Researchers must submit a Project Progress report for every Human Research Ethics Committee (HREC) approved project regardless of whether the research has started or how it has progressed.
HREC approval is ongoing but may lapse if the required project progress reports are not submitted to the reviewing HREC.
Single site lower risk/higher risk projects approved by Bayside Health (Peninsula) Human Research Ethics Committee (HREC) require a Project Progress Report (July-June) to be submitted annually by 30 August to Bayside Health (Peninsula).
The Site Audit Report must be submitted at the same time as the Project Progress Report.
Multi-site projects approved by an external certified reviewing HREC require a Project Progress Report to be submitted annually to the reviewing HREC by the due date and period set by that HREC. A copy of this report, its corresponding HREC acknowledgement and a Site Progress Report are then required to be submitted to Bayside Health (Peninsula).
The Site Audit Report must be submitted at the same time as the Site Progress Report.
How do I submit a Progress report?
- Progress reports are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register here Login – ERM Applications.
- The Principal Investigator (PI) must also have an ERM account for electronic signature through ERM. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
Lower Risk Research
- Create a Low Risk Notification Form (LRNF) as a sub-form of the Low Risk VIC on ERM.
- Select Progress Report as the purpose of the report.
- Complete and upload any publications or documents to illustrate project progress.
- PI signs the form using ERM’s electronic signature process.
- Submit the LNRF-Progress Report via ERM Applications only when all steps above are complete.
Higher Risk Research
- Create a Project Progress Report VIC as a sub-form of the HREA on ERM.
- Complete and upload any publications or documents to illustrate project progress.
- PI signs the report using ERM’s electronic signature process.
- Submit the Project Progress Report VIC via ERM Applications only when all steps above are complete.
Multi-site Research
- Create a Site Progress Report VIC as a sub-form of the SSA on ERM.
- Select Site Progress Report as the purpose of the report.
- Complete and upload a copy of the Project Progress Report submitted to the reviewing HREC and its corresponding HREC acknowledgement and any publications or other documents to illustrate project progress.
- If recruitment is paused on a dose escalation study your Summary of progess can note ‘Enrolment in the cohort(s) is closed. Further recruitment to the study is pending opening of planned future cohort(s).’
- PI signs the report using ERM’s electronic signature process.
- Submit the Site Progress Report VIC via ERM Applications only when all steps above are complete.
How do I submit a Site Audit report?
- Site Audit reports for all projects are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register here Login – ERM Applications.
- The Principal Investigator (PI) must also have an ERM account for electronic signature through ERM. The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
- Create a Site Audit Report as a sub-form of the SSA on ERM.
- If recruitment is paused on a dose escalation study check No to the question ‘Has recruitment been completed at your site?’.
- PI signs the report using ERM’s electronic signature process.
- Submit the Site Audit Report via ERM Applications only when all steps above are complete.
How are my reports reviewed?
The Project Progress Report will be reviewed at the monthly Bayside Health (Peninsula) HREC meetings and are due by the Agenda Closure Deadline prior to 30 August. An acknowledgement of the HREC review will be sent via ERM by the Bayside Health (Peninsula) Office for Research within 7 days of the meeting.
The Site Progress Report submission will be reviewed by the Bayside Health (Peninsula) Office for Research, followed by an acknowledgement of review via ERM.
The Site Audit Report submission will be reviewed by the Bayside Health (Peninsula) Office for Research, followed by an acknowledgement of review via ERM.
*Please note that fees are not applicable for progress and audit report submissions.