Human Research Ethics Committee

The Research Governance Office will be closed from 23 December 2019 to 06 January 2020. Please see submission dates below for new applications during this time period. 

 

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.

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*
  • Any other site that does not have access to an institutional HREC

*Researchers are required to submit a Governance application to St Vincent's Private Hospital once ethics approval has been granted by SVHM HREC.

 

Committee Information

HREC Meeting Dates

 

Please note: The Research Governance Office will be closed from 23 December 2019 to 06 January 2020 

 

Closing Date for Submission

Meeting Date

03 Dec 2019 - Final Meeting for the Year 18 Dec 2019 - Final Meeting for the Year
10 Dec 2019 15 Jan 2020
14 Jan 2020 29 Jan 2020

28 Jan 2020

12 Feb 2020

 

Ethics, Governance and Amendment Submissions

  • Please ensure the SVHM Site-Specific Guidelines for submissions are followed when submitting your application
  • Please ensure standard templates and formatting are used for submissions

Responsibilities of the Chief Principal Investigator (CPI),  Principal Investigator and Sponsor

Collation of Documents

  • Please ensure applications are collated prior to submission to allow distribution to HREC members
  • The original copy of each document should be clipped together in one bundle using a bulldog clip or similar. Please mark original documents as "original" in the top right hand corner as these will be kept on file.
  • Remaining 2 copies should be collated in bundles, with each including a single copy of all documents including the application form/s, the Participant Information and Consent Form(s) and any other documents required for submission. These documents must also be clipped together using a bulldog clip or similar. This will ensure each HREC member receives a copy of each document.

    Hard Copies of Applications must be delivered to:

    Office Location: Level 5, Aikenhead Building, Building E

    41 Victoria Parade, Fitzroy, 3065

     

    Mailing Address: St. Vincent’s Hospital Melbourne

    Research Governance Unit (RGU), PO Box 2900

    Fitzroy, 3065

    Electronic Copies of Applications must be delivered to:

    E-Mail: Research.Ethics@svhm.org.au

    Subject: Project ID# and CPI Name

Important Notices

2019 Changes

 

 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 RGU Forms

Updates to PICF Contact Information on PICFs

Clinical Contact Person

Position

Patient Liaison Officer at St Vincent’s Hospital Melbourne

Telephone

(03) 9231 1945

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 2394

Email

Research.ethics@svhm.org.au

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

SVHM Site Specific Guidelines Update

The document can be located under the New Ethics Application Tab. Please note the Patient Liaison Officer number has changed, please refer to the updated site-specific guidelines for the new number.The RGU advises all researchers/sponsor to read the document before completing an ethics submission.

Amendment Hard Copy Documents

The RGU will no longer require a copy in full for amendments to:

  • Protocols
  • Investigator Brochures

Please only provide a hard copy of the front page of these documents when amending them

 


2018 Changes

 

Electronic Signature Update

Electronic signature is now accepted by the SVHM Research Governance Unit.

Wet ink signature will still be mandatory for the following documents:

  • Indemnities
  • Clinical Trial Research Agreements
  • Collaboration Agreements
  • All legal documents

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.

Ethics Review Manager (ERM)

On the 16 July 2018, Victoria transitioned from Online Forms to the new ERM system for Ethics and Governance submissions.

SVHM RGU understands that ERM is a new system and Researchers may be encountering issues performing submissions (for Ethics and Governance Applications and Amendments) to the RGU office.

The RGU Office would like to inform Researchers that if you encounter issues with submissions via ERM, you may submit your application via the alternative method below:

  • Generate a hard copy of the ERM form and scan form
  • Email this scanned copy together with all study documents to research.ethics@svhm.org.au
  • Submit a hard copy of all study documents to the Research Governance Unit.

Please refer to the New Ethics and Governance Tab below for the number of hard copies required.

If researchers continue to encounter issues with the ERM system please contact the ERM IT Helpdesk on:

New Forms

The Research Governance Unit has made changes to the following forms:

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 Applications

Process of Review

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

Ph: 03 9231 2394 or email: research.ethics@svhm.org.au

 

1. Ethics Cover Letter and Checklist

1x hard copy

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

1x hard copy

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

3x hard copies:

  • 1 signed original
  • 2 copies

 

1x e-copy

4. Victorian Specific Module (VSM)

3x hard copies:

  • 1 signed original
  • 2 copies

 

1x e-copy

5. Medical Physicist Letter – if ionising radiation is involved

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.

