Calvary Health Care Adelaide HREC

The aim of ethical review is to ensure that high ethical standards are maintained in research projects conducted at Calvary Health Care Adelaide (CHCA), to protect the interests of research subjects, investigators and the institution. In carrying out these functions, the HREC, at all times, takes into consideration guidelines issued by the NHMRC together with the Catholic Health Australia Code of Ethical Standards for Catholic Health and Aged Care Services in Australia (2001) and local cultural and social attitudes.

As of 08 Dec 2020, the ethical review of new and existing proposals will be provided by the Human Research Ethics Committee (HREC) of St Vincent’s Hospital, Melbourne (SVHM). 

 

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

 

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

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

The HREC reviews studies such as:

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

SVHM HREC provides ethical review for studies to be conducted at the following Calvary Health Care sites:

  • Calvary Adelaide Hospital
  • Calvary Central Districts Hospital
  • Calvary North Adelaide Hospital

Committee Information

HREC Meeting Dates

Calvary Site-Specific Information

 

Chief Principal Investigator / Principal Investigator Responsibilities in Trials

Important Notices

2021 Changes

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

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

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

 Good Clinical Practice (GCP) Certificates  

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

  • Calvary Health Care Adelaide (and affiliated facilities) as a study site – GCP Certificate of the Coordinating Principal investigator, Principal Investigator and all Associate Investigators

New Ethics Applications

Process of Review

Initial Review (New High/Low Risk Ethics Applications)

Prior to submission to the SVHM HREC researchers must obtain endorsement of the research proposal to be undertaken at a Calvary Hospital in Adelaide. 

Please complete and submit the following form:

  • CHCA Research Governance Submission Form – Part A 
Email completed form to: SA-CHCA-HREC@calvarycare.org.au

After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at Calvary Health Care facilities. Research must not commence until governance authorisation has been granted.  For Single Site Ethics applications, Governance may be granted at the same time as Ethics.

To Submit a New Ethics Application

  • Please make sure to complete a submission via HREA.gov.au
  • Once this has been completed and submitted, please email through a PDF/Word copy of all documents to research.ethics@svhm.org.au

Please include the following information in the email and subject:

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

*Please note: we will not be asking for hard copies to be submitted at this time.

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 this is executed correctly

Please see our Digital Signature Guidelines

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

1. Cover Letter and Checklist - Ethics

1x e-copy

2CHCA Endorsement - Research Governance Submission Form – Part A

1x e-copy 

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

1x e-copy

4. Human Research Ethics Application (HREA) Form

1x e-copy

5. Medical Physicist Letter – if ionising radiation is involved

  • Radiation - Notification to the Reviewing HREC – for all studies involving ionising radiation
  • Medical Physicist Report – for studies involving ionising radiation that is additional to standard care. The report MUST be conducted by a medical physicist. One report must be submitted for each site seeking ethical approval.

1x e-copy

6. Participant Information and Consent Form (PICF) - Master Version

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

Please adhere to the Calvary Site-Specific Guidelines

1 x e-copy

7. Protocol or Research Plan

1x e-copy

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

 

1x e-copy

9. Budget – as per sponsor or institution guidelines

 

1x e-copy

10. Patient-Facing Materials

Such as surveys, brochures, advertisements or questionnaires

 

1x e-copy

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

SVHM Indemnified Party Details

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

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

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

 

1x e-copy

13. Certificate of Insurance – as applicable

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

 

1x e-copy

14. Investigator Clinical Practice (GCP) Certificates

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

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

1x e-copy

15. Investigator Curriculum Vitae (CVs)

 

1x e-copy

New Governance Applications

Process of Review

Post Ethics Approval (New High/Low Risk Governance Applications)

Prior to submission to the SVHM RGO researchers must obtain endorsement of the research proposal to be undertaken at a Calvary Hospital in Adelaide.

Please complete and submit the following form:
  • CHCA Research Governance Submission Form – Part B
Email completed form to: SA-CHCA-HREC@calvarycare.org.au

After Ethics approval has been obtained from an accredited HREC for your project, Governance authorisation must be obtained before conducting your research at Calvary Health Care facilities. 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 Calvary Site Specific Guidelines
  • We will endeavour to have a response within 7-10 working days once all necessary paperwork has been submitted 

To Submit a New Governance Application:

  • Please make sure to complete a submission via the HREA.gov.au
  • Once this has been completed and submitted, please email through a PDF of all documents to research.ethics@svhm.org.au

Please include the following information in the email and subject:

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

*Please note: we will not be asking for hard copies to be submitted at this time.

