SAGE Resource Pack You are here:HomeResearchResearchersResource for Researchers SAGE - A new online portal for St Vincent's Application for Governance and Ethics St Vincent’s Hospital Melbourne HREC and RGO use the St Vincent’s Application for Governance and Ethics (SAGE) platform to manage all submissions. SAGE streamlines the ethical and governance review process for new and existing studies, providing a central portal for new applications, amendments, and project updates. Please visit https://research.svhm.org.au/ to log in to SAGE. All HREC and RGO submissions must be completed via SAGE. Expand the relevant sections below to access the appropriate user guides. Overview Login Instructions Basic Navigation Manual for Application and Projects Guides for Form Access (only apply to post-approval submission access) Below, you’ll find the types of submission forms and their locations within SAGE. For step-by-step instructions, please expand the relevant sections below to access the correct user guides. Type of Submission Where to locate the form Form Type to Select on SAGE New Ethics or Governance Application SAGE Homepage New Project Registration Form Governance Application after SVHM HREC Approval SSA Application > Edit Application Site-Specific Application Form Amendments Requests including Administrative Changes, Change of CPI/PI, Addition of New Site + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project For Ethics: Amendment Request Form For Governance: Site Amendment Form Acknowledgements including DSMB/SRC/DMC/DRC/IDSMC Meeting Reports + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Acknowledgement for HREC: Acknowledgement Request Site-Specific: Acknowledgement Request (Site) Safety Adverse Events + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Safety Event Report Form Non-Serious & Serious Breach Reports + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Breach Report Form DSUR & Annual Safety Reports + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Annual Safety Report Form Annual Project Progress Report (HREC) and Final Project Report Milestone Tab under the SVH Project Progress/Final Report (HREC) Annual Site Progress Report (RGO Form) and Site Closure Report Milestone Tab under the SSA Project Site Progress/Closure Report (RGO) External Site Closure Report + New Form under the SVH Project only For SVHM Site Closure, please refer to the row above External Site Closure Form Pre-Approval Submissions (HREA and SSA application stage) SAGE Submission Guidelines for Different Application Types (Pre-Approval Stage) Ethics-Only Submission: For studies where SVHM is not a participating site. Governance-Only Submission: For studies where SVHM is a participating site, and the study has been approved by an NMA HREC. Ethics and Governance Submission (High-Risk or Multisite Study): For high-risk studies or those involving multiple sites. Ethics and Governance Concurrent Submission (Low-Risk Single-Site Study): For low-risk studies where SVHM is the only participating site. SAGE Status Dictionary: Ethics Application How to Respond to an Ineligible Application How to Respond to a Letter of Query Exporting applications from SAGE to ERM Post-Approval Submissions (Active research studies) Users may need to be given special permission to access these forms - For more information, please refer to this Guide on Form Access. Amendment Request Guides Amendment or Acknowledgement Request Guide for both Ethics and Site Projects Amendment - Responding to a More Information Required Email How to Withdraw an Amendment or Acknowledgement Form Annual Report Submission SVHM Annual Report Submission Guide (updated 2025) Annual Report FAQ Sheet Outcomes of Annual Report and How to Resubmit/Respond to Query How to Download Previously Submitted Report Please complete the RGO Progress Report under the milestone tab for any of these sites: St Vincent's Hospital Melbourne (Public), St V's Private Hospital or Mercy Health) External Site Closure Form (Non-SVHM Site) How to submit an External Site Closure Form (For any site that is not St Vincent's Hospital Melbourne (Public), St V's Private Hospital or Calvary Health) Breach Notification How to submit a Breach Report Form Safety Event Reporting How to submit a Safety Event Report Annual Safety Report (ASR) How to submit an Annual Safety Report (ASR) Status Dictionary Form Locations All submissions are now completed and managed via SAGE, please see below for the types of submission forms and where to locate them on SAGE. Type of Submission Where to locate the form Form Type to Select on SAGE New Ethics or Governance Application SAGE Homepage New Project Registration Form Governance Application after SVHM HREC Approval SSA Application > Edit Application Site-Specific Application Form Amendments Requests including Administrative Changes, Change of CPI/PI, Addition of New Site + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project For Ethics: Amendment Request Form For Governance: Site Amendment Form Acknowledgements including DSMB/SRC/DMC/DRC/IDSMC Meeting Reports + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Acknowledgement for HREC: Acknowledgement Request Site-Specific: Acknowledgement Request (Site) Safety Adverse Events + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Safety Event Report Form Non-Serious & Serious Breach Reports + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Breach Report Form DSUR & Annual Safety Reports + New Form under the relevant projects For Ethics: SVH Project For Governance: SSA Project Annual Safety Report Form Annual Project Progress Report (HREC) and Final Project Report Milestone Tab under the SVH Project Progress/Final Report (HREC) Annual Site Progress Report (RGO Form) and Site Closure Report Milestone Tab under the SSA Project Site Progress/Closure Report (RGO) External Site Closure Report + New Form under the SVH Project only For SVHM Site Closure, please refer to the row above External Site Closure Form