Human Research Ethics Committee

The St Vincent's Hospital Melbourne Human Research Ethics Committee (HREC) is fully constituted and operates in accordance with the NHMRC National Statement on Ethical Conduct in Human Research (2007), including all updates.

For any questions regarding submission, please contact the Research Governance Unit on: 

Ph: 03 9231 6970 or email: research.ethics@svhm.org.au

 

As of Q3 2022, SVHM deployed a new ethics review management system called St Vincent’s Application for Governance and Ethics (SAGE). SAGE aims to significantly assist the timely and efficient ethical and governance review of new and existing studies, by providing a one-stop portal for new applications, amendments, and other project updates.  

Going forward, researchers are encouraged to use SAGE for all ethics/governance submissions (except QA projects). The system will replace the existing ethics & governance submission/management process after a short grace period.

Scroll further below for details on ethics/governance application and amendment submission for a High-Risk Research Study. Quick reference guides on how to navigate SAGE is available here.

 

Committee Information

The HREC reviews studies such as:

  • Non-interventional
  • Qualitative
  • Laboratory or basic science
  • Observational studies
  • Clinical research involving drugs, 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.

HREC provides ethical review for studies to be conducted at the following sites:

  • St Vincent's Hospital, Fitzroy campus
  • St George's, Kew
  • Caritas Christi campus
  • Prague House campus
  • Cambridge House
  • DePaul House
  • St Vincent's Private Hospital - a separate governance application will need to be made to SVPHM. Please contact us for more information
  • Any other site that does not have access to an institutional HREC

 

 

HREC Meeting Dates

The closing dates only apply to NEW HIGH RISK ETHICS APPLICATIONS. All other submissions are not reviewed during the HREC Meeting, and may be submitted outside the RGU closing dates, including: 

  • Governance submission for high-risk studies
  • Ethics submission for low-risk studies
  • Governance submission for low-risk studies
  • Quality Assurance
  • Amendment Requests
 

 

SVHM Site-Specific Information

Chief Principal Investigator / Principal Investigator Responsibilities in Trials

Important Notices

2022 Changes

 SAGE Implementation

St Vincent’s Hospital Melbourne is implementing a new ethics review management system called St Vincent’s Application for Governance and Ethics (SAGE). SAGE aims to significantly assist the timely and efficient ethical and governance review of new and existing studies, by providing a one-stop portal for new applications, amendments, and other project updates. 

As of 20th May, researchers are encouraged to use SAGE for all ethics/governance submissions going forward. The system will replace the existing ethics/governance submission process after a short grace period.

Please see the FAQ sheet and SAGE Resources for more information.

 Addition of Clinical Trials Alerts on PAS for ALL Interventional Clinical Participants

 As of 4th April 2022, a new generic Clinical Trials Alert has been added to the Patient Administration System (PAS) to ensure all interventional clinical trial participants are flagged on the hospital system. 

This policy is aligned with the National Clinical Trials Governance Framework (NCTGF) which has been introduced as part of the national hospital standards and accreditation process. As part of this, we need to improve our ability to rapidly identify all participants in interventional clinical trials across the hospital and outpatient setting. This is important for patient/participant safety when they present to the hospital or health service for any episode of clinical care.

Each Department and their research staff will be responsible for adding the Clinical Trial Alert for each participant on the SVHM PAS when they are recruited to a study AND removing the alert when the participant completes the study, including any follow-up period.  Please note that when the Clinical Trial Alert is removed at study completion, there will still be a past alert visible on the PAS system.

Please refer to Addition of Research Alert on PAS for more information. A quick guide is also available on our website.

The RGU will commence auditing the Clinical Trial Alerts on PAS from May 2022.

Onsite Monitoring Guidelines

 As of 25th March 2022, SVHM is now allowing Onsite Monitoring. Remote Monitoring is now optional, the Onsite Monitoring Application Form is no longer applicable. 

However, in line with the SVHM’s Guidance to reduce COVID-19 Exposure (available on the intranet), we strongly recommend the usage of tele/videoconferencing whenever practicable and possible. Updated Onsite-Monitoring guidelines can be found on Resources for Researchers.

Face to face meeting participants must:

  • Not visit if unwell, and complete the COVID19 attestation online upon arrival here.
  • Wear masks. If meeting is under 4 hours and not in a clinical area surgical masks can be worn, otherwise participants to wear N95 masks for the duration of the meeting.
  • Check room size and maximum number of people that will fit with 1.5m spacing.
  • Limit the meeting time by adhering to agenda and the scheduled finish time.

Should you choose to conduct remote monitoring, the Remote Source Data Monitoring Guidelines (2020) are still applicable. The study team must notify the RGU prior to the Interim Monitoring Visit that this is the method of remote monitoring they intend to use.

