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.
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All submission are now completed and managed via SAGE, please refer to SAGE Resource Pack for the types of submission forms on SAGE.
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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
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Name
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St. Vincent’s Hospital (Melbourne) Human Research Ethics Committee
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Position
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HREC Executive Officer
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Telephone
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(03) 9231 6970
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Email
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Research.ethics@svhm.org.au
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| 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.
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| 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.
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2020 Changes
| COVID-19 Guidance Documents |
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| 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"
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| 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
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Updates to PICF Contact Information on PICFs
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Clinical Contact Person
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Position
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Patient Liaison Officer at St Vincent’s Hospital Melbourne
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Telephone
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(03) 9231 1954
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Email
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PLO@svhm.org.au
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Reviewing HREC Approving this Research and HREC Executive Officer Details
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Reviewing HREC Name
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St. Vincent’s Hospital Melbourne HREC
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Position
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HREC Executive Officer
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Telephone
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(03) 9231 6970
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Email
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Research.ethics@svhm.org.au
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*Please note: these details must appear exactly as it is shown below
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| 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.
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| 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
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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
- Please make sure to complete the Human Research Ethics Application (HREA) form on ERM
- 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.
- You will receive a confirmation email that your study has been successfully submitted.
- If your application is ineligible, you will receive a notification via email, please provide requested items via SAGE (Responding to an Ineligible Application)
- If your application is valid, the application will proceed to the next HREC meeting - you will receive a notification via email.
- 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
- Finally you will receive an Ethics approval via email, and the Ethics project will be active on SAGE.
- 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.
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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. Missing documents in the submission will result in ineligible application and review delays.
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1. Cover Letter and Checklist - Ethics – Mandatory
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1x e-copy
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2. Fee Form – Mandatory
Please include remittance advice when paying with EFT
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1x e-copy
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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 SVHM is the lead site, please include the following information within the sponsor section of the HREA:
Sponsor name: St Vincent's Hospital Melbourne
Sponsor contact details: Dr Megan Robertson, 41 Victoria Parade, Fitzroy, VIC, 3065
Phone: 03 9231 6970. Email: research.ethics@svha.org.au
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1x e-copy
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4. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved
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1x e-copy
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5. Protocol or Research Plan – Mandatory
Protocol must have a footer that includes document name, version number and date
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1x e-copy
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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. 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
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Position
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Patient Liaison Officer at St Vincent’s Hospital Melbourne
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Telephone
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(03) 9231 1954
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Email
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PLO@svhm.org.au
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Reviewing HREC Approving this Research and HREC Executive Officer Details
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Reviewing HREC Name
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St. Vincent’s Hospital Melbourne HREC
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Position
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HREC Executive Officer
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Telephone
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(03) 9231 6970
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Email
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Research.ethics@svhm.org.au
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*Please note: these details must appear exactly as it is shown below
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1 x e-copy
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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.
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1x e-copy |
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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.
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1x e-copy |
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9. Investigator Brochure (IB) – for studies involving drugs and/or devices
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1x e-copy
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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)
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| 11. Contract Submission Form –for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign |
1x e-copy |
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12. Clinical Trial Notification Form (CTN) – for use of unapproved therapeutic goods under the CTN scheme
SVHM Details For Use When Completing the Form
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HREC Name:
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St. Vincent’s Hospital Melbourne HREC
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| HREC Code: |
EC00343 |
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HREC Contact Officer:
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Dr Tam Nguyen, Executive Officer of Research
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HREC Contact Number:
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03 9231 6970
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HREC Contact Email:
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Research.ethics@svhm.org.au
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Approving Authority:
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St. Vincent’s Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC, 3065
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Approving Authority Officer:
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Dr Megan Robertson, Director of Research
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Contact Number:
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03 9231 6970
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Contact Email:
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Research.ethics@svhm.org.au
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1x e-copy
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13. Certificate of Insurance – for all commercially sponsored clinical trials
What is Required? - Insurance for Clinical Trials Information and Guide (2020)
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1x e-copy
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14. Investigator Clinical Practice (GCP) Certificates – Mandatory
Provide a current and valid GCP Certificates for the following study personnel:
- For Multi-site study - Coordinating Principal Investigator
- For Single-site study - Principal Investigator
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1x e-copy
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15. Investigator Curriculum Vitae (CVs) – Mandatory
Provide a Curriculum Vitae for the following study personnel:
- For Multi-site study - Coordinating Principal Investigator and Principal Investigators of each site
- For Single-site study - Principal Investigator
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1x e-copy
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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 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
- Please make sure to complete a Site Specific Assessment (SSA) form on ERM
- Then complete the Governance application by submitting via SAGE,
See Quick Reference Guide here. Videos tutorials available below:
- You will receive a confirmation email that your study has been successfully submitted.
