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Low Risk Research and Quality Assurance You are here:HomeResearchResearchersLow Risk Research and Quality Assurance Low Risk Case Study Reports Quality Assurance Low Risk Research SVHM HREC provides an expedited review pathway for all projects which are considered as “low risk”. There are no closing dates applicable for Low Risk Research. The expression "low risk research" describes research in which the only foreseeable risk is one of discomfort. Research, in which the risk for participants is more serious than discomfort, is not low risk. (NS Chapter 2.1) SVHM uses St Vincent's Hospital Application for Governance and Ethics (SAGE), as a one-stop portal for all High and Low Risk Ethics/Governance application submission and post-approval management of research projects. Quick reference guides and video tutorials on how to navigate SAGE is available here. To be eligible for Low Risk Review, the project MUST NOT INCLUDE: Women who are pregnant Children or young people under the age of 18 Persons with an intellectual disability or mental impairment of any kind Persons highly dependent on medical care Persons incompetent to provide informed consent People involved in illegal activities Prisoners or people on parole Research specifically recruiting Aboriginal and / or Torres Strait Islander people Persons not usually considered to be vulnerable but would be considered vulnerable in the context of this research project Additional clinical interventions and/or therapies Human genetic research or gene technology Derivation or use of human stem cells Discomfort or risk beyond that of routine care Deception of participants, concealment or covert observation Examining potentially sensitive or contentious issues Additional Radioactive substances / ionizing radiation Assisted reproductive technology (ART) Xenotransplantation Toxins / mutagens / teratogens / carcinogens Collection, use or disclosure of identifiable information The HREC reserves the right to promote projects to high risk at any time. Site-Specific Guidelines Please ensure the SVHM Site Specific Guidelines for submissions are followed when submitting your application SVHM Research Collaboration Agreement (RCA) with SVHM details inserted can be found under our Forms Tab. Please ensure standard DHHS templates and formatting are used for submissions Please ensure the Low and Negligible Risk Requirements are met Chief Principal Investigator / Principal Investigator Responsibilities in a Single Site and Multisite Project Roles and Responsibilities of CPI, PI, Investigator and Sponsor New Low Risk Ethics Applications Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents. To Submit a New Ethics Application: Please first complete the HREA form via Ethical Review Manager (ERM), then submit the application form by uploading it to the SAGE portal. *Please note: the RGU does not accept hard copy submission, only submissions via SAGE will be accepted. Please refer to SAGE Reference Guides here. Legal documents: please adhere to the SVHM Digital Signature Guidelines. 1. Cover Letter and Checklist - Ethics – Mandatory 1x e-copy 2. Fee Form – Mandatory Please include remittance advice when paying with EFT 1x e-copy 3. Human Research Ethics Application (HREA) Form – Mandatory *Please refer to the ERM User Guide for detailed instructions on how to create a HREA application on the ERM. If you still have troubles you can contact Infonetica on 02 9037 8404. *As of 01 January 2020, we will no longer accept LNR Forms. Low Risk Applications MUST complete a HREA. 1x e-copy 4. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved 1x e-copy 5. Master Participant Information and Consent Form (PICF) – if participants are enrolled in the study Different templates are available on the Department of Health website. IMPORTANT: SVHM will only consider PICF templates from the Department of Health. Please use the template(s) that are appropriate for the type of research you are conducting. Non-Interventional Interventional Participant Partner Pregnancy The following PICFs will need to be submitted for HREC Review: Multi-Site – Master PICF Single-Site with only SVHM Participating – SVHM site-specific PICF Participant Information and Consent Form Footer need to include the Version and Date. Please see below for recommendation: Master Template - [ProtocolNo.]National Mutual Acceptance PICF[type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy Complaints Contact Person