Mercy Health: Research Ethics & Governance

Transition of research ethics and governance from Mercy Health to St Vincent's Hospital Melbourne (SVHM):

SVHM Human Research Ethics Committee (HREC) and Research Governance Office (RGO) are pleased to provide ethics and governance review for new Mercy Health Research applications. Submit via SAGE (refer to SAGE Resource Pack).

From 2025, all human research ethics and governance services for new Mercy Health research projects will be provided by St Vincent’s Hospital Melbourne.

Review Schedule:

SVHM HREC meetings for high-risk applications occur fortnightly. For low-risk applications, the turnaround time is approximately 10 business days.

Training Requirements:

All Higher Risk project investigators must provide evidence of both Good Clinical Practice (GCP) training and Research Integrity (RI) training. Any ICH GCP E6 (R2) equivalent certificate will be accepted, as will any Australian University or Australian Clinical Trials Education Centre (A-CTEC) RI certificate. A-CTEC GCP and RI training courses can be completed online at your own convenience and are available free to Mercy Health (and other health service) employees.

Lower Risk project investigators are strongly encouraged to complete these courses as well.

Recognition of prior review:

SVHM HREC accepts National Mutual Acceptance (NMA) applications and Mercy Health will recognize prior HREC review by an appropriately certified HREC. NMA-approved projects must be submitted to the SVHM Research Governance Office (RGO) for governance review and approval before commencement.

 

Amendments and reports for existing Mercy Health HREC approved projects

During an interim period, any amendments, progress, or safety reports for existing Mercy Health HREC approved projects should be submitted via Mercy Health Research Directorate.

General enquiries:

For general questions related to research processes, contact Mercy Health Research Directorate.

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 St Vincent's Hospital Application for Governance and Ethics (SAGE), as a one-stop portal for all High and Low Risk Ethics/Governance application submission and post-approval management of research projects.

Quick reference guides and video tutorials on how to navigate SAGE are available here.

Committee Information

HREC Meeting Dates

Chief Principal Investigator / Principal Investigator Responsibilities in Trials

Resources for Researchers

The closing dates only apply to NEW HIGH RISK ETHICS APPLICATIONS. All First in Human Ethics Application must be submitted two weeks prior to the HREC submission closing date.

Content Editor
 Please review the key concepts below. Note that unsponsored projects conducted at Mercy Health will not incur any costs for Mercy Health employees.

The primary difference between low-risk and high-risk applications is the review process. High-risk applications generally require an additional two weeks for review, as they must be discussed at a fortnightly committee meeting. Low-risk applications, however, are reviewed by a subcommittee outside of these meetings and are not subject to the same scheduling constraints. Beyond this review difference, there is virtually no impact on how your project will proceed. The risk classification is simply an internal determination to decide whether the full committee or a subcommittee should review your application.

Ethics review is the process through which the ethical merit of your project is assessed, ensuring it meets established ethical standards and is justified in its aims and methods. Any modifications to your project, such as changes in study design, methods, or procedures, alter the ethically approved framework. Therefore, any modifications must be submitted for additional ethical approval to ensure continued adherence to ethical standards.

Governance, on the other hand, involves the oversight of ethically approved processes at the institutional level. Governance applications serve to inform the institution of the study and seek approval to implement the ethically approved protocol within its setting. Governance reviews focus on site-specific requirements, such as contracts, site-specific consent forms, and departmental approvals, ensuring that the study complies with the institution’s standards, resources, and regulatory requirements.

For single-site studies conducted at Mercy Health, governance approval is typically granted at the same time as ethics approval. However, if your study is not classified as low-risk or involves sites outside of Mercy Health, you will need to submit a separate governance application.

Annual report submissions open on May 1st each year, and submitting an annual report is mandatory to maintain active approval for your study. However, if your project was approved after January 1st of this year, you do not need to submit an annual report until the following year.

Each submitted annual report extends your study’s approval for an additional year. As long as you submit the annual report each year by the deadline, your study approval will remain current, allowing your project to continue without interruption.

SVHM HREC provides an expedited review pathway for all projects which are considered as “Low-Risk.”

There are no closing dates applicable for Low-Risk Research.

The SVHM HREC is fully constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2023), including all updates.

For any questions regarding submission, please contact the Research Governance Unit on: 03 9231 6970 or email: research.ethics@svhm.org.au

 

SVHM uses St Vincent's Hospital Application for Governance and Ethics (SAGE), as a one-stop portal for all High and Low Risk Ethics/Governance application submission and post-approval management of research projects.

Quick reference guides and video tutorials on how to navigate SAGE are available here.