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 this is executed correctly

Please see our Digital Signature Guidelines

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

1. Cover Letter and Checklist - Governance

1x e-copy

2. CHCA Endorsement - Research Governance Submission Form – Part B

1x e-copy 

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

 

1x e-copy

3. HREC Approval Letter

 

1x e-copy

4. Original Human Research Ethics Application (HREA) Form

1x e-copy

5. Site Specific Assessment (SSA) Form 

 

1x e-copy

6. 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 Calvary.
 

1x e-copy

7. HREC Approved Master Participant Information and Consent Form (PICF)

1x e-copy

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

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

Please adhere to the Calvary Site-Specific Guidelines

1x e-copy

9. Protocol or Research Plan

 

1x e-copy

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

 

1x e-copy

11. Budget – as per sponsor or institution guidelines

 

1x e-copy

12. Patient-Facing Materials

Such as surveys, brochures, advertisements or questionnaires

 

1x e-copy

13. Form of Indemnity - Standard – for commercially sponsored trials where Calvary is providing premises for the conduct of the study

   

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

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

-or-

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

                             

Please note that only the Director of Mission 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 signature)

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

 

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


 

1x e-copy

17. Certificate of Insurance – as applicable

What is Required? - Insurance for Clinical Trials Information and Guide (2021)

 

1x e-copy

18. Investigator Good Clinical Practice (GCP) Certificates

GCP Certificates will need to be submitted when making an Ethics or Governance Application to Calvary Health Care facilities for the following study personnel:

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

1x e-copy

 19. Investigator Curriculum Vitae (CVs) 1x e-copy 

Post Approval Amendment – HREC Review (Calvary 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 Calvary Site Specific Guidelines
  • We will endeavour to have a response within 7-10 working days once all necessary paperwork has been submitted

 

To Submit a Study Amendment:

  • Please make sure to submit a PDF copy of all documents related to the amendment to research.ethics@svhm.org.au

Please include the following information in the email and subject:

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

*Please note: we will not be asking for hard copies to be submitted at this time.

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 - please make sure this is executed correctly

 

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


Change of Principal Investigator (Permanent)

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. Change/Addition of Coordinating or Principal Investigator Form

 

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

4. CV of the new CPI/PI

 

1x e-copy

5. GCP Certificate of the new CPI/PI

 

1x e-copy

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

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

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

 

1x e-copy

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

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

 


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

1. Amendment Request Form

 

1x e-copy

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

1x e-copy

3. Change/Addition of Coordinating or Principal Investigator Form

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

4. CV of the new CPI/PI

1x e-copy

5. GCP Certificate of the new CPI/PI

1x e-copy

6. Letter specifying dates of the temporary change to PI

 

1x e-copy


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

1. Changing Members of a Research Team Form

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

2. CV of the new Research Team Member

1x e-copy

3. GCP Certificate of the new Research Team Member

1x e-copy


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

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. Updated Protocol/ Investigator Brochureincluding updated version numbers and dates

 

1x e-copy

4. Tracked Changes of the Protocol/Investigator Brochure

 

1x e-copy

5. Summary of Changes

 

1x e-copy


Updated Participant Information and Consent Form (PICF) 

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

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

 

1x e-copy

4. Tracked Changes of the PICF

 

1x e-copy


Updated Participant Facing Documents

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

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

 

1x e-copy

4. Tracked Changes to the patient-facing documents

1x e-copy


Addition of Sites

1. Amendment Request Form

 

1x e-copy

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

1x e-copy

3. Change/Addition of Coordinating or Principal Investigator Form

 

1x e-copy

4. Site Medical Physicist Reportif ionising radiation is involved

1x e-copy

5. CV of the site Principal Investigator (PI)

 

1x e-copy

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

1x e-copy

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

-or-

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

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

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

1x e-copy

 


Addition of Satellite Site

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

1. Amendment Request Form

1x e-copy

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

 

1x e-copy

3. Calvary Addition of Satellite/Recruitment/Service Site Form  

1x e-copy

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

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

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

7. Insurance Certificate - for commercially sponsored studies  1x e-copy

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

-or-

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

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

Addition of Recruitment Site

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

1. Amendment Request Form

1x e-copy

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

 