 Breach Reporting Guidelines

 As of 25th March 2022, SVHM RGU has updated our Breach Reporting Guidelines (2022), detailing non-serious breach, reportable vs non-reportable, and serious breach.

More definitions and examples of these breaches, and when and how to report them, can be found on Resources for Researchers.

2021 Changes

 Contract Submission via DocuSign & Adobe Sign  As of 16th November 2021, all submissions containing contracts that have been sent via DocuSign or Adobe Sign must be accompanied by the Contract Submission Form. Please consult the SVHM Digital Signature Guidelines for further information. 
 Change to SVHM HREC Office contact number  

The SVHM HREC Office contact has been updated from 03 9231 2394 to 03 9231 6970. The old number will no longer be in operation as of the 1st of October 2021. Please ensure that this update is reflected in the next amendment submission. There will be no cost associated with this administrative change to the PICF and CTNs.

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

 

 Changes to Fee Structure May 2021

Please be advised that there have been minor changes made to the fee structure as of the 14th of May 2021. Please see the updated Fee Form for reference.

On-Site Monitoring Guidelines  

Monitors must:

Please refer to the Guidelines for more detail.

From April, monitors and CRAs from interstate are allowed to be on-site if they are travelling from the designated green zone. The 'Guidelines for On-Site Monitoring (2021)' still apply. 

2020 Changes

 COVID-19 Guidance Documents
 Alternative Catholic Wording for Studies Where Pregnancy Should Be Avoided

The following additional wording will be accepted on SVHM site-specific PICFs. This wording has been noted by SVHS Bioethics Committee and is acceptable to St Vincent's Hospital HREC:

"Because of the unknown risks of this study medication, it is important that you do not become pregnant during this trial. For legal reasons, the pharmaceutical company requires us to provide you with the following information about methods of avoiding pregnancy. Not all of this information is endorsed by [insert site name] nor reflects its ethical standards as a Catholic hospital. You should discuss with the study doctor and/or your own doctor and ethical advisor an effective way for you to avoid pregnancy that is in keeping with your beliefs and values"

 Transfer of Quality Assurance (QA) to RGU

Quality Assurance (QA) submissions will now be handled by the Research Governance Unit. As of 01 December 2019, all QA/QI submissions will be reviewed and approved by the RGU.

Please visit our Low Risk/Quality Assurance Page for more information.

All new QA submissions should be submitted to: qisubmissions@svha.org.au 

Updates to PICF Contact Information on PICFs

Clinical Contact Person

Position

Patient Liaison Officer at St Vincent’s Hospital Melbourne

Telephone

(03) 9231 1954

Email

PLO@svhm.org.au

 

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

 Responsibility for Submitting Applications, Amendments, and Safety and Annual Reports

 

The Research Governance Unit would like to inform all researchers that for all commercially sponsored studies, it will be the responsibility of the Research Coordinator or Principal Investigator to submit all applications including annual safety and progress report to the Research Governance Unit.

This is to ensure that the research team has oversight of the conduct of the study.

 Good Clinical Practice (GCP) Certificates  

GCP Certificates will need to be submitted when making an Ethics or Governance Application to SVHM RGU for the following study personnel:

  • Multi-Site Submission without SVHM as a study site– GCP Certificate of the Coordinating Principal Investigator only
  • St Vincent’s Hospital Melbourne as a study site–GCP Certificate of the Principal and all Associate Investigators

New Ethics 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. Then complete the submission via SAGE. 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.
  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 your application is valid, the application will proceed to the next HREC meeting - you will receive a notification via email.
  6. 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
  7. Finally you will receive an Ethics approval via email, and the Ethics project will be active on SAGE. 
  8. After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at St Vincent's Hospital Melbourne. Research must not commence until governance authorisation has been granted. 
    See governance requirement below.

We still accept submissions via email (research.ethics@svhm.org.au), but all submissions will be uploaded to SAGE to be processed and reviewed. On the email, please include:

  • Project ID
  • HREC number (if possible)
  • Documents for review (including fee form)
  • Detail regarding the submission (eg. "new ethics submission, new governance submission)

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 

    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.
    Missing documents in the submission will result in ineligible application and review delays.

    1. Cover Letter and Checklist - Ethics

    1x e-copy

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

    1x e-copy

    3. Human Research Ethics Application (HREA) Form

    *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.

    1x e-copy

    4. Victorian Specific Module (VSM)

    1x e-copy

    5. 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

    6. Participant Information and Consent Form (PICF) - Master Vic Interventional Template for Self

    Different templates are available on the Department of Health website. Please use the template(s) that are appropriate for the type of research you are conducting.

