REGI

Human Research Ethics Committee (HREC)

The following dates and submission deadlines apply to the Barwon Health Human Research Ethics Committee meetings held throughout 2023 and 2024.

NB. There is no deadline for negligible risk/QA applications, site-specific assessment applications or amendments.

*Note earlier submission and meeting dates due to public holidays

The HREC’s feedback from the meeting will be sent on the Friday following each meeting.

Research Management Committee (RMC)

Research Management Committee meetings are held every Wednesday at 3pm.

Principal Investigators (PIs) may be invited to attend the meeting to discuss their project and answer any queries that arise. The RMC encourages PIs to discuss complex projects with RMC early in development. If you would like to attend an RMC meeting for an early discussion of your project, please contact Nicola Cooley on [email protected].

Expected timeframes for commercially sponsored trials:

• Receive Research Governance Officer (RGO) review within 7 working days of submission
• Once RGO deems submission complete and satisfactory, project is sent to the next RMC meeting
• RMC feedback is sent to researchers by the Friday/Monday following each meeting

Expected timeframes for non-commercially sponsored trials:

• Receive RGO review within 14 working days of submission
• Once RGO deems submission complete and satisfactory, project is sent to the next RMC meeting
• RMC feedback is sent to researchers by the Friday/Monday following each meeting

Delays in answering RGO or RMC queries will result in an extended timeframe.

ERM training for Applicants, Sponsors and CROs

The Coordinating Office for Clinical Trial Research offers online ERM training for applicants, sponsors and CROs throughout the year.

The schedule for ERM training is distributed through the Coordinating Office’s Streamline eBulletin which outlines upcoming training sessions and information on how to register. Training occurs on either a Tuesday or Thursday each week from 2-4pm via Microsoft Teams. There are three training sessions:

• Introduction to ERM
• SSA Applications
• Post Approvals/Post Authorisations

To be added to the distribution list for the eBulletin, please email [email protected], or click here to view the most recent eBulletin.

You may also find the answers to your ERM questions here.

Annual Progress Reports

Take note of your HREC/SSA approval date. Your annual report is due every 12 months from this date for the life of your project.