1x e-copy

3. Calvary Addition of Satellite/Recruitment/Service Site Form  

1x e-copy

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

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

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


Addition of Service Site

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

1. Amendment Request Form

1x e-copy

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

 

1x e-copy

3. Calvary Addition of Satellite/Recruitment/Service Site Form  

1x e-copy

4. Letter of Support from Site 1x e-copy

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

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

 


Addition of Service Site

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

1. Amendment Request Form

1x e-copy

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

 

1x e-copy

3. Calvary Addition of Satellite/Recruitment/Service Site Form  

1x e-copy

4. Letter of Support from Site 1x e-copy

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

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


All Other Changes (Administrative)

1. Amendment Request Form

1x e-copy

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

 

1x e-copy

3. Documents requiring review

 

1x e-copy

 

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

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 Calvary Site Specific Guidelines
  • We will endeavour to have a response within 7-10 working days once all necessary paperwork has been submitted

 

To Submit a Study Amendment:

  • Please make sure to submit a PDF copy of all documents related to the amendment to research.ethics@svhm.org.au

Please include the following information in the email and subject:

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

*Please note: we will not be asking for hard copies to be submitted at this time.

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 - please make sure this is executed correctly

 

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


Change of Calvary Principal Investigator (Permanent)

1. Amendment Request Form

1x e-copy

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

 

1x e-copy

3. HREC Amendment Approval  

1x e-copy

4. Change/Addition of Coordinating or Principal Investigator Form

 

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

5. CV of the new CPI/PI

1x e-copy

6. GCP Certificate of the new CPI/PI

1x e-copy

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

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

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

 

1x e-copy

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

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

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

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. HREC Amendment Approval  

1x e-copy

4. Change/Addition of Coordinating or Principal Investigator Form

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

5. CV of the new CPI/PI

1x e-copy

6. GCP Certificate of the new CPI/PI

 

1x e-copy

7. Letter specifying dates of the temporary change to PI

 

1x e-copy


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

1Changing Members of a Research Team Form

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

2. CV of the new Research Team Member

1x e-copy

3. GCP Certificate of the new Research Team Member

1x e-copy


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

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. HREC Amendment Approval
 

1x e-copy

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

 
 

1x e-copy

5. Tracked Changes of the Protocol/Investigator Brochure

 

1x e-copy

6. Summary of Changes

 

1x e-copy


Updated Participant Information and Consent Form (PICF) 

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. HREC Amendment Approval  

1x e-copy

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

 

1x e-copy

5. Tracked Changes of the PICF

1x e-copy


Updated Participant Facing Documents

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. HREC Amendment Approval
 

1x e-copy

4. Updated patient-facing documents

 

1x e-copy

5. Tracked Changes to the patient-facing documents

 

1x e-copy


All Other Changes (Administrative)

1. Amendment Request Form

 

1x e-copy

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

 

1x e-copy

3. HREC Amendment Approval  

1x e-copy

4. Documents requiring review

 

1x e-copy

Annual Reporting Requirements

Annual Safety Reports

Due on the anniversary of study approval
  • For clinical trials involving an investigational medicinal product or investigational medical device
  • The completion and submission of an annual safety report is part of the conditions of ethical approval for all projects.
  • For further information, please contact Julie Luong on 03 9231 6970 or email SAE.ClinicalTrial@svha.org.au

Annual Reports Should Generally Include

  • A brief description and analysis of new and relevant findings
  • IMPs not on the TGA Register - a brief analysis of the safety profile of the IMP and its implications for participants taking into account all safety data
  • A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
  • A description of any measures taken or proposed to minimise risks

Submitting Annual Safety Reports

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

Annual Project/Progress Reports

Due on 01 May - Annual Reports for projects that have been approved in January to April in any year do not need to be submitted until 01 May the following year

Failure to submit progress reports within 45 days following the 01 May submission deadline may lead to a suspension of the ethical approval for the study

  • The completion and submission of an annual report is part of the conditions of ethical approval for all projects.
  • For further information, please contact Research Integrity and Compliance Assistance on 03 9231 2394 or email: svhm.ResearchAnnualR@svha.org.au

Submitting Annual Reports

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

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

Progress Report – Project Form

*Completed by the Sponsor

HREC

Due 01 May

Project Final Report/Site Closure Report

*Completed by the Sponsor

HREC/

RGO

Due

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

-or-

  • Upon site closure (multi-site project)

Progress Report – Site Form

*Completed by the Principal Investigator

RGO

Due 01 May

Safety Reporting (SAEs, SSIs, USMs)

*Annual Safety Report Information in Header above, under "Annual Reporting Requirements"

For more details on safety reporting please view the "NHMRC Guide on Safety monitoring and reporting in clinical trials involving therapeutic goods" on our Resources page.

