Reporting Requirements
Annual and Final Reporting
The National Statement on Ethical Conduct in Human Research 2023, which the Hunter New England Human Research Ethics Committee is obliged to adhere to, include the requirement that the Committee monitors the research protocols it has approved. In order for the Committee to fulfill this function, it requires:
- A report of the progress of the protocol to be submitted at 12 monthly intervals. The Annual Progress Report must be submitted in REGIS. The Coordinating Principal Investigator will receive upcoming and overdue reminders from REGIS.
- A final report be submitted at the completion of the protocol, that is, after data analysis has been completed and a final report compiled. The Final Report must be submitted in REGIS.
In REGIS against your Ethics Application via Milestones
Annual Progress Reports and Final Reports
- Milestone Report (Annual Report) in REGIS
- QRG – Submitting a Progress/Final Report
Safety Reporting
As of January 2018 the Hunter New England Local Health District has adopted the NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods https://www.nhmrc.gov.au/guidelines-publications/eh59
In line with these guidelines the safety reporting requirements for the Hunter New England Research Ethics and Governance Office is as follows.
For Commercial Sponsored Trials
See the following link http://www.health.nsw.gov.au/ethics/Pages/safety-pathways.aspx
REGIS Safety Reporting Forms
- Significant Safety Issues (SSI's) in REGIS
- Serious Breach Notification (third party) in REGIS
- Reporting Local Safety Events to the Institution in REGIS
- Updated Investigator Brochures via a General Amendment in REGIS
- Annual Safety Reports in REGIS via a General Amendment or attached to the Annual Progress Report Milestone
For Non Commercial Sponsored Trials
REGIS Safety Reporting Forms
- Significant Safety Issues (SSI's) in REGIS
- Serious Breach Notification (third party) in REGIS
- Reporting Local Safety Events to the Institution in REGIS
- Updated Investigator Brochures via a General Amendment in REGIS
- Annual Safety Reports in REGIS via a General Amendment or attached to the Annual Progress Report Milestone