 

To qualify for Low-Risk Review, the project must not specifically target any of the cohorts listed below, nor involve the procedures or additional risks outlined:

 

  • Women who are pregnant (Non-interventional, Observational studies and Surveys may be considered Low Risk)
  • Children or young people under the age of 18 (Non-interventional, Observational studies and Surveys may be considered Low Risk)
  • Persons with an intellectual disability or mental impairment of any kind
  • Individuals highly dependent on medical care
  • Individuals unable to provide informed consent
  • People involved in illegal activities
  • Prisoners or people on parole
  • Research specifically recruiting Aboriginal and/or Torres Strait Islander people
  • Persons not usually considered to be vulnerable but would be considered vulnerable in the context of this research project
  • Additional clinical interventions and/or therapies
  • Human genetic research or gene technology
  • Derivation or use of human stem cells
  • Discomfort or risk beyond that of routine care
  • Deception of participants, concealment or covert observation
  • Examining potentially sensitive or contentious issues
  • Additional Radioactive substances / ionizing radiation
  • Assisted reproductive technology (ART)
  • Xenotransplantation
  • Toxins / mutagens / teratogens / carcinogens
  • Collection, use or disclosure of identifiable information

 

The HREC reserves the right to promote projects to high risk at any time. If you believe your project should be considered for the Low-Risk Review Pathway despite involving a criterion mentioned above, please provide a brief justification. Please note that Quality Assurance and Internal Audits fall under a separate classification below.

The HREC reviews studies such as:

  • Non-interventional
  • Qualitative
  • Laboratory or basic science
  • Observational studies
  • Clinical research involving drugs and devices. This includes both experimental agents, and those approved for use by the Therapeutic Goods Administration (TGA)
  • Non-standard clinical interventions. This includes both experimental agents, and those approved for use by the TGA

Process of Review for a Low-Risk Ethics Application

Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents. Low-Risk submissions are reviewed within 10 business days of submission.

 To Submit a New Ethics Application
  1. Please make sure to complete the Human Research Ethics Application (HREA) form on ERM.
  2. SVHM will only consider PICF templates from the Department of Health.
  3. You will need to upload the HREA and required documents to SAGE. Watch how to complete New Ethics Submission via SAGE here; more SAGE Resources available on the Quick Reference Guide page.
  4. You will receive a confirmation email that your study has been successfully submitted.
  5. If your application is ineligible, you will receive a notification via email, please provide requested items via SAGE (Responding to an Ineligible Application)
  6. If your application is valid, the application will proceed to the next HREC meeting - you will receive a notification via email.
  7. After the HREC review meeting, if there are any queries, you will then need to submit your response via SAGE - Responding to Letter of Query
  8. Finally you will receive an Ethics approval via email, and the Ethics project will be active on SAGE. 
  9. After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at Mercy Health. Research must not commence until governance authorisation has been granted. 
    See governance requirement below.

Required Documents for Ethics Application

Please expand the 'New HREC Ethics Application' section to view the required documents list. The main difference between Low-Risk and HREC reviews is the review type: HREC reviews are conducted by a full committee on a regular schedule, while Low-Risk reviews are handled by a subcommittee out of session. The document lists are the same.

Required Documents for Low-Risk Governance Applications

Please expand the 'New Governance Application' section to view the required documents list. There is no difference in the process for submitting low-risk and high-risk governance applications. However, high-risk governance submissions may require additional documents, such as Investigator Brochures, CTNs, and Medical Physicist Letters.

For single-site studies conducted at Mercy Health, governance approval is typically granted at the same time as ethics approval. However, if your study is not classified as low-risk or involves sites outside of Mercy Health, you will need to submit a separate governance application.

Process of Review of a High-Risk Ethics Application

Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents. High-Risk Ethics Application closing dates here (not applicable to Low-Risk Ethics Application).

 To Submit a New Ethics Application
  1. Please make sure to complete the Human Research Ethics Application (HREA) form on ERM.
  2. SVHM will only consider PICF templates from the Department of Health.
  3. You will need to upload the HREA and required documents to SAGE. Watch how to complete New Ethics Submission via SAGE here; more SAGE Resources available on the Quick Reference Guide page.
  4. You will receive a confirmation email that your study has been successfully submitted.
  5. If your application is ineligible, you will receive a notification via email, please provide requested items via SAGE (Responding to an Ineligible Application)
  6. If your application is valid, the application will proceed to the next HREC meeting - you will receive a notification via email.
  7. After the HREC review meeting, if there are any queries, you will then need to submit your response via SAGE - Responding to Letter of Query
  8. Finally you will receive an Ethics approval via email, and the Ethics project will be active on SAGE. 
  9. After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at Mercy Health. Research must not commence until governance authorisation has been granted. 
    See governance requirement below.