This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes. The Guidance is also broadly applicable to all clinical trials involving therapeutic goods.


Submitting Safety Reports

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

Definitions

Adverse Reaction

Any untoward and unintended response to an investigational medicinal product related to any dose administered.

Serious Adverse Event (SAE)

Any adverse event/adverse reaction that results in:

  • Death,
  • Life-threatening, requires hospitalisation or prolongation of existing hospitalisation,
  • Results in persistent or significant disability or incapacity,
  • Congenital anomaly or birth defect.

Suspected Unexpected Serious Adverse Event (SUSAR)

An adverse reaction that is both serious and unexpected. It is also not consistent with the investigator brochure or product information.

Significant Safety Issue (SSI)

A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.A SSI can be a SAE that is associated with the study (Definitely related, Probably related and Possibly related).

  • A serious adverse event that could be associated with the trial procedures and that requires modification of the conduct of the trial
  • A hazard to the patient population, such as lack of efficacy of an IMP used for the treatment of a life-threatening disease.
  • A major safety finding from a newly completed animal study (such as carcinogenicity)
  • A temporary halt/termination of a trial for safety reasons
    Recommendations of the Data Safety Monitoring Board, where relevant for the safety of participants, such as an increase in frequency or severity of an expected adverse reaction
  • Single case events (e.g. toxic epidermal necrolysis, agranulocytosis, hepatic failure) that lead to an urgent safety measure.

Urgent Safety Measure (USM)

A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety. Note: This type of significant safety issue can be instigated by either the investigator or sponsor and can be implemented before seeking approval from HRECs or institutions.


Serious Adverse Events (SAEs)

  • In the event of a Serious Adverse Event (SAE) Investigators are required to report to Sponsor within 24 hours of becoming aware of the SAE.
  • The sponsor, on becoming aware of the reported SAE made by Investigators, will be required to notify HREC and TGA based on the type of SAE and the associated timeline as described below:

USM

Within 72 hours of measures being taken

The HREC is not required to approve USMs but may consider whether any proposed actions are appropriate

SSI – involving notification of an amendment

Within 15 calendar days of sponsor being aware of the issue

Sponsors should submit to the HREC an amendment relating to any revised trial documentation, without undue delay

Temporary halt of a trial for safety reasons

Within 15 calendar days of the sponsor decision to halt the trial

Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

Early termination of a trial for safety reasons

Within 15 calendar days of the sponsor decision to halt the trial

Where it is necessary to seek ethical review of related actions (e.g. informing participants or arranging continuing care and follow-up), a letter describing these actions should be submitted to the HREC within 15 calendar days of the temporary halt

SUSAR – Suspected unexpected Serious Adverse Reactions

Life-threatening AUS – within 7 calendar days

All other – within 15 calendar days

Must be reported to the Therapeutic Goods Australia (TGA)

Events that involve Calvary 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 Calvary participants need to be reported to SVHM HREC

*If Calvary Health Care Adelaide is nominated as the trial sponsor, Calvary Health Care Adelaide 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 Calvary Health Care Adelaide.

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 Calvary Health Care Adelaide.

7. What if Sponsor is required by their global policies mandating the reporting of individual case of SUSARSs and six monthly line listing to HREC?

St Vincent’s Hospital, Melbourne HREC will accept and acknowledge the individual case of SUSARS and six monthly line listing if it mandated in the Sponsor global policies.

Serious and Non-Serious Breaches

NHMRC 2018 Update

The NHMRC has introduced a new document called “Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018”. 

The European Union (EU) Clinical Trials Regulation (536) introduced the term ‘serious breach’ to describe the sub-set of deviations that should be reported to review bodies and the Integrated Addendum to ICH E6 R1: Guidelines for Good Clinical Practice (ICH E6 R2) requires the sponsor to perform a root cause analysis for ‘noncompliance [deviations] that significantly affect or has the potential to significantly affect human subject protection or reliability of trial 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 within 7 days.

