Human Research Ethics Committee

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:

   • Submitting a New Governance Only Application (Ethics Approved by an External HREC)
   • Completing Governance Application after SVHM HREC Approval
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).

1. Cover Letter and Checklist - Governance

1x e-copy

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

1x e-copy

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

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

Local HREC Office Contact

*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)

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

SVHM Details for Use When Completing the Form:

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

• 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.

1. Amendment Request Form

1x e-copy

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

1x e-copy

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

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

1. Amendment Request Form

1x e-copy

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

1x e-copy

1x e-copy

4. Change/Addition of Coordinating or Principal Investigator Form

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

1. Changing 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

1. Amendment Request Form

1x e-copy

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

1x e-copy

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

1. Amendment Request Form

1x e-copy

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

1x e-copy

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

1. Amendment Request Form

1x e-copy

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

1x e-copy

1x e-copy

4. Updated patient-facing documents

1x e-copy

5. Tracked Changes to the patient-facing documents

1x e-copy

1. Amendment Request Form

1x e-copy

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

1x e-copy

1x e-copy

4. Documents requiring review

1x e-copy

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

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.

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

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.

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 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:

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

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