 

    Required Documents for Ethics Application

      Legal documents: please make sure to send through a PDF version of any legal documents required as part of the submission. These can be signed:

      • In wet ink - please submit a scanned copy of the wet ink signature
      • DocuSign/Adobe Sign - please make sure that a Contract Submission Form is submitted.

      Please consult the SVHM Digital Signature Guidelines for further information. 

      All documents can be found under 'Forms' in the right hand side bar. Please click here to be redirected. Missing documents in the submission will result in ineligible application and review delays.

      1. Cover Letter and Checklist - Ethics – Mandatory

      1x e-copy

      2. Fee Form – This is only required for commerical sponsors and external entities wishing to do research at Mercy Health

      Please include remittance advice when paying with EFT

      1x e-copy

      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 on the ERM. If you still have troubles you can contact Infonetica on 02 9037 8404.

      Note: For an investigator-initiated studies where Mercy Health is the lead site, please include the following information within the sponsor section of the HREA:

      Sponsor name: Mercy Hospitals Victoria Ltd

      Sponsor contact details: Grace Wijnen, Level 2, 12 Shelley St, Richmond, VIC, 3121

      Ph. (03) 8458 4808. Email: gwijnen@mercy.com.au

      1x e-copy

      4. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved

      1x e-copy

      5. Protocol or Research Plan – Mandatory

      Protocol must have a footer that includes document name, version number and date

        1x e-copy

        6. Master Participant Information and Consent Form (PICF) – if participants are enrolled in the study

        Different templates are available on the Department of Health website.

        IMPORTANT: SVHM HREC will only consider PICF templates from the Department of Health.

        Please use the template(s) that are appropriate for the type of research you are conducting.

        • Non-Interventional
        • Interventional
        • Participant Partner Pregnancy
        • Health and Social Sciences

        Participant Information and Consent Form Footer needs to include the Version and Date. Please see below for recommendation:

        Master Template - [Protocol No.]National Mutual Acceptance PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy

        Reviewing HREC Approving this Research and HREC Executive Officer Details

        Reviewing HREC Name

        St. Vincent’s Hospital Melbourne HREC

        Position

        HREC Executive Officer

        Telephone

        (03) 9231 6970

        Email

        Research.ethics@svhm.org.au

        *Please note: these details must appear exactly as it is shown below

        1 x e-copy
         

        7. 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.

        		  1x e-copy
         

        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 that is additional to standard care. The report MUST be conducted by a medical physicist. One report must be submitted for each site seeking ethical approval.
        		  1x e-copy

        9. Investigator Brochure (IB) – for studies involving drugs and/or devices 

        		  

        1x e-copy

        10. Form of Indemnity - HREC Review Only – for all commercially sponsored clinical trials where SVHM is providing premises for the conduct of HREC review

        SVHM Indemnified Party Details

        St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755

        What is Required? - Insurance for Clinical Trials Information and Guide (2020)

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
         11. 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.         		 1x e-copy 

        12. Clinical Trial Notification Form (CTN) – for use of unapproved therapeutic goods under the CTN scheme. To be completed by the sponsor, typically a commercial sponsor, or in the case of an investigator-initiated study, Mercy Health.

        Mercy Health Details For Use When Completing the Form

        HREC Name:

        St. Vincent’s Hospital Melbourne HREC
        HREC Code: EC00343

        HREC Contact Officer:

        Dr Tam Nguyen, Executive Officer of Research

        HREC Contact Number:

        03 9231 6970

        HREC Contact Email:

        Research.ethics@svhm.org.au

        Approving Authority:

        		  Mercy Hospitals Victoria Ltd

        Approving Authority Officer:

        		  Grace Wijnen

        Contact Number:

        		  Ph. (03) 8458 4808

        Contact Email:

        		  gwijnen@mercy.com.au
        		 

        1x e-copy

        13. Certificate of Insurance – for all commercially sponsored clinical trials

        What is Required? - Insurance for Clinical Trials Information and Guide (2020)

        		  

        1x e-copy

        14. Investigator Clinical Practice (GCP) Certificates & Research Integrity Training Certificates– Mandatory

        Provide a current and valid GCP & Research Integrity Training Certificate for the following study personnel:

        • For Multi-site study - Coordinating Principal Investigator & Investigators (At Mercy Health)
        • For Single-site study - Principal Investigator & Investigators (At Mercy Health)

        Please note that it is expected an updated GCP certificate be submitted for acknowledgment upon expiry. A GCP certificate is valid for 3 years.

