Post Approval Governance
Study changes that are made after ethics approval and site authorisation must be reviewed and approved by the Lead HREC. Approved changes must then be notified to SESLHD Research Ethics and Governance via REGIS.
NSW Health has provided a Guidance Document for Clinical Trials.
Protocol and GCP breaches are expected in light of the unprecedented situation being faced by health services. All significant safety issues must be reported as per standard practice however non-serious breaches may be reported retrospectively in a single post COVID-19 deviation report.
The deviation report will require a summary to be provided to the site RGO on:
For further guidance please refer to the linked document in the first instance, then contact clinicaltrialsNSW@health.nsw.gov.au.
- Protocol Amendments – Changes to approved protocols that are administrative, scientific or logistical must be notified.
- IB Amendments – Changes to the Investigator Brochure for a drug or device must be notified. The changes will be acknowledged and noted.
- Amendments to the Participant Information Sheet and Consent Forms (PISCF) – Changes that do not affect non-SESLHD sites do not require HREC review unless related to Protocol or IB amendments.
- Changes to study personnel – HRECs will review changes to the Principal or Coordinating Investigator however notifications to Research Governance are required for all personnel changes to ensure insurance coverage.
- Research agreement changes – The Research Ethics and Governance team will facilitate re-execution of agreements where necessary.
- Study title changes – Although this is a minor change it requires changes to all study documents, research agreements, indemnities and notification to the TGA if necessary.
All amendments must be submitted via REGIS. Please use the Quick Reference Guides and tutorials available on the REGIS website for guidance.
Amendment requests must include:
- The HREC approval letter
- Revised study documents as listed on the HREC approval letter
- For contract revisions, a copy of the updated contract signed by the PI and Sponsor.
Progress and Final Reports are to be submitted to the Lead HREC. The report and the HREC acknowledgement letter must then be submitted to Governance via REGIS.
Commercially sponsored clinical trials require insurance to be renewed annually. New certificates of currency need to be submitted via REGIS.
The NSW Office for Health and Medical Research requires NSW Health sites to collect metrics relating to participant recruitment to commercially sponsored clinical trials.
REGIS will automatically generate a first patient in milestone. Please complete this and detail:
- The date the first participant was recruited, if not within 40 calendar days please provide a brief reason
- If the study has not yet recruited, please provide a brief reason for not reaching the enrolment target.
Significant Safety Issues and SUSAR/USADE/URSAE safety reports must be submitted in accordance with safety report guidelines via REGIS.
The NSW OHMR has endorsed the NHMRC Safety Reporting Guidance and has published 'Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations'.
For further details please refer to the OHMR website.
All safety reporting to the HREC and/or Research Governance Officer (RSO) is the responsibility of the Sponsor of the trial.
The OHMR has mandated the use of the forms below:
- Significant Safety Issue (SSI) Notification Form (reporting from the Sponsor to the HREC)
- SUSAR/USADE/URSAE Notification Form (reporting from Local Investigator to the local RGO).
RGOs will receive:
- local SSIs;
- local SUSARs/USADEs/URSAEs; and
- any research-related events that meet the definition of an incident.
Report all local SUSARs/USADEs/URSAEs in the Local SUSAR/USADE/URSAE Notification Form.
*Note: If a SAE/SAR/SUSAR meets the definition of an SSI, it will be reported to the HREC/RGO through that reporting mechanism.
In trials where SESLHD is the sponsor, the sponsor’s reporting responsibility is delegated by the SESLHD CE 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 you should seek guidance from that institution. It is likely that the delegation will be to the Principal Investigator.
Please also see the following policies/guidelines for further information:
- Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
- Guidance: Safety monitoring and reporting for clinical trials
- Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.