    • Non-Interventional
    • Interventional
    • Participant Partner Pregnancy

    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

    Complaints Contact Person

    Position

    Patient Liaison Officer at St Vincent’s Hospital Melbourne

    Telephone

    (03) 9231 1954

    Email

    PLO@svhm.org.au

    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. Protocol or Research Plan

    1x e-copy

    8. Investigator Brochure (IB) – for drug and device studies

     

    1x e-copy

    9. Budget – as per sponsor or institution guidelines

     

    1x e-copy

    10. Patient-Facing Materials

    Such as surveys, brochures, advertisements or questionnaires

     

    1x e-copy

    11. 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)

     12. Contract Submission Form for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign 1x e-copy 

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

    SVHM Details For Use When Completing the Form

    HREC Name:

    St. Vincent’s Hospital Melbourne Human Research Ethics Committee 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:

    St. Vincent’s Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC, 3065

    Approving Authority Officer:

    Dr Megan Robertson, Director of Research

    Contact Number:

    03 9231 6970

    Contact Email:

    Research.ethics@svhm.org.au

     

    1x e-copy

    14. Certificate of Insurance – as applicable

     

    1x e-copy

    15. Investigator Clinical Practice (GCP) Certificates

    GCP Certificates will need to be submitted when making an Ethics or Governance Application to SVHM RGU for the following study personnel:

    • Coordinating Principal Investigator
    • SVHM Principal Investigator
    • SVHM Associate Investigators / Research Coordinators
     

    1x e-copy

    16. Investigator Curriculum Vitae (CVs)

     

    1x e-copy

          

     

    New Governance Applications

    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 St Vincent's Hospital Melbourne. Research must not commence until governance authorisation has been granted. 

    • 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 have a response within 7-10 working days once all necessary paperwork has been submitted

    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 now commence your study on the approved SVHM Site(s).

     

    We still accept submissions via email (research.ethics@svhm.org.au), but all submissions will be uploaded to SAGE  before being processed and reviewed

    Please include the following information in the email and subject:
    • Project ID

    • HREC number (if possible)

    • Documents for review (including fee form)

    • Detail regarding the submission (eg. "new ethics submission, new governance submission)

    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 

    All documents can be found under 'Forms' in the rigNormalht 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. Missing documents in the submission will result in ineligible application and review delays.

    1. Cover Letter and Checklist - Governance

    1x e-copy

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

     

    1x e-copy

    3. HREC Approval Letter  

    1x e-copy

    4. Original Human Research Ethics Application (HREA) Form

    1x e-copy

    5. Site Specific Assessment (SSA) Form

    *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)

     

    1x e-copy

    7. 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 SVHM.
     

    1x e-copy

    8. Participant Information and Consent Form (PICF) - Copy of the HREC Approved PICF 

    Different templates are available on the Department of Health website. Please use the template(s) that are appropriate for the type of research you are conducting.

    • Non-Interventional
    • Interventional
    • Participant Partner Pregnancy

    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

    1x e-copy

    9. Site-Specific Participant Information and Consent Form (PICF) -Based on the Reviewing HREC Approved Master Participant Information and Consent Form

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

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

    Site Specific- [Protocol No.] SVHM Specific PICF [type eg. 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

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

    1x e-copy

    10. Protocol or Research Plan

     

    1x e-copy

    11. Investigator Brochure (IB) – for drug and device studies

     

    1x e-copy

    12. Budget – as per sponsor or institution guidelines

     

    1x e-copy

    13. Patient-Facing Materials

    Such as surveys, brochures, advertisements or questionnaires

     

    1x e-copy

    14. Form of Indemnity - Standard – for 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

    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

    SVHM Details for RCA:

    • Name of Institution: St Vincent's Hospital (Melbourne) Limited
    • Address: 41 Victoria Parade, Fitzroy VIC 3065
    • ABN: 22 052 110 755

    Research Collaboration Agreement (RCA) with SVHM details inserted can be found on our 'Forms' Page here.

    Please note that only the Director of Research and the Executive 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 1x e-copy
     

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

    SVHM Details for Use When Completing the Form:

    HREC Name:

    St. Vincent’s Hospital Melbourne Human Research Ethics Committee 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:

    St. Vincent’s Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC, 3065

    Approving Authority Officer:

    Dr Megan Robertson, Director of Research

    Contact Number:

    03 9231 6970

    Contact Email:

    Research.ethics@svhm.org.au


     

    1x e-copy

    19. Certificate of Insurance – as applicable

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

     

    1x e-copy

    20. Investigator Good Clinical Practice (GCP) Certificates

    GCP Certificates will need to be submitted when making an Ethics or Governance Application to SVHM RGU for the following study personnel:

    • Coordinating Principal Investigator
    • SVHM Principal Investigator
    • SVHM Associate Investigators / Research Coordinators 
     

    1x e-copy

    21. Investigator Curriculum Vitae (CVs) 

     

    1x e-copy

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

    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 7-10 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 ChangeUpdate 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:

    • For a SVHM-approved ethics project where SVHM is also the 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 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 SVHM HREC number in the email.

