Annual progress reports
Researchers must submit annual progress reports on the due date specified on the HREC approval letter. A final progress report must also be submitted upon study completion. The Annual and/or Final Progress Report Template can be found here.
Submissions will also be reviewed by the Research Governance and Ethics Officer, and referred for further governance review as appropriate.
For more information, go to Resources and contact the Research Governance and Ethics Officer.
Protocol deviation and protocol violation reports
Researchers must submit reports detailing any protocol deviation or protocol violation to the HREC in a timely matter, with an explanation of how the deviation or violation occurred and what action has been taken to ensure the error will be avoided in the future. This report should be addressed to the HREC Chair, c/o Research Governance and Ethics Officer.
Safety monitoring and reporting for clinical trials
As of October 3, 2017, the NSW Office of Health and Medical Research (OHMR) have formally accepted the updated NHMRC Safety Reporting Guidance. This will now align with national and international standards. This is effective now, and applies to new and existing trials.
Further information can be found at: http://www.health.nsw.gov.au/ethics/Pages/safety-reporting.aspx
A summary of Safety Notifications and Safety Reporting Pathways for all trials can be located at: http://www.health.nsw.gov.au/ethics/Pages/safety-pathways.aspx
Frequently Asked Questions (FAQs) can be found at: http://www.health.nsw.gov.au/ethics/Pages/safety-faq.aspx
The new policy titled Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations (PD2017_039) can be found at: http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2017_039.pdf
What changes to reporting requirements have been made?
Fewer reports are required, and all safety reporting to the Human Research Ethics Committee (HREC) and/or Research Governance and Ethics Officer (RGEO) is the responsibility of the sponsor of the trial.
HRECs will no longer receive: Single case AEs, SAE/SARs and SUSARs or device/non-therapeutic good trial equivalents or six monthly line listings.
HRECs will receive: all significant safety issues, annual safety reports and investigator's brochure updates. Significant safety issues can be reported in the Significant Safety Issue Form (the use of which is mandated by OHMR). Annual Safety reports can be reported in the Annual Progress Report, on the sponsor's template or in the form of the most recently updated Investigator's Brochure or DSUR/DSMB report
The Significant Safety Issue Form (SSI) can be found on the OHMR Safety Reporting Webpage: http:// www.health.nsw.gov.au/ethics/Pages/safety-reporting.aspx
- A significant safety issue (SSI) is a safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
- If an SAE/SAR/SUSAR meets the definition of an SSI, it will be reported to the HREC/RGEO through that reporting mechanism.
- SSIs that have been implemented as an urgent safety measure* should be reported within 72 hours of the sponsor becoming aware of the issue.
- All other SSIs should be reported within 15 calendar days of the sponsor becoming aware of the issue.
- A measure required to be taken in order to eliminate an immediate hazard to a participant's health or safety.
RGEOs will no longer receive: Single case AEs, SAE/SARs and external SUSARs or device/non-therapeutic good equivalents or six monthly line listings.
RGEOs will receive: All significant safety issues (SSIs), any local SUSARs/USADEs/URSAEs and any research-related events that meet the definition of an incident.
Local SUSARs/USADEs/URSAEs can be reported in the Local SUSAR/USADE/URSAE Notification Form (the use of which is mandated by the OHMR).
http://www.health.nsw.gov.au/ethics/Pages/safety-reporting.aspx
In trials where Justice Health & Forensic Mental Health Network (JH&FMHN) is the sponsor the sponsor's reporting responsibility is delegated by the JH&FMHN Chief Executive to the Coordinating Principal Investigator or Principal Investigator.
It is the responsibility of the CPI/PI to ensure compliance with NHMRC and OHMR policy and guidance.
Where the sponsor is another entity- for example, a University, you should seek guidance from that institution. It is likely that the delegation will be to the Principal Investigator.
Contact
For further advice and information about the safety monitoring and reporting, please contact Josie Cullen, Research Governance and Ethics Officer on ethics@justicehealth.nsw.gov.au or the Office of Health and Medical Research on researchethics@doh.health.nsw.gov.au.