Governance Post Approval Guidelines
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 the SESLHD Research Office via REGIS.
Translation of Findings into Clinical Practice
SESLHD supports the translation of positive research findings into clinical practice and provides additional governance oversight via the following pathways:
- The Quality Use of Medicines Committee (QUMC) - The QUMC provides leadership for medication management across SESLHD and provides a pathway for the endorsement and approval of medication usage via the SESLHD Clinical & Quality Council as detailed in SESLHDPR/267.
- New Interventions and Procedures Process (NIAP) - The NIAP provides a standard process by which new procedures, technologies and treatments can be assessed and approved. Further information about the process can be found here.
- Business case submission to the site General Manager - proposals that don't fall within the scope of the QUMC or NIAP should be submitted to the site General Manager using the Business Case template available on the SESLHD intranet.
For further guidance on the above pathways, contact the Research Office via SESLHD-RSO@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 Office 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 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
Submission of annual progress reports and final reports (milestones) to SESLHD Human Research Ethics Committee (HREC) and Research Governance (RGO).
A reminder regarding the submission of annual progress reports and final reports (milestones) to SESLHD HREC and RGO.
This information is adapted from REGIS Quick Reference Guides which are available on the REGIS website.
What is a Progress/Final Report?
It is a standard condition of HREC (Ethics) approval that an annual progress report is submitted for review by the approving HREC. REGIS jurisdictions have introduced streamlined annual reporting. Researchers are required to fill out a single report form to the HREC and NSW sites. In REGIS, progress and final reports are processed through Milestones.
Who should submit the progress report?
The Coordinating Principal Investigator (CPI) has the overall responsibility of the study. The CPI can also delegate ‘submit access’ to anyone with a REGIS account. This does not remove the overall responsibility from the CPI. The CPI OR their delegate(s) can submit the progress report to the HREC. Please see reference guide or instructional video.
Once the Progress report has been accepted by the HREC the system will share the report with all NSW authorised sites. You will not have to submit any further documents to any NSW sites. The email notification now acts as a HREC and NSW RGO acknowledgment of annual reporting requirements being met. NSW site RGO’s will only contact you if they require further information. For sites outside of REGIS you may need to submit the report separately.
What if my HREC is external to REGIS?
When Ethics is outside of REGIS and is being managed in another jurisdiction, the HREC approved annual progress reports must be submitted as a governance/site milestone. This milestone must be created by the research office. REGIS allows for a single submission to all NSW authorised sites. The PI and their delegate(s) can submit the Progress Report – External HREC. Please see reference guide available.
When the Progress Report – External HREC milestone is processed by the Research Governance Office (RGO), the status of the milestone changes to ‘Achieved’. You will only be notified if more information is required.
- For annual/final reports being submitted directly to RGO (where the HREC is external to REGIS) the Research Office must create the site milestone.
REGIS has the functionality to allow a single form to be submitted on behalf of all sites in REGIS (preferred). By selecting “Yes” to the question ‘Is this report for all sites in REGIS?’, you will be presented recruitment questions for all of the authorised sites in NSW. On submission, a copy of this form will be sent to each relevant RGO. Select “No” to be presented with questions for your local site only. This form will only be sent to your RGO.
- For migrated studies (studies that commenced prior to REGIS and were migrated onto the REGIS system in 2019) all progress/final reports must be created by the research office. Please contact the relevant research office.
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