    We only accept urgent amendments via email, please include the following information in the email and subject:

    • Project ID
    • HREC number (if possible)
    • Documents for review (including fee form)
    • detail regarding the submission (eg. "amendment protocol and PICF")

    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 
    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 SVHM 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 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

     

    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


    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


    Addition of a Full Site

    Governance authorisation required for a SVHM 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


    Addition of Satellite 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

    3SVHM 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

    3SVHM 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
    1x e-copy

    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 SVHM (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)


    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

          

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

    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 7-10 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 three 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 SVHM is also the 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 SVHM HREC number in the email.

     

    We only accept urgent amendments via email, please include the following information in the email and subject:

    • Project ID
    • HREC number (if possible)
    • Documents for review (including fee form)
    • detail regarding the submission (eg. "amendment (protocol and PICF)

    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 

    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 SVHM 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 SVHM 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


    Changing Members of a Research Team (Associate Investigator or Research Coordinator)

    1Changing Members of a Research Team Form

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

    2. CV of the new Research Team Member

    1x e-copy

    3. GCP Certificate of the new Research Team Member

    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

     

    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


    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


    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

    Annual Reporting 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.
    • 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

    • Once signed by the Sponsor/CRO, or the Coordinating Principal Investigator (CPI) for a multi-site project, or the Principal Investigator (PI) for a single-site project, forward electronically to the RGU.
    • Please submit Annual Safety Reports using the Annual Safety Report Form.
    • DSURs may serve as the annual safety report, but are not required. They must be accompanied with a completed Annual Safety Report Template.
    • ONLY E-COPIES are required for submission. Please submit to: SAE.ClinicalTrial@svha.org.au

    Annual Project/Progress Reports

    Due on 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

    • The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
    • For further information, please contact Research Integrity and Compliance Assistance on 03 9231 6987 or email: svhm.ResearchAnnualR@svha.org.au

    Submitting Annual Reports

    • Once signed by the Sponsor/CRO, or the Coordinating Principal Investigator (CPI) for a multi-site project, or the Principal Investigator (PI) for a single-site project, forward electronically to the RGU.
    • ONLY E-COPIES are required for submission. Please submit to: svhm.ResearchAnnualR@svha.org.au

    All annual reports should be submitted using one or more of the following templates as applicable:

    Progress Report – Project Form

    *Completed by the Sponsor

    HREC

    Due 01 May

    Project Final Report/Site Closure Report

    *Completed by the Sponsor

    HREC/

    RGO

    Due

    • Upon completion of the research project (single-site or multi-site)

    -or-

    • Upon site closure (multi-site project)

    Progress Report – Site Form

    *Completed by the Principal Investigator

    RGO

    Due 01 May

    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 using the Safety Report Form.
    • ONLY E-COPIES are required for Safety Reports and should be submitted electronically to sae.clinicaltrial@svha.org.au, with the subject header >eg: HREC-D xxx/xx Patient ID xxxxx – (causality)
    • All safety reports for St. Vincent's Hospital Melbourne RGU must be signed by the Chief Investigator or the Sponsor.

    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:

    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 that involve St. Vincent’s participants need to be reported to SVHM HREC

    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 that involve St. Vincent’s participants need to be reported to SVHM HREC

    *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. The HREC will not require the Sponsor to submit the SUSARs except for participants that involves St Vincent's Hospital, Melbourne participants.

    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 St. Vincent's Hopsital Melbourne (SVHM).

    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 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 within 3 Months.

     

     

    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
    • ONLY E-COPIES are required for breaches
    • For breaches concerning SVHM HREC/RGO please submit to: 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
    • For breaches concerning SVHM RGO please submit to: research.ethics@svhm.org.au

    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 should be reported to the RGO within 14 calendar days of confirming a non-serious breach has occurred and provide follow-up reports when required.

    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 hard copy

    1x e-copy

    2. Fee Formplease include remittance advice when paying with EFT

    1x hard copy

    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 signed original hard copy

    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 hard copy

    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 original hard copy

    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 signed original hard copy

    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. Nnon-randomised controlled trials
    4. Individual case studies
    5. Consensus opinion of specialist colleges and societies

    1x hard copy

    1x e-copy

    8. Global Regulatory Statusif available

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

    1x hard copy

    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 hard copy

    1x e-copy

    10. Current Prescriber CV

    1x hard 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

    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