3x hard copies:

  • 1 signed original
  • 2 copies

 

1x e-copy

6. Master Participant Information and Consent Form (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

Patient Information and Consent Form Contact Information

Clinical Contact Person

Position

Patient Liaison Officer at St Vincent’s Hospital Melbourne

Telephone

(03) 9231 1945

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 2394

Email

Research.ethics@svhm.org.au

 

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

3 x hard copies

1 x e-copy

7. Protocol or Research Plan

2x hard copies

1x e-copy

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

2x hard copies

1x e-copy

9. Budgetas per sponsor or institution guidelines

3x hard copies

1x e-copy

10. Patient-Facing Materials

Such as surveys, brochures, advertisements or questionnaires

3x hard copies

1x e-copy

11. HREC Only Form of Indemnityfor clinical trials

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, Victoria 3065, ABN 22 052 110 755

3x hard copies – all signed originals

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

*Please use the following SVHM details 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 2394

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 2394

Contact Email:

Research.ethics@svhm.org.au

1x hard copy

1x e-copy

 

 

 

 

13. Certificate of Insuranceas applicable

1x hard copy

1x e-copy

14. 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:

  • 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

1x hard copy

1x e-copy

15. Investigator Curriculum Vitae (CVs)

1x hard copy

1x e-copy

 

 

New Governance Applications

Process of Review

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

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

Ph: 03 9231 2394 or email: research.ethics@svhm.org.au

 

1. Governance Cover Letter and Checklist

1x hard copy

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

1x hard copy

1x e-copy

3. HREC Approval Letter

1x hard copy

1x e-copy

4. Original Human Research Ethics Application (HREA) Form

1x signed original hard copy

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 -ERM User Guide

1x signed original hard copy

1x e-copy

6. Victorian Specific Module (VSM)

1x signed original hard copy

1x e-copy

7. Medical Physicist Letterif ionising radiation is involved

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 signed original hard copy

1x e-copy

8. Reviewing HREC Approved Master PICF 

1x hard copy

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

Patient Information and Consent Form Contact Information

Clinical Contact Person

Position

Patient Liaison Officer at St Vincent’s Hospital Melbourne

Telephone

(03) 9231 1945

Email

PLO@svhm.org.au

 

Local HREC Office Contact (Single Site- Research Governance Officer)

Name

St. Vincent’s Hospital (Melbourne) Human Research Ethics Committee

Position

HREC Executive Officer

Telephone

(03) 9231 2394

Email

Research.ethics@svhm.org.au

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

1x hard copy

1x e-copy

10. Protocol or Research Plan

1x hard copy

1x e-copy

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

1x hard copy

1x e-copy

12. Budgetas per sponsor or institution guidelines

1x hard copy

1x e-copy

13. Patient-Facing Materials

Such as surveys, brochures, advertisements or questionnaires

1x hard copy

1x e-copy

14. Standard Form of Indemnityfor commercially sponsored trials

For clinical trials where SVHM is providing premises for the conduct of the study and/or HREC review:

*SVHM Indemnified Party Details

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

3x hard copies – all signed originals

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

*Please insert following SVHM details in the Research Agreement

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

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.

3x hard copies – all signed originals

 

 

 

 

3x hard copies – all signed originals

17. Certificate of Insuranceas applicable

1x hard copy

1x e-copy

18. Letter of Support from Head of Department

Due to a conflict of interest, any Head of Department that is listed as a Principal Investigator or Associate Investigator on the study CANNOT sign off on the study.

In this instance, a Letter of Support from the Chief Medical Officer is required.

1x hard copy

1x e-copy

19. 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:

  • St Vincent’s Hospital Melbourne as a study site–GCP Certificate of the Principal and all Associate Investigators

1x hard copy

1x e-copy

19. Investigator Curriculum Vitae (CVs)

  • St Vincent’s Hospital Melbourne as a study site– CVs of the Principal and all Associate Investigators

1x hard copy

1x e-copy

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

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

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

Ph: 03 9231 2394 or email: research.ethics@svhm.org.au


Change of Principal Investigator (Permanent)

1. Amendment Request 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. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

4. CV of the new CPI/PI

1x hard copy

1x e-copy

5. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

6. Updated HREC Review Form of Indemnityif commercially sponsored

3x hard copies – all signed originals

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

1x hard copy

1x e-copy

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

3x hard copies – all signed originals

 