Non-Serious Breach

A minor, deviation from Good Clinical Practice or to the protocol that is unlikely to affect:

  • The safety or rights of a trial participant
  • The reliability and robustness of the data generated in the clinical trial

Non-Serious Breaches must only be reported to the RGO site at which the breach occurred within 14 days.

 

 

Please see our document "Breach Report Guidelines" for more information as to what needs to be reported to the RGO/HREC here.

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


Reporting Serious Breaches

  • Please submit serious breach reports to the reviewing HREC and the RGO site at which the breach occurred
  • ONLY E-COPIES are required for breaches
  • For breaches concerning Calvary HREC/RGO please submit to: research.ethics@svhm.org.au
 

Reporting of Serious Breaches by the Sponsor

Breach Report - Serious (Sponsor)

Sponsors have the primary responsibility of determining whether any suspected breach meets the definition of a serious breach.

Sponsor is required to:

  • Report serious breaches to the Reviewing HREC within 7 calendar days of confirming a serious breach has occurred and provide follow-up reports when required.
  • Notify the TGA and the reviewing HREC if the serious breach leads to the closure of the site.
  • Report to the TGA any serious breach that involves a defective product that may have wider implications for the supply chain for that marketed product:
  • Commercial sponsors report to the TGA using existing product surveillance processes
  • Non-commercial sponsors (e.g. universities) may either report to the TGA directly or to the Marketing Authorisation Holder/manufacturer (who would report to the TGA).

Reporting of Serious Breaches by Third Parties

Breach Report - Suspected (Third Party)

A third party refers to any entity (other than the trial sponsor) wishing to report a suspected breach.

A third party (e.g. trial sites) may identify a serious breach and report it directly it to the reviewing HREC.

This would usually be appropriate if:

  • The investigator/institution has good evidence that a serious breach has occurred but the sponsor disagrees with their assessment and is unwilling to notify the HREC
  • The investigator/institution has become aware that the sponsor may have committed a serious breach
 

Reporting Non-Serious Breaches

  • Please submit non-serious breach reports ONLY to the RGO site at which the breach occurred
  • For breaches concerning Calvary please submit to: research.ethics@svhm.org.au

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 -

Breach Report - Non-Serious

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

It is the responsibility of the Principal Investigator to report the non-serious breach to the RGO at which the breach occurred.

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

Authorised Prescriber Scheme

What is an authorised prescriber scheme?

There are circumstances where patients may require access to medicines, biologicals or medical devices that have not been approved for supply by the TGA.

The Authorised Prescriber scheme allows authorised medical practitioners to supply specific unapproved therapeutic goods to a specific class of patients, without seeking approval or notification on an individual patient, as is the case with the Special Access Scheme.

What are the requirements to be an authorised prescriber?

To be an Authorised Prescriber the medical practitioner must have:

  • The training and expertise appropriate for the condition being treated and the proposed use of the product
  • The Authorised Prescriber must be able to best determine the needs of the patient
  • To monitor the outcome of therapy.

How do medical practitioners become an authorised prescriber?

The following are the steps to becoming an Authorised Prescriber:

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

 


Process of Review

After HREC Approval has been granted, you will need to submit an application to the TGA for evaluation. This submission should include:

  • A completed Authorised Prescriber Scheme application form  (Obtained from the TGA Website). Ensure the indication listed on this form is the indication. 
  • HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed
  • Please visit the TGA Website for more guidance regarding the application process

Please email Authorised Prescriber Applications to:


 

 

 


After HREC Approval had been granted 

You will need to submit an application to the TGA for evaluation. This submission should include:

  • a completed Authorised Prescriber Scheme application form (Obtained from the TGA Website) . Ensure the indication listed on this form is the indication.
  • HREC letter of approval or a letter of endorsement from a specialist college, including a declaration that all necessary documentation has been reviewed

Reporting Requirements of an Authorised Prescriber

Six-Monthly Periodic Reporting to TGA and HREC

  • Number of patients treated during the six-month period
  • Needs to be sent within one month after the reporting period
  • Report must be sent even if no patients have been treated

Reporting Adverse Events and Product Defects to HREC

  • Report any adverse event or product defect related to the unapproved good
  • Must be reported within 15 calendar days of learning of it

Codes

SVHM Radiation Safety Licence Number: 300042061

SVHM TGA Sponsor Reference Number: 28204

SVHM CTN Code: 30514

SVHM HREC Code: EC00343


Contact Us

For more information visit the Research Governance Unit Contact page