- If your application is ineligible, you will receive a notification via email, please provide requested items via SAGE (Responding to an Ineligible Application)
- If there are any queries, you will then need to submit your response via SAGE - Responding to Letter of Query
- Finally, you will receive a final governance approval via email, and the Site project will be active on SAGE.
- You can now commence your study on the approved SVHM Site(s).
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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 right hand side bar. Please click here to be redirected. Missing documents in the submission will result in ineligible application and review delays.
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1. Cover Letter and Checklist - Governance – Mandatory
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1x e-copy
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2. Fee Form – Mandatory
Please include remittance advice when paying with EFT
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1x e-copy
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3. HREC Approval Letter (including any amendment approval) – Mandatory
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1x e-copy |
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4. Original Human Research Ethics Application (HREA) Form – Mandatory
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1x e-copy
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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.
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1x e-copy
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6. Victorian Specific Module (VSM) – Mandatory
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1x e-copy |
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7. Protocol or Research Plan – Mandatory
Submit the original Protocol approved by the reviewing HREC
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1x e-copy |
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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.
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1x e-copy |
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9. Site-Specific Participant Information and Consent Form (PICF) – if participants are enrolled in the study
Create the SVHM Specific Participant Information and Consent Form based on the Reviewing HREC Approved Master PICF.
Both tracked and clean SVHM Specific Participant Information and Consent Form Version are required for submission.
SVHM 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.] SVHM Specific PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy
Complaints Contact Person
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Position
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Patient Liaison Officer at St Vincent’s Hospital Melbourne
|
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Telephone
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(03) 9231 1954
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Email
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PLO@svhm.org.au
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Local HREC Office Contact
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Name
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St. Vincent’s Hospital (Melbourne) Human Research Ethics Committee
|
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Position
|
HREC Executive Officer
|
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Telephone
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(03) 9231 6970
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Email
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Research.ethics@svhm.org.au
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*Please note: these details must appear exactly as it is shown below
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1x e-copy |
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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.
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1x e-copy |
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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 SVHM.
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1x e-copy
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12. Investigator Brochure (IB) – for studies involving drugs and/or device
Submit the original Investigator Brochure approved by the reviewing HREC.
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1x e-copy
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13. Budget – as per sponsor or institution guidelines
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1x e-copy |
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14. Form of Indemnity - Standard – for all commercially sponsored trials where SVHM is providing premises for the conduct of the study
SVHM Indemnified Party Details
St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755
What is Required? - Insurance for Clinical Trials Information and Guide (2020)
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1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
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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.
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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)
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17. Contract Submission Form – for all submissions that have forwarded a legal agreement via DocuSign/Adobe Sign
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1x e-copy |
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18. Clinical Trial Notification Form (CTN) – for use of unapproved therapeutic goods under the CTN scheme
SVHM Details for Use When Completing the Form:
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HREC Name:
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St. Vincent’s Hospital Melbourne Human Research Ethics Committee
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| HREC Code: |
EC00343 |
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HREC Contact Officer:
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Dr Tam Nguyen, Deputy Director of Research
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HREC Contact Number:
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03 9231 6970
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HREC Contact Email:
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Research.ethics@svhm.org.au
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Approving Authority:
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St. Vincent’s Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, VIC, 3065
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Approving Authority Officer:
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Dr Megan Robertson, Director of Research
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Contact Number:
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03 9231 6970
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Contact Email:
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Research.ethics@svhm.org.au
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1x e-copy
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19. Certificate of Insurance – for all commercially sponsored trials
Submit the original Certificate of Insurance approved by the reviewing HREC.