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

1. Amendment Request 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. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

4. CV of the new CPI/PI

1x hard copy

1x e-copy

5. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

6. Letter specifying dates of the temporary change to PI

1x hard copy

1x e-copy


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

1. Changing Members of a Research Team Form

1x e-copy

2. CV of the new Research Team Member

1x e-copy

3. GCP Certificate of the new Research Team Memberonly for SVHM employees

1x e-copy


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

1. Amendment Request 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. Updated Protocol/ Investigator Brochureincluding updated version numbers and dates

*Note: only the 1st page is required to be submitted in hard copy

1x hard copy

1x e-copy

4. Tracked Changes of the Protocol/Investigator Brochure

*Note: only the 1st page is required to be submitted in hard copy

1x hard copy

1x e-copy

5. Summary of Changes

1x hard copy

1x e-copy


Updated Participant Information and Consent Form (PICF) 

1. Amendment Request 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. Updated Participant Information and Consent Form (PICF)including updated version numbers and dates

1x hard copy

1x e-copy

4. Tracked Changes of the PICF

1x hard copy

1x e-copy


Updated Participant Facing Documents

1. Amendment Request 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. Updated patient-facing documents

1x hard copy

1x e-copy

4. Tracked Changes to the patient-facing documents

1x hard copy

1x e-copy


Addition of Sites

1. Amendment Request 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. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

4. Site Medical Physicist Reportif ionising radiation is involved

1x hard copy

1x e-copy

5. CV of the new CPI/PI

1x hard copy

1x e-copy

6. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

7. Updated HREC Review Form of Indemnityif commercially sponsored

-or-

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

3x hard copies – all signed originals

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

1x hard copy

1x e-copy

9. Letter of Acknowledgment from Participating Site(s)

1x hard copy

1x e-copy

 


Addition of Satellite/Service Sites

1. Amendment Request 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. SVHM Addition of Satellite/Service Site Form

1x hard copy

1x e-copy

4. Updated HREC Review Form of Indemnityif commercially sponsored

3x hard copies – all signed originals

 


All Other Changes (Administrative)

1. Amendment Request 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. Documents requiring review

1x hard copy

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

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

Ph: 03 9231 2394 or email: research.ethics@svhm.org.au


Change of SVHM Principal Investigator (Permanent)

1. Amendment Request 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. HREC Amendment Approval

1x hard copy

1x e-copy

4. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

5. CV of the new CPI/PI

1x hard copy

1x e-copy

6. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

7. Updated Standard Form of Indemnity – if commercially sponsored

3x hard copies – all signed originals

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

1x hard copy

1x e-copy

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

3x hard copies – all signed originals


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

1. Amendment Request 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. HREC Amendment Approval

1x hard copy

1x e-copy

4. Change/Addition of Coordinating or Principal Investigator Form

1x hard copy

1x e-copy

5. CV of the new CPI/PI

1x hard copy

1x e-copy

6. GCP Certificate of the new CPI/PI

1x hard copy

1x e-copy

7. Letter specifying dates of the temporary change to PI

1x hard copy

1x e-copy


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

1. Changing Members of a Research Team Form

1x e-copy

2. CV of the new Research Team Member

1x e-copy

3. GCP Certificate of the new Research Team Member – only for SVHM employees

1x e-copy


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

1. Amendment Request 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. HREC Amendment Approval

1x hard copy

1x e-copy

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

*Note: only the 1st page is required to be submitted in hard copy

1x hard copy

1x e-copy

5. Tracked Changes of the Protocol/Investigator Brochure

*Note: only the 1st page is required to be submitted in hard copy

1x hard copy

1x e-copy

6. Summary of Changes

1x hard copy

1x e-copy


Updated Participant Information and Consent Form (PICF) 

1. Amendment Request 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. HREC Amendment Approval

1x hard copy

1x e-copy

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

1x hard copy

1x e-copy

5. Tracked Changes of the PICF

1x hard copy

1x e-copy


Updated Participant Facing Documents

1. Amendment Request 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. HREC Amendment Approval

1x hard copy

1x e-copy

4. Updated patient-facing documents

1x hard copy

1x e-copy

5. Tracked Changes to the patient-facing documents

1x hard copy

1x e-copy


All Other Changes (Administrative)

1. Amendment Request 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. HREC Amendment Approval

1x hard copy

1x e-copy 

4. Documents requiring review

1x hard copy

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 Julie Luong on 03 9231 2941 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 Template.
  • 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

  • In 2017 the Research Governance Unit (RGU) implemented a new system for the submission of annual progress reports that will save significant time and resources for research staff and RGU staff.
  • Annual progress reports for research projects will be due on a single date in the year instead of the anniversary of the HREC approval date. The date chosen is the 01 May.
  • The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
  • For further information, please contact Lily Woods, Research Integrity and Compliance Assistance on 03 9231 3924 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: Safety monitoring and reporting in clinical trials involving therapeutic goods.