Position Patient Liaison Officer at St Vincent’s Hospital Melbourne Telephone (03) 9231 1954 Email PLO@svhm.org.au Reviewing HREC Approving this Research and HREC Executive Officer Details Reviewing HREC Name St. Vincent’s Hospital Melbourne HREC Position HREC Executive Officer Telephone (03) 9231 6970 Email Research.ethics@svhm.org.au *Please note: these details must appear exactly as it is shown below 1x e-copy 6. Protocol or Research Plan – Mandatory *Australia's leading public funder for health and medical research (NHMRC) supports the use of the SPIRIT Statement and Checklist in the development of protocols. Please refer to the SPIRIT Statement for guidance on developing a protocol 1x e-copy 7. Budget – as per sponsor or institution guidelines 1x e-copy 8. Patient-Facing Materials – if participants are enrolled in the study Such as surveys, brochures, advertisements or questionnaires 1x e-copy 9. Form of Indemnity - HREC Review Only – for commercially sponsored studies where SVHM is providing premises for the conduct of HREC review SVHM Indemnified Party Details St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755 What is Required? - Insurance for Clinical Trials Information and Guide (2020) 1x e-copy (either scanned wet ink signature or docu-sign signature) 10. Letter of Support from Head of Department - for a single-site, low-risk application to SVHM 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 e-copy 11. Certificate of Insurance – for all commercially sponsored studies 1x e-copy 12. Research Team Good Clinical Practice (GCP) Certificates – Mandatory Provide a current and valid GCP certificates for the following study personnel: For Multi-site study – Coordinating Principal Investigator For Single-site study – Principal Investigator 1x e-copy 13. Research Team Curriculum Vitae (CVs) – Mandatory Provide a Curriculum Vitae for the following study personnel: For Multi-site study – Coordinating Principal Investigator and Principal Investigators of each site For Single-site study – Principal Investigator 1x e-copy New Low Risk Governance Applications Ethics Submission Guide - This guide can also be used for any questions regarding the necessity and role of the required documents. To Submit a New Governance Application: Please first complete the SSA form via Ethical Review Manager (ERM), then submit the application form by uploading it to the SAGE portal. *Please note: the RGU does not accept hard copy submission, only submissions via SAGE will be accepted. Please refer to SAGE Reference Guides here. Legal documents: please adhere to the SVHM Digital Signature Guidelines. 1. Cover Letter and Checklist - Governance – Mandatory 1x e-copy 2. Fee Form – Mandatory Please include remittance advice when paying with EFT 1x e-copy 3. HREC Approval Letter (including any amendment approval) – Mandatory 1x e-copy 4. Original Human Research Ethics Application (HREA) Form – Mandatory 1x e-copy 5.Site-Specific Assessment (SSA) Form – Mandatory *Please refer to the ERM User Guide for detailed instructions on how to create an SSA application on the ERM. If you still have troubles you can contact Infonetica on 02 9037 8404. 1x e-copy 6. Victorian Specific Module (VSM) – Mandatory if Victorian Sites are involved 1x e-copy 7. Master Participant Information and Consent Form (PICF) –if participants are enrolled in the study Submit all the original Master PICFs approved by the reviewing HREC. 1x e-copy 8. Site-Specific Participant Information and Consent Form (PICF) – if participants are enrolled in the study The following PICFs will need to be submitted for HREC Review: Create the SVHM Specific Participant Information and Consent Form based on the Reviewing HREC Approved Master PICF. Both tracked and clean SVHM Specific Participant Information and Consent Form Version are required for submission. SVHM Specific Participant Information and Consent Form Footer needs to include the Document name, Version and Date. Please see below for recommendation: Site Specific-[Protocol No.] SVHM Specific PICF [type eg. Main / Optional genetic] Verx.x Date dd/mm/yyyy Complaints Contact Person Position Patient Liaison Officer at St Vincent’s Hospital Melbourne Telephone (03) 9231 1954 Email PLO@svhm.org.au Local HREC Officer Contact Reviewing HREC Name St. Vincent’s Hospital Melbourne HREC Position HREC Executive Officer Telephone (03) 9231 6970 Email Research.ethics@svhm.org.au *Please note: these details must appear exactly as it is shown below 1x e-copy 9. Protocol