        		  

        1x e-copy

        15. Investigator Curriculum Vitae (CVs) – Mandatory

        Provide a Curriculum Vitae for the following study personnel:

        • For Multi-site study - The Principal Investigators of each site & Investigators (At Mercy Health)
        • For Single-site study - Principal Investigator & Investigators (At Mercy Health)
        		  

        1x e-copy

        Process of Review

        Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents.

        After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at Mercy Health. Research must not commence until governance authorisation has been granted. Single-site studies at Mercy Health may have governance issued at the same time as ethics approval.

        • There is no closing date for Governance Applications. Applications must be complete at the time of submission.
        • Please adhere to SVHM Site Specific Guidelines.
        • We will endeavour to provide a response within 10 working days once all necessary paperwork has been submitted.
        • Submission must be received within 3 months of ethical approval (if SVHM reviewing HREC) or fee will be required.

        How to Submit a Governance Application

        1. Please make sure to complete a Site Specific Assessment (SSA) form on ERM
        2. Then complete the Governance application by submitting via SAGE, 

          See Quick Reference Guide here. Videos tutorials available below:

        3. You will receive a confirmation email that your study has been successfully submitted.
        4. If your application is ineligible, you will receive a notification via email, please provide requested items via SAGE (Responding to an Ineligible Application)
        5. If there are any queries, you will then need to submit your response via SAGE - Responding to Letter of Query
        6. Finally, you will receive a final governance approval via email, and the Site project will be active on SAGE.
        7. You can then commence your study at the approved Mercy Health site(s).

        Required Governance Documents

        Legal documents: please make sure to send through a PDF version of any legal documents required as part of the submission. These can be signed:

        • In wet ink - please submit a scanned copy of the wet ink signature
        • DocuSign/Adobe Sign - please make sure that a Contract Submission Form is submitted. We will also accept a scanned copy of the signed PDF.

        Please consult the SVHM Digital Signature Guidelines for further information. 

        All documents can be found under 'Forms' in the right hand side bar. Please click here to be redirected. Missing documents in the submission will result in ineligible application and review delays.

        1. Cover Letter and Checklist - Governance – Mandatory

        1x e-copy

        2. Fee Form – This is only required for commerical sponsors and external entities wishing to do research at Mercy Health

        Please include remittance advice when paying with EFT

        		  1x e-copy

        3. HREC Approval Letter (including any amendment approval) – Mandatory

        		 1x e-copy

        4. Original Human Research Ethics Application (HREA) Form – Mandatory

        1x e-copy

        5. Site Specific Assessment (SSA) Form – Mandatory

        *Please refer to the ERM User Guide for detailed instructions on how to create a SSA application on the ERM. If you still have troubles, you can contact Infonetica on 02 9037 8404.

        		  

        1x e-copy

        6. Victorian Specific Module (VSM) – Mandatory

        		  1x e-copy

        7. Protocol or Research Plan – Mandatory

        Submit the original Protocol approved by the reviewing HREC

        		 1x e-copy

        8. Master Participant Information and Consent Form (PICF) – if participants are enrolled in the study

        Submit all the original Master PICFs approved by the reviewing HREC.

        		  1x e-copy

        9. Site-Specific Participant Information and Consent Form (PICF) – if participants are enrolled in the study & the study is multi-site.

        Create the Mercy Health Specific Participant Information and Consent Form based on the Reviewing HREC Approved Master PICF.

        Both tracked and clean Mercy Health Specific Participant Information and Consent Form Version are required for submission.

        Mercy Health Specific Participant Information and Consent Form Footer needs to include the Document name, Version and Date. Please see below for recommendation:

        Site Specific- [Protocol No.] Mercy Health Specific PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy

        Complaints Contact Person

        Position

        Consumer Liaison Officer

        Telephone

        		 (03) 8416 7783

        Email

        		 feedback@mercy.com.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

        *Please note: these details must appear exactly as it is shown below

        Please refer to the site-specific guidelines for acceptable Catholic wording on the site-specific PICF.

        		  1x e-copy

        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.

        		  1x e-copy

        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 that is additional to standard care. The report MUST be conducted by a medical physicist at Mercy Health.
        		  1x e-copy

        12. Investigator Brochure (IB) – For studies testing an 'unapproved' drug or device (i.e., a new drug or device or one used for a new indication).

        Submit the original Investigator Brochure approved by the reviewing HREC. 