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1x e-copy
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20. Investigator Good Clinical Practice (GCP) Certificates – Mandatory
Provide a current and valid GCP Certificates for the following study personnel:
- SVHM Principal Investigator
- SVHM Associate Investigators
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1x e-copy
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21. Investigator Curriculum Vitae (CVs) – Mandatory
Provide a Curriculum Vitae for the following study personnel:
- SVHM Principal Investigator
- SVHM Associate Investigators
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1x e-copy
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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.
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To Submit an Amendment to an Ethics Project:
- Permanent CPI/PI Change (more than 6 months)
- General Amendment (temporary CPI/PI Change, Update in Protocol/IB, PICF, Participant Facing Documents (PFD), and all other administrative changes)
- 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.
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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)
General Amendment: Change of Principal Investigator (Temporary - less than 6 months)
General Amendment: Updated Protocol and/or Investigator's Brochure (IB)
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Updated Protocol/ Investigator Brochure – including updated version numbers and dates
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1x e-copy
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4. Tracked Changes of the Protocol/Investigator Brochure
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1x e-copy
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5. Summary of Changes
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1x e-copy
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General Amendment: Updated Participant Information and Consent Form (PICF)
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Updated Participant Information and Consent Form (PICF) – including updated version numbers and dates
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1x e-copy
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4. Tracked Changes of the PICF
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1x e-copy
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General Amendment: Updated Participant Facing Documents
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Updated patient-facing documents - including updated version numbers and dates
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1x e-copy
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4. Tracked Changes to the patient-facing documents
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1x e-copy
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Addition of a Full Site
Governance authorisation required for a SVHM site after amendment is approved before study commencement
Addition of Satellite Site
Please click here to view guideline document for what qualifies under this category of site addition.
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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| 3. SVHM Addition of Satellite/Recruitment/Service Site Form |
1x e-copy
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| 4. Letter of Support from Site |
1x e-copy |
| 5. CV & GCP Certificate for PI/AI responsible at the satellite site |
1x e-copy |
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6. Form of Indemnity - HREC Review Only - for commercially sponsored studies
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1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
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| 7. Insurance Certificate - for commercially sponsored studies |
1x e-copy |
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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
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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
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1x e-copy |
Please click here to view guideline document for what qualifies under this category of site addition.
Please click here to view guideline document for what qualifies under this category of site addition.
All Other Changes (Administrative)
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
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1x e-copy
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3. Documents requiring review
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1x e-copy
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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:
- Permanent PI Change (more than 6 months)
- 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 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 SVHM HREC number in the email.
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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.
Change of SVHM Principal Investigator (Permanent)
Change of SVHM Principal Investigator (Temporary - less than 6 months)
Changing Members of a Research Team (Associate Investigator or Research Coordinator)
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1. Changing Members of a Research Team Form
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1x e-copy (either scanned wet ink signature or DocuSign/Adobe Sign signature)
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2. CV of the new Research Team Member
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1x e-copy
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3. GCP Certificate of the new Research Team Member
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1x e-copy
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Updated Protocol and/or Investigator's Brochure (IB)
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
|
1x e-copy
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3. HREC Amendment Approval
|
1x e-copy
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4. Updated Protocol/ Investigator Brochure – including updated version numbers and dates
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1x e-copy
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5. Tracked Changes of the Protocol/Investigator Brochure
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1x e-copy
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6. Summary of Changes
|
1x e-copy
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Updated Participant Information and Consent Form (PICF)
|
1. Amendment Request Form
|
1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
|
1x e-copy
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| 3. HREC Amendment Approval |
1x e-copy
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4. Updated Participant Information and Consent Form (PICF) – including updated version numbers and dates
|
1x e-copy
|
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5. Tracked Changes of the PICF
|
1x e-copy
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Updated Participant Facing Documents
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1. Amendment Request Form
|
1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
|
1x e-copy
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3. HREC Amendment Approval
|
1x e-copy
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4. Updated patient-facing documents
|
1x e-copy
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5. Tracked Changes to the patient-facing documents
|
1x e-copy
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All Other Changes (Administrative)
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1. Amendment Request Form
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1x e-copy
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2. Fee Form - please include remittance advice when paying with EFT
|
1x e-copy
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| 3. HREC Amendment Approval |
1x e-copy
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4. Documents requiring review
|
1x e-copy
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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 (ASR)
- Please submit Annual Safety Reports (ASR) via SAGE. See How to submit an Annual Safety Report (ASR)
- The sponsor is responsible for reporting to the reviewing HREC, in accordance with Safety Monitoring and Reporting
in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016). ONLY the Sponsor or CPI can sign-off and submit the
ASR Form.
