A completed Authorised Prescriber Scheme application form  (Obtained from the TGA Website). Ensure the indication listed on this form is the indication. 
  • HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed
  • Please visit the TGA Website for more guidance regarding the application process

Please email Authorised Prescriber Applications to: research.ethics@svhm.org.au.

New Authorised Prescriber Applications

1. Authorised Prescriber Application Form

 1x e-copy

2. Fee Form – please include remittance advice when paying with EFT

 1x e-copy

3. Letter to the HREC

*Please submit a letter detailing:

1. Name of Prescriber applying to be an Authorised Prescriber

2. Qualifications, specialty, training and experience

3. Details of the indication for which the good will be used

4. Clinical justification for its use

5. Approved treatments for the same indication:

  • Have they been attempted?
  • Why are they appropriate?
  • Will they be attempted prior to prescribing the unapproved good?
  • Why is the proposed unapproved good a more appropriate treatment?

6. Details of the site(s) at which the goods will be used

7. How the risk associated with the use of an unapproved good will be managed, including:

  • The monitoring that will be undertaken
  • The process of investigating and reporting adverse events

*The following are not justifications for the use of an unapproved good:

  • That the unapproved good is less expensive than any approved treatment
  • Personal preference for an unapproved good
 1x e-copy signed

4. Information of Use of Unapproved Goods

*Please provide the following details regarding the unapproved treatment as below:

Description

Medicines

Biologicals

Medical Devices

Trade Name

Name of Biological

Name of Medical Device

Strength/concentration

N/A

N/A

Dosage Form

Dosage Range (if applicable)

Active ingredient

Sponsor

If the good is approved for the indication in another jurisdiction

Use

Route of Administration or type of sample for IVDs

Duration of Treatment

Safety

Any known/expected adverse effects, risks and safety issues

Related toxicology

the unapproved good’s efficacy and expected benefits
1x e-copy

5. Monitoring Information

*Please include:

  • How the medical practitioner will determine if the use is effective
  • How the medical practitioner will determine whether an adverse event has occurred
  • What monitoring is required
  • How it will be done
  • Interval and duration of monitoring

1x signed e-copy

6. Efficacy and Safety

*Please include:

  • The unapproved good’s efficacy and expected benefits
  • Any known/expected adverse effects,
  • Risks and safety issues
  • Related toxicology

1x signed e-copy

7. Evidence

*The application should contain appropriate sources of evidence to support the use of the unapproved good. The sources of evidence for data, with the highest level of significance first, in decreasing order are:

  1. Product information documents (of equivalent) (if the good is approved by an overseas regulator)
  2. Randomised controlled trials
  3. Nnon-randomised controlled trials
  4. Individual case studies
  5. Consensus opinion of specialist colleges and societies

1x e-copy

8. Global Regulatory Status – if available

*The global regulatory status of the unapproved good may affect the level of evidence required in the application.

1x e-copy

9. Informed Consent

*The use of unapproved goods is considered experimental. The Authorised Prescriber must obtain the informed consent of each patient for whom they prescribe the unapproved good.

The Authorised Prescriber must advise patients in the Informed Consent of the following:

  • TGA has not have evaluated the unapproved good’s safety, quality and efficacy
  • Possible benefits and risks of its use
  • Possibility that there may be unknown side effects
  • Any alternative approved goods

It is best practice to obtain informed consent in writing using a standard form.

If the unapproved good is, however, derived from biological tissues including blood or plasma, the medical practitioner must obtain informed consent using the form available on the TGA website.

1x e-copy

10. Current Prescriber CV

 1x e-copy

After HREC Approval had been granted 

You will need to submit an application to the TGA for evaluation. This submission should include:

  • a completed Authorised Prescriber Scheme application form (Obtained from the TGA Website) . Ensure the indication listed on this form is the indication.
  • HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed

Reporting Requirements of an Authorised Prescriber

Six-Monthly Periodic Reporting – to TGA and HREC
  • Number of patients treated during the six-month period
  • Needs to be sent within one month after the reporting period
  • Report must be sent even if no patients have been treated

Reporting Adverse Events and Product Defects – to HREC
  • Report any adverse event or product defect related to the unapproved good
  • Must be reported within 15 calendar days of learning of it

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