        		  1x e-copy

        13. Budget – as per sponsor or institution guidelines

        		  1x e-copy

        14. Form of Indemnity - Standard – for all commercially sponsored trials where Mercy Health is providing premises for the conduct of the study

        Mercy Indemnified Party Details

        Mercy Hospitals Victoria Ltd
        Level 2, 12 Shelley St, Richmond, VIC, 3121
        Contact for notices:         Grace Wijnen
        Ph.         (03) 8458 4808
        Email:         gwijnen@mercy.com.au

        What is Required? - Insurance for Clinical Trials Information and Guide (2020)

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        15.Clinical Trial Research Agreement (CTRA) – for commercially sponsored, multi-site clinical trials

        -or-

        16. Research Collaboration Agreement (RCA)– for investigator initiated, multi-site clinical trials

        Mercy Health Details for RCA:

        • Mercy Hospitals Victoria Ltd
          Level 2, 12 Shelley St, Richmond, VIC, 3121
          Contact for notices:           Grace Wijnen
          Ph.           (03) 8458 4808
          Email:           gwijnen@mercy.com.au

        Please note that only the Chief Medical Officer can sign off on behalf of the institution, the principal investigator does not have the authority to sign off on behalf of the institution.

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        17. 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. 

        		  1x e-copy
         

        18. Clinical Trial Notification Form (CTN) – for use of unapproved therapeutic goods under the CTN scheme

        Mercy Health Details for Use When Completing the Form:

        Approving Authority:

        		 Mercy Hospitals VIC Ltd

        Approving Authority Officer:

        		  Grace Wijnen

        Contact Number:

        		  (03) 8458 4808

        Contact Email:

        		  gwijnen@mercy.com.au

        		 

        1x e-copy

        19. Certificate of Insurance – for all commercially sponsored trials

        Submit the original Certificate of Insurance approved by the reviewing HREC.

        		  

        1x e-copy

        20. Investigator Clinical Practice (GCP) Certificates & Research Integrity Training Certificates– Mandatory

        Provide a current and valid GCP & Research Integrity Training Certificate for the following study personnel:

        • Principal Investigator & Investigators (At Mercy Health)

        Please note that it is expected an updated GCP certificate be submitted for acknowledgment upon expiry. A GCP certificate is valid for 3 years.

        		  

        1x e-copy

        21. Investigator Curriculum Vitae (CVs) – Mandatory

        Provide a Curriculum Vitae for the following study personnel:

        • Mercy Health  Principal Investigator
        • Mercy Health  Associate Investigators
        		  

        1x e-copy

        Process of Amendment Review

        After ethics approval has been obtained from an accredited HREC for your project, you may be required to submit an amendment if changes are required to your study. All amendments must be reviewed and approved by a HREC before they are undertaken. Amendments include any changes to the protocol, PICFs, IBs, research personnel, patient-facing documents or sites involved.

        • There is no closing date for amendment submissions. 
        • Please adhere to SVHM Site Specific Guidelines. 
        • We will endeavour to have a response within 10 working days once all necessary paperwork has been submitted. 

        To Submit an Amendment to an Ethics Project:

        1. Permanent CPI/PI Change (more than 6 months)
        2. General Amendment (temporary CPI/PI Change, Update in Protocol/IB, PICF, Participant Facing Documents (PFD), and all other administrative changes)
        3. Addition of Site (Full Site, Satellite Site, Recruitment Site, Service Site)

        Please Note:

        • Once ethics approval is granted, the site documents need to be updated. If the site documents are submitted alongside the ethics application, they can all be updated at the same time.
        • All active high-risk projects will be been migrated to SAGE,  you will need to locate the ethics project to submit the amendment request.
          If you cannot locate your project, please contact research.directorate@svha.org.au for access to the migrated project. Please include the title or the ERM/Local Mercy Health reference number in the email.

        Required Documents for Different Amendment Types

        Legal documents: please make sure to send through a PDF version of any legal documents required as part of the submission. These can be signed:

        • In wet ink - please submit a scanned copy of the wet ink signature
        • DocuSign/Adobe Sign - please make sure that a Contract Submission Form is submitted or a scanned PDF.


        Please consult the SVHM Digital Signature Guidelines for further information. 

        All documents can be found under 'Forms' in the right hand side bar. Please click here to be redirected. *Please note: we will not be asking for hard copies to be submitted at this time.