or Research Plan – Mandatory Submit the original Protocol approved by the reviewing HREC. 1x e-copy 10. Budget – as per sponsor or institution guidelines 1x e-copy 11. Patient-Facing Materials – if participants are enrolled in the study Such as surveys, brochures, advertisements or questionnaires. All documents must have a footer that includes document name, version number and date. 1x e-copy 12. Form of Indemnity - Standard – for commercially sponsored studies where SVHM is providing premises for the conduct of the study SVHM Indemnified Party Details St Vincent's Hospital (Melbourne) Limited, 41 Victoria Parade, Fitzroy, Victoria 3065, ABN 22 052 110 755 What is Required? - Insurance for Clinical Trials Information 1x e-copy (either scanned wet ink signature or docu-sign signature) 13. Clinical Trial Research Agreement (CTRA) – for commercially sponsored, multi-site studies -or- 14. Research Collaboration Agreement (RCA) – for investigator initiated, multi-site studies SVHM Details for the RCA: Name of Institution: St Vincent's Hospital (Melbourne) Limited Address: 41 Victoria Parade, Fitzroy VIC 3065 ABN: 22 052 110 755 Research Collaboration Agreement (RCA) with SVHM details inserted can be found on our 'Forms' Page here. Please note that only the Director of Research and the Executive Officer can sign off on behalf of the institution, the principal investigator does not have the authority to sign off on behalf of the institution. Data Transfer Agreements & Material Transfer Agreements – for investigator initiated, multi-site clinical trials where there is a transfer of data or materials between SVHM and an external institution 1x e-copy (either scanned wet ink signature or docu-sign signature) 15. 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 e-copy 16. Certificate of Insurance – for commercially sponsored studies Submit the original Certificate of Insurance approved by the reviewing HREC. 1x e-copy 17. Research Team Good Clinical Practice (GCP) Certificates – Mandatory Provide a current and valid GCP Certificates for the following study personnel: SVHM Principal Investigator SVHM Associate Investigators / Research Coordinators 1x e-copy 18. Research Team Curriculum Vitae (CVs) – Mandatory Provide a Curriculum Vitae for the following study personnel: SVHM Principal Investigator SVHM Associate Investigators / Research Coordinators 1x e-copy Post Approval Amendments To Submit a Study Amendment: Please submit the application by uploading it to SAGE, see Quick Reference Guide here *Please note: the RGU does not accept hard copy submission. Only submissions via SAGE will be accepted. Legal documents: please adhere to the SVHM Digital Signature Guidelines. 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 docu-sign signature) 4. CV of the new CPI/PI 1x e-copy 5. GCP Certificate of the new CPI/PI 1x e-copy 6. Research Collaboration Agreement (RCA) - if applicable 1x e-copy (either scanned wet ink signature or docu-sign 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 docu-sign signature) 4. CV of the new CPI/PI 1x e-copy 5. GCP Certificate of the new CPI/PI 1x e-copy 6. Letter Specifying dates of the temporary change to PI 1x e-copy Changing Members of a Research Team (Associate Researcher or Research Coordinator) 1. Changing Members of a Research Team Form 1x e-copy (either scanned wet ink signature or docu-sign signature) 2. CV of the new Research Team Member 1x e-copy 3. GCP Certificate of the new Research Team Member 1x e-copy Updated Protocol 1. Amendment Request Form *Explaining the nature of the amendment and whether the changes/updates warrants an updated PICF 1x e-copy 2. Fee Form - please include remittance advice when paying with EFT 1x e-copy 3. Updated Protocol/ Investigator Brochure – including updated version numbers and dates 1x e-copy 4. Tracked Changes of the Protocol/Investigator Brochure 1x e-copy 5. Summary of Changes 1x e-copy Updated Participant Information and Consent Form (PICF) 1. Amendment Request Form *Explaining the nature of the PICF changes 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 Patient-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 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 (either scanned wet ink signature or docu-sign signature) 4. Master PICF – if changing from a single to multi-site study a master PICF will be required 1x e-copy 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 - 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 docu-sign signature) Addition of Satellite Site Please view this document for addition information as to whether your request qualifies under this category of site addition. 