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

  • The Safety Report Form can be downloaded from the Department of Health website
  • 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 Principal Investigator 

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.

 

Administrative SOPs

Chapter 1. Values and Principles of Ethical Conduct

1.1 - Application of Values and Principles of Ethical Conduct

Chapter 2. Risk, Benefit and Consent

2.1 - Assessment of Risks and Benefits  
2.2 - Obtaining and Honouring Consent
2.3 - Qualifying or Waiving Conditions 

Chapter 3. Ethical Considerations Specific to Research Methods

3.1 - Qualitive Methods
3.2 - Databanks
3.3 - Interventions and Therapies
3.4 - Human Tissue Samples
3.5 - Human Genetics
3.6 - Human Stem Cells         

Chapter 4. Ethical Considerations Specific to Participants

4.1 Ethical Consideration Specific to Participants

Chapter 5. Research Governance and Ethical Review

5.1 - Low Risk Research
5.2 - Composition of the Committee
5.3 - Appointment of HREC Members
5.4 - Induction of New HREC Members
5.5 - Responsibilities of HREC Members
5.6 - Training for HREC Members
5.7 - Documentation and Record Management
5.8 - Research Misconduct
5.9 - Making and Communicating Decisions
5.10 - Expert Opinion
5.11 - Minimising Duplication of Ethical Review
5.12 - Conflicts of Interest
5.13 - Monitoring of Approved Research
5.14 - Complaints Handling
5.15 - Timelines for Ethical Review
5.16 - Reporting and Accountability
5.17 - Fees and Charges
5.18 - Collaborative Research Groups
5.19 - Training Researchers
5.20 - Management of Research Data and Primary Materials
5.21 - Authorised Prescriber Endorsement
5.22 - Ionising Radiation
5.23 - Multisite Approval
5.24 - Insurance Indemnity Research Agreements and the VMIA
5.25 - Quality Assurance
5.26 - Safety Reporting
5.27 - Standard Operating Procedures

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 reults.

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

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

 

 


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

For additional information, please download the "Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018" at: https://www.nhmrc.gov.au/about-us/publications/safety-monitoring-and-reporting-clinical-trials-involving-therapeutic-goods

If you have any queries please contact the Research Governance Unit on 9231 2394 or e-mail research.ethics@svhm.org.au

Reporting of Serious Breaches by the SponsorSerious Breach Form (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 PartiesSuspected Breach Report Form (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
  • ONLY E-COPIES are required for breaches
  • For breaches concerning SVHM RGO please submit to: research.ethics@svhm.org.au

For additional information, please download the "Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018"

If you have any queries please contact the Research Governance Unit on 9231 2394 or e-mail research.ethics@svhm.org.au

Reporting of Non-Serious Breaches - Non-Serious Breach Form

The sponsor in collaboration with the site Principal Investigator should complete this form to report a non-serious breach - deviation.

A copy of this report should be provided to the Research Governance Officer (RGO) at the Principal Investigator’s site.

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

 

Hard Copies of Applications must be delivered to:

Office Location: Level 5, Aikenhead Building, Building E

41 Victoria Parade, Fitzroy, 3065

 

Mailing Address: St. Vincent’s Hospital Melbourne

Research Governance Unit (RGU), PO Box 2900

Fitzroy, 3065

Electronic Copies of Applications must be delivered to:

Research.Ethics@svhm.org.au

Subject: Project ID# and CPI Name


New Authorised Prescriber Applications

 

1. Authorised Prescriber Cover Sheet

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

 

Forms

Department of Health Standard Templates - St. Vincent's Hospital, Melbourne RGU uses the Department of Health VIC standard template for Ethics and Governance and Post Approval application

St. Vincent Hospital Specific Forms

Contracts and Agreements - St Vincent's Hospital, Melbourne RGU uses Australian Medicine Template and the Medical Technology Association of Australia Template for Clinical Trial Research Agreement and Indemnities 

  

Resources


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