        Change of Principal Investigator (Permanent)

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy

        3. Change/Addition of Coordinating or Principal Investigator Form

        		  

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        4. CV of the new CPI/PI

        		  

        1x e-copy

        5. GCP Certificate of the new CPI/PI

        		  

        1x e-copy

        6. Updated Form of Indemnity - HREC Review Only – if commercially sponsored

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        7. Updated Clinical Trial Notification (CTN) Form - for use of unapproved therapeutic goods under the CTN scheme

        		  

        1x e-copy

        8. Updated CTRA or RCA – only for multi-site studies where Mercy Health is acting as the sponsor

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
        9. Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign 1x e-copy

        General Amendment: Change of Principal Investigator (Temporary - less than 6 months)

        1. Amendment Request Form

        		  

        1x e-copy

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

        1x e-copy

        3. Change/Addition of Coordinating or Principal Investigator Form

        		 1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature) 

        4. CV of the new CPI/PI

        1x e-copy

        5. GCP Certificate of the new CPI/PI

        1x e-copy

        6. Letter specifying dates of the temporary change to PI

        		  

        1x e-copy

        General Amendment: Updated Participant Facing Documents

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy

        3. Updated patient-facing documents - including updated version numbers and dates

        		  

        1x e-copy

        4. Tracked Changes to the patient-facing documents

        1x e-copy

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

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy

        3. Updated Protocol/ Investigator Brochure – including updated version numbers and dates

        1x e-copy

        4. Tracked Changes of the Protocol/Investigator Brochure

        		  

        1x e-copy

        5. Summary of Changes

        Note* An updated PICF will be required if participant procedures (including their data) have changed.

        		  

        1x e-copy

        All Other Changes (Administrative)

        1. Amendment Request Form

        1x e-copy

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

        		  

        1x e-copy

        3. Documents requiring review

        		  

        1x e-copy

        General Amendment: Updated Participant Information and Consent Form (PICF) 

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy

        3. Updated Participant Information and Consent Form (PICF) – including updated version numbers and dates

        		  

        1x e-copy

        4. Tracked Changes of the PICF

        		  

        1x e-copy

        To learn more about site types - please access the guidance document under Resources for Researchers.

        Addition of a Full Site

        Governance authorisation required for a Mercy Health site after amendment is approved before study commencement

        1. Amendment Request Form

        		  

        1x e-copy

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

        1x e-copy

        3. Change/Addition of Coordinating or Principal Investigator Form

        		  

        1x e-copy

        4. Site Medical Physicist Report – if ionising radiation is involved

        1x e-copy

        5. CV of the site Principal Investigator (PI)

        		  

        1x e-copy

        6. GCP Certificate of the site Principal Investigator (PI)

        1x e-copy

        7. Updated Form of Indemnity - HREC Review Only  – if commercially sponsored

        -or-

        7. Research Collaboration Agreement (RCA) – if investigator initiated, unsponsored

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
        8. Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign
        		 1x e-copy

        9. Updated Clinical Trial Notification (CTN) Form - for use of unapproved therapeutic goods under the CTN scheme

        1x e-copy

        1. Amendment Request Form

        1x e-copy

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

        		  

        1x e-copy
        3. SVHM Addition of Satellite/Recruitment/Service Site Form  

        1x e-copy
        4. Letter of Support from Site 1x e-copy
        5. CV & GCP Certificate for PI/AI responsible at the satellite site 1x e-copy

        6. Form of Indemnity - HREC Review Only  - for commercially sponsored studies

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
        7. Insurance Certificate - for commercially sponsored studies  1x e-copy

        8. CTRA - for commercially sponsored trials adding a rural site not under the same legal entity as primary site

        -or-

        8. Research Collaboration Agreement (RCA) – if investigator initiated, unsponsored trials adding a rural site not under the same legal entity as primary site

        		 1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
        9. Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign
        		 1x e-copy

        Addition of Recruitment Site

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

        1. Amendment Request Form

        1x e-copy

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

        		  

        1x e-copy
        3. SVHM Addition of Satellite/Recruitment/Service Site Form  

        1x e-copy
        4. Letter of Support from Site 1x e-copy
        4. CV & GCP Certificate for PI/AI - if applicable 1x e-copy
        5. Patient docs - documents that be used for recruitment of participants from this site (eg. flyers) 1x e-copy

        6. Updated Form of Indemnity - HREC Review Only  – if commercially sponsored

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
        7. Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign

        Process of Review

        After ethics approval has been obtained from an accredited HREC for your project, you may be required to submit an amendment if changes are required to your study. All amendments must be reviewed and approved by a HREC before they are undertaken. Amendments include any changes to the protocol, PICFs, IBs, research personnel, patient-facing documents or sites involved.