1. Amendment Request Form 1x e-copy 2. Fee Form - please include remittance advice when paying with EFT 1x e-copy 3. SVHM Addition of Satellite/Recruitment/Service Site Form 1x e-copy 4. 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 docu-sign signature) 7. Insurance Certificate - for commercially sponsored studies 1x e-copy 8. CTRA - for commercially sponsored trials adding a rural site not under the same legal entity as primary site -or- 8. Research Collaboration Agreement (RCA) – if investigator initiated, unsponsored trials adding a rural site not under the same legal entity as primary site 1x e-copy (either scanned wet ink signature or docu-sign signature) Addition of Recruitment Site Please view this document for addition information as to whether your request qualifies under this category of site addition. 1. Amendment Request Form 1x e-copy 2. Fee Form - please include remittance advice when paying with EFT 1x e-copy 3. SVHM Addition of Satellite/Recruitment/Service Site Form 1x e-copy 4. 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 docu-sign signature) Addition of Service Site Please view this document for addition information as to whether your request qualifies under this category of site addition. 1. Amendment Request Form 1x e-copy 2. Fee Form - please include remittance advice when paying with EFT 1x e-copy 3. SVHM Addition of Satellite/Recruitment/Service Site Form 1x e-copy 4. Letter of Support from Site 1x e-copy 4. Service Agreement 1x e-copy (either scanned wet ink signature or docu-sign signature) All Other Changes (Administrative) 1. Amendment Request Form 1x e-copy 2. Fee Form - please include remittance advice when paying with EFT 1x e-copy 3. Documents requiring review 1x e-copy Annual Progress/Final Report Requirements Annual Progress/Final Reports - Due 1 May each year Important update (2025) Effective 2025, all annual progress report cannot be submitted before 1 May to ensure continuous reporting with no gaps between reports, maintaining data completeness and accuracy. Change to annual progress report submission period 2025 What are the annual reporting requirements and how to submit them Annual Report FAQs 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. Acknowledgement of a submitted annual progress report will generally be provided within 2 months of submission - this timeline may be extended due to the significant volume of reports received. For further information, please contact Research Integrity and Compliance Assistance on 03 9231 6972 or email: svhm.ResearchAnnualR@svha.org.au All Annual Reports and Final Reports are to be submitted under the relevant projects on SAGE. Different report forms are required depending on the project types (Summary below). For more information regarding how to submit an annual report on SAGE, please refer to these Annual Report Submission Guides. Project Type Report Form Required Where to Submit Whose responsibility to submit Ethics only project - no SVHM site is involved Progress/Final Report (HREC) Milestone tab under the SVH Project Investigator-initiated study: CPI Commercially-sponsored study: Sponsor Governance only project - study reviewed by an external HREC Site Report/Closure Form (RGO) - one report for each site Milestone tab under the SSA Project for each site PI only Both Ethics and Governance project - Single-site study where SVHM is both the HREC and the only participating site Site Report/Closure Form (RGO) Milestone tab under the SSA Project PI only Both Ethics and Governance project - Multi-site study where SVHM is the HREC and one of the participating sites Both HREC and RGO report forms are required Milestone tab under the SVH Project for HREC Form; and the SSA Project for each RGO Form/s HREC Report: Investigator-initiated study: CPI Commercially-sponsored study: Sponsor RGO Report: PI only Ethics project with a closure of an external site - Closure of a non-SVHM RGO site approved under SVHM HREC External Site Closure Form (HREC) Form tab under the SVH Project How to submit an external site closure form Investigator-initiated study: CPI Commercially-sponsored study: Sponsor New Case Study Report Applications Case Study Reports A case study report is an article that describes a particular patient’s diagnosis and treatment plan. Often, a case study is used for the description of an