- DSURs may serve as the annual safety report, but are not required. They can be uploaded to the Annual Safety Report Form on SAGE.
Annual Project/Progress Reports
Due 01 May - Annual Reports for projects that have been approved in January to April in any year do not need to be submitted until 01 May the following year.
Failure to submit progress reports within 45 days following the 01 May submission deadline may lead to a suspension of the ethical approval for the study.
- 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 both the HREC and the only participating site |
Site Report/Closure Form (RGO) |
Milestone tab under the SSA Project |
PI only |
Both Ethics and Governance project
- Multi-site study where SVHM is the HREC and one of the participating sites |
Both HREC and RGO report forms are required |
Milestone tab under the SVH Project for HREC Form;
and the SSA Project for each RGO Form/s |
HREC Report:
- Investigator-initiated study: CPI
- Commercially-sponsored study: Sponsor
RGO Report: PI only
|
Ethics project with a closure of an external site
- Closure of a non-SVHM RGO site approved under SVHM HREC |
External Site Closure Form (HREC) |
Form tab under the SVH Project
How to submit an external site closure form |
- Investigator-initiated study: CPI
- Commercially-sponsored study: Sponsor
|
*Annual Safety Report Information in Header above, under "Annual Reporting Requirements"
For more details on safety reporting please view the "NHMRC Guide on Safety monitoring and reporting in clinical trials involving therapeutic goods" on our Resources page.
This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.
Submitting Safety Reports
- Please submit Safety Reports via SAGE. See SAGE Resource Pack for instructions.
- All safety reports for St. Vincent's Hospital Melbourne RGU must be signed by the Chief Investigator or the Sponsor.
IMPORTANT: Please note a serious breach report must be submitted to HREC for all safety reports that were not reported within the required timeframe, as they may pose a risk to the study participant.
Definitions
|
Adverse Reaction
|
Any untoward and unintended response to an investigational medicinal product related to any dose administered.
|
|
Serious Adverse Event (SAE)
|
Any adverse event/adverse reaction that results in:
- Death,
- Life-threatening, requires hospitalisation or prolongation of existing hospitalisation,
- Results in persistent or significant disability or incapacity
- Congenital anomaly or birth defect
|
|
Suspected Unexpected Serious Adverse Event (SUSAR)
|
An adverse reaction that is both serious and unexpected. It is also not consistent with the investigator brochure or product information.
|
|
Significant Safety Issue (SSI)
|
A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.A SSI can be a SAE that is associated with the study (Definitely related, Probably related and Possibly related).
- A serious adverse event that could be associated with the trial procedures and that requires modification of the conduct of the trial
- A hazard to the patient population, such as lack of efficacy of an IMP used for the treatment of a life-threatening disease.
- A major safety finding from a newly completed animal study (such as carcinogenicity)
- A temporary halt/termination of a trial for safety reasons
Recommendations of the Data Safety Monitoring Board, where relevant for the safety of participants, such as an increase in frequency or severity of an expected adverse reaction
- Single case events (e.g. toxic epidermal necrolysis, agranulocytosis, hepatic failure) that lead to an urgent safety measure.
|
|
Urgent Safety Measure (USM)
|
A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety. Note: This type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented before seeking approval from HRECs or institutions.
|
Serious Adverse Events (SAEs)
- In the event of a Serious Adverse Event (SAE) Investigators are required to report to Sponsor within 24 hours of becoming aware of the SAE.
- The sponsor, on becoming aware of the reported SAE made by Investigators, will be required to notify HREC and TGA based on the type of SAE and the associated timeline as described below:
|
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.
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.
|
|
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:
- Obtain HREC Approval or Specialist College endorsement
- Submit an application to TGA
- 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 Form – please 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:
- Product information documents (of equivalent) (if the good is approved by an overseas regulator)
- Randomised controlled trials
- Nnon-randomised controlled trials
- Individual case studies
- Consensus opinion of specialist colleges and societies
|
1x hard copy
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 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
|