        • There is no closing date for amendment submissions. 
        • Please adhere to SVHM Site Specific Guidelines
        • We will endeavour to have a response within 10 working days once all necessary paperwork has been submitted
         To Submit a RGO Amendment to a Site-Only Project:
        • Please complete your amendment request via SAGE. Ethics projects are given an SSA ID (year/SSAxxxxx), example 2022/SSA01010.
          video guide: Amendment Submission Guide for a Site Project (SVHM is the reviewing HREC)
        • Required documents vary depending on the Type of Amendment Request. There are two main types of amendment request on SAGE:
        1. Permanent PI Change (more than 6 months)
        2. General Amendment (temporary PI Change, Update in Protocol/IB, PICF, Participant Facing Documents (PFD), and all other administrative changes)

        Please Note:

        • For a SVHM-approved ethics project where Mercy Health is also a participating site, please submit an amendment request for the Ethics project only, you do not need to submit a site amendment again.
        • All active projects have been migrated to SAGE,  you will need to locate the site project to submit the amendment request.
          If you cannot locate your project, please contact research.directorate@svha.org.au for access to the migrated project. Please include the title or the ERM/Local Mercy Health reference number in the email.
        • All Investigators need to be added to the research project through the submission of a CMORT on SAGE.

        Required Documents for Different Amendment Types

        Legal documents: please make sure to send through a PDF version of any legal documents required as part of the submission. These can be signed:

        • In wet ink - please submit a scanned copy of the wet ink signature
        • DocuSign/Adobe Sign - please make sure that a Contract Submission Form is submitted 


        Please consult the SVHM Digital Signature Guidelines for further information. 

        All documents can be found under 'Forms' in the right hand side bar. Please click here to be redirected.

        Change of Mercy Health Principal Investigator (Permanent)

        1. Amendment Request Form

        1x e-copy

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

        		  

        1x e-copy
        3. HREC Amendment Approval  

        1x e-copy

        4. Change/Addition of Coordinating or Principal Investigator Form

        		  

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        5. CV of the new CPI/PI

        1x e-copy

        6. GCP Certificate of the new CPI/PI

        		 1x e-copy

        7. Updated Form of Indemnity - Standard – if commercially sponsored

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        8. Updated Clinical Trial Notification (CTN) Form - for use of unapproved therapeutic goods under the CTN scheme

        		  

        1x e-copy

        9. Updated CTRA or RCA – only for multi-site studies

        		 1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
        10. Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign
        		 1x e-copy

        Change of Mercy Health Principal Investigator (Temporary - less than 6 months)

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy
        3. HREC Amendment Approval  

        1x e-copy

        4. Change/Addition of Coordinating or Principal Investigator Form

        		 1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        5. CV of the new CPI/PI

        1x e-copy

        6. GCP Certificate of the new CPI/PI

        		  

        1x e-copy

        7. Letter specifying dates of the temporary change to PI

        		  

        1x e-copy

        Updated Participant Facing Documents

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy
        3. HREC Amendment Approval
        		  

        1x e-copy

        4. Updated patient-facing documents

        		  

        1x e-copy

        5. Tracked Changes to the patient-facing documents

        		  

        1x e-copy

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

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy
        3. HREC Amendment Approval
        		  

        1x e-copy

        4. Updated Protocol/ Investigator Brochure – including updated version numbers and dates

                 		  

        1x e-copy

        5. Tracked Changes of the Protocol/Investigator Brochure

        		  

        1x e-copy

        6. Summary of Changes

        Note* An updated PICF will be required if participant procedures (including their data) have changed.

        		  

        1x e-copy

        All Other Changes (Administrative)

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy
        3. HREC Amendment Approval  

        1x e-copy

        4. Documents requiring review

        		  

        1x e-copy

        Updated Participant Information and Consent Form (PICF) 

        1. Amendment Request Form

        		  

        1x e-copy

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

        		  

        1x e-copy
        3. HREC Amendment Approval  

        1x e-copy

        4. Updated Participant Information and Consent Form (PICF) – including updated version numbers and dates

        		  

        1x e-copy

        5. Tracked Changes of the PICF

        1x e-copy

        To learn more about site types - please access the guidance document under Resources for Researchers.

        Addition of Service Site

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

        1. Amendment Request Form

        1x e-copy

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

        		  

        1x e-copy
        3. SVHM Addition of Satellite/Recruitment/Service Site Form  

        1x e-copy

        4. Service Agreement - Only required if Mercy Health (primary site) is utilising an external service site to conduct study activities.

        1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)

        Annual Safety Reports

        Due on the anniversary of study approval

        • For clinical trials involving an Investigational Medicinal Product (IMP) or investigational medical device
        • The completion and submission of an annual safety report is part of the conditions of ethical approval for all projects.
        • 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 & NCTGF requirements

        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.
        • Development Safety Update Reports (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.

        National Statement 5.4.3 (a) requires reports to be received at least annually.