unusual diagnosis or complications in treatment. Process of Review The Research Governance Unit (RGU) will be reviewing applications for case study reports. Once reviewed, a formal letter of approval will be issued. The RGU will endeavour to have a response to your application in approximately 7-10 business days. Please submit all Case Study Report applications to research.ethics@svhm.org.au There are no closing dates for Case Study reports ONLY ELECTRONIC COPIES are required. Please DO NOT submit hard copies to our office. Please ensure the following documents are completed upon submitting to research.ethics@svhm.org.au Document Instructions 1. Case Study Report Please submit your case study abstract using our template as a guide 2. CV of Researcher(s) Please submit CVs of all researchers involved in the Case Study Report 3. Consent Form Please use the template provided here 4. Support from Head of Department Please provide either a letter of support from Head of Department, or Chief Medical Officer if the Head of Department are directly involved in the case report. *Please note: if the Head of Department/Chief Medical Officer signs the Case Study Report document, a separate letter is not required. Quality Assurance and Internal Audits Quality Assurance and Internal Audits The Quality Assurance and Internal Audit processes are essential for ensuring compliance and quality in all research activities. Regular audits are conducted to ensure adherence to research protocols and guidelines. Feedback and recommendations are provided to researchers to improve research practices. Please submit all required documentation to the Quality Assurance Office. Document Instructions 1. Audit Report Submit the completed audit report. 2. Corrective Actions Include details of corrective actions taken in response to audit findings. New Quality Assurance & Internal Audit Applications Please submit all QA applications to qisubmissions@svha.org.au There are no closing dates for QA activities. The use of ERM is not required for QA activities. ONLY ELECTRONIC SUBMISSIONS will be accepted for QA activities. Please ensure the following documents are completed upon submitting to QA (qisubmissions@svha.org.au): All necessary documents can be found in downloadable form by clicking here. 1. QA Cover Sheet 2. Quality Assurance/Audit Application Form Electronic signature is accepted for this form 3. QA Participant Information/Consent Form (PICF) – if applicable 4. Participant Facing Documents - if applicable Such as surveys, questionnaires, etc. 5. Fee Form – if applicable Required for all QA activities that are intended to be published Quality Assurance Post-Approval Amendments Amendments are required for any change to the approved project, including changes to the research plan, data collection, or change of investigators. Please ensure the following documents are completed upon submitting amendments to QA (qisubmissions@svha.org.au): All necessary documents can be found in downloadable form by clicking here. 1. QA Cover Sheet Please complete for any changes to the activity including: Request for extension of the project Addition of sites 2. Updated Documents – if applicable PICF (tracked and clean) with updated version numbers and dates Protocol (tracked and clean) with updated version numbers and dates Surveys, questionnaires, etc. Change of Associate Investigator Form (CMORT) Change of Principal Investigator Letter If Publishing - Please email us with QA number, QA cover sheet and a Fee Form (for publishing approval) Quality Assurance Annual Reporting Requirements A final report for QA projects will be due by the completion date proposed by the investigator on the QA application form. The completion and submission of a final report is part of the conditions of approval for all projects. If the project has not been completed by the chosen date, please inform the Research Governance Unit. Please submit QA final/progress reports to qisubmissions@svha.org.au using the following templates: QA Cover Sheet (if your study is continuing past the proposed completion date) Project Final Report (when your study has been completed) - this should be the finalised document created as part of your QA activity. This can be in whatever form your QA results are in (eg. PowerPoint Presentation, Poster, Flyer, Journal Article, etc.) Please include “Final/Progress Report” and your QA study number in the email subject. Contact Us For more information visit the Research Governance Unit Contact Page