        • 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 6987 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 the HREC and Mercy Health is 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 Mercy Health is 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

        *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 (CTA) 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 HREC requires site principal investigators (or their delegates) to report all related SAEs, SUSARs, and USADEs occurring in participants at Mercy Health, SVPH, and 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 Mercy Health 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 Mercy Health must be reported by the site PI to the research office.

        *If Mercy Health is nominated as the trial sponsor, Mercy Health will assume the Sponsor responsibility and abide by the above SAE reporting timeline. Tthe PI must complete a Mercy Health RiskMan report.

        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 Mercy Health, SVHM or SVPH.

        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. The HREC will not require the Sponsor to submit the SUSARs except for participants that involves Mercy Health, SVHM and SVPH.

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

        SVHM HREC will not require SUSARs and six monthly line listings to be submitted for sites other than Mercy Health, SVHM and SVPH.

        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.

        NHMRC 2018 Update

        The NHMRC has introduced a new document 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 Breaches vs. Non-Serious Breaches

        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.

        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.

        Case Study Reports

        A case study report is an article that describes a particular patient’s diagnosis and treatment plan. Often, a case study is used for the description of an unusual diagnosis or complications in treatment.

        Process of Review

        The Research Governance Unit (RGU) will be reviewing applications for case study reports.

        Once reviewed, a formal letter of approval will be issued. The RGU will endeavour to have a response to your application in approximately 7-10 business days.

        Please submit all Case Study Report applications to research.ethics@svhm.org.au

        • There are no closing dates for Case Study reports
        • ONLY ELECTRONIC COPIES are required. Please DO NOT submit hard copies to our office.

        Please ensure the following documents are completed upon submitting to research.ethics@svhm.org.au

        Document Instructions
        1. Case Study Report

        Please submit your case study abstract using our template as a guide
        2. CV of Researcher(s)

        Please submit CVs of all researchers involved in the Case Study Report
        3. Consent Form

        Please use the template provided here
        4. Support from Head of Department

        Please provide either a letter of support from Head of Department, or Chief Medical Officer if the Head of Department are directly involved in the case report.

        *Please note: if the Head of Department/Chief Medical Officer signs the Case Study Report document, a separate letter is not required.

        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

        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 

        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 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 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. Non-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        		 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

        Quality Assurance and Internal Audits

        The Quality Assurance and Internal Audit processes are essential for ensuring compliance and quality in all research activities.

        For more information, please contact quality.assurance@svhm.org.au

        • Regular audits are conducted to ensure adherence to research protocols and guidelines.
        • Feedback and recommendations are provided to researchers to improve research practices.

         

        Please submit all required documentation to the Quality Assurance Office.

        Document Instructions
        1. Audit Report

        Submit the completed audit report.
        2. Corrective Actions

        Include details of corrective actions taken in response to audit findings.

         

        Please submit all QA applications to qisubmissions@svha.org.au

        • There are no closing dates for QA activities.

        • The use of ERM is not required for QA activities.

        • ONLY ELECTRONIC SUBMISSIONS will be accepted for QA activities.

        Please ensure the following documents are completed upon submitting to QA (qisubmissions@svha.org.au):

        All necessary documents can be found in downloadable form by clicking here.

        1. QA Cover Sheet

        2. Quality Assurance/Audit Application Form

        Electronic signature is accepted for this form

        3. QA Participant Information/Consent Form (PICF) – if applicable

        4. Participant Facing Documents - if applicable

        		 Such as surveys, questionnaires, etc.

        5. Fee Form – if applicable

        Required for all QA activities that are intended to be published

         Amendments are required for any change to the approved project, including changes to the research plan, data collection, or change of investigators.

        Please ensure the following documents are completed upon submitting amendments to QA (qisubmissions@svha.org.au):

        All necessary documents can be found in downloadable form by clicking here.

        1. QA Cover Sheet

        Please complete for any changes to the activity including:

        • Request for extension of the project
        • Addition of sites

        2. Updated Documents – if applicable

        A final report for QA projects will be due by the completion date proposed by the investigator on the QA application form. 

        The completion and submission of a final report is part of the conditions of approval for all projects. If the project has not been completed by the chosen date, please inform the Research Governance Unit.

        Please submit QA final/progress reports to qisubmissions@svha.org.au using the following templates:

        • QA Cover Sheet (if your study is continuing past the proposed completion date)

        • Project Final Report (when your study has been completed) - this should be the finalised document created as part of your QA activity. This can be in whatever form your QA results are in (eg. PowerPoint Presentation, Poster, Flyer, Journal Article, etc.)

        Please include “Final/Progress Report” and your QA study number in the email subject.