Ethics Post Approval Guidelines

Amendments to approved projects must be submitted via REGIS. 

To help expedite review, please note the following:

• All sections of the REGIS Amendment Form must be completed in detail, including a summary of the change and a detailed rationale/explanation for the change. Incomplete forms or those lacking sufficient detail may be returned to the applicant for completion
• All updated documents must be: 
  • Listed in the amendment form
  • Included with the submission in both tracked changed and clean versions
  • Have updated version number and date in the footer of each document (also please take care to update any other version/date on the document e.g. on the front of the study protocol.)

Please note the submission closing dates for the relevant committee meeting when submitting your amendment.

Change of study staff – only a change of PI or CPI needs to be submitted for ethical review (unless other personnel changes require an update to approved study documents - all document updates must be submitted for review).

IB Amendments must be submitted via REGIS as a general amendment using the instructions provided in the Quick Reference Guides. Please ensure a summary of changes is submitted which outlines what has changed in detail.

Please ensure this is submitted in REGIS as an Addition of New Site amendment.

Please provide the following for review:

• Full name of new site and the name of the nominated PI for that site within REGIS form
• PI details:
  • Brief CV  (2/3 pages) for new PI 
• Other documents as required, for e.g.: 
  • Revised protocol / PISCF etc
  • HREC Only Indemnity 
  • Radiation Safety Report from relevant site 
  • Victorian Specific Module (if Victorian site)
  • Western Australia Specific Module (if WA site)

Please ensure this is submitted in REGIS as a Change of CPI/PI amendment form.

Please provide the following for review:

• Details of incoming and outgoing CPI/PI within amendment form.
• Brief CV for new PI 
• Updated study documents as required.

Please note you may also use this form to add an Administration contact (this person will be copied on all REGIS correspondence). The form is actioned automatically upon submission and does not require review.

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.

What Next? 
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.

*Please note: 
 - 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.

Study Closure/Completion

Please submit a Milestone in REGIS. Please note the status definitions in the form. The study will not be closed in REGIS until a final report (status "Closed(post-analysis)" is submitted and noted).

Please ensure this is submitted in REGIS as a Request for extension amendment.

Please provide the following:

• Detailed rationale for the extension
• Amended documents as required

Please submit your application for an extension at least 3 months prior to expiry of current ethical approval.   

Safety reports must be submitted in accordance with Safety Reporting Guidelines

The NSW OHMR formally endorses the updated NHMRC Safety Reporting Guidance with Policy Directive (PD2017_039) titled 'Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations'. 

SESLHD HREC and Research Governance follow the NSW Health Policy Directive: Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations (attached).

The following safety related items should be submitted:

• Significant Safety Issues (SSI) (submitted via REGIS)
• Annual Safety Report (often the Executive Summary of the DSUR serves as the annual safety report. This can be submitted with your REGIS annual report or at any other time)

SESLHD HREC do not require the following reports: 

• Single case AEs, SAE/SARs and SUSARs (or device/non-therapeutic good trial equivalents)
• Six monthly line listings.

Serious Breaches from GCP or the Protocol

Good Clinical Practice (GCP) requires all deviations to be reported to the trial sponsor. Sponsors have primary responsibility for determining whether any suspected breach meets the definition of a serious breach. Serious breaches are the small sub-set of deviations that have a significant impact on the continued safety or rights of participants or the reliability and robustness of the data generated in the clinical trial.

Report to SESLHD HREC

• All serious breaches within 7 calendar days of confirming the breach has occurred (See REGIS guide on reporting).
• Follow up reports when required

Do not report to SESLHD HREC or RGO

• Protocol deviations that do not meet the definition of a serious breach (Sponsors have primary responsibility for determining whether any suspected breach meets the definition of a serious breach).

See Guideline: NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods. 

NSW PHO Sponsor

When the sponsor is a NSW PHO, it may delegate some or all sponsor functions to the Coordinating Principal Investigator (CPI) or other third party (e.g. a coordinating centre). When CPIs are delegated sponsor functions, they would undertake both the investigator and sponsor responsibilities described in the Policy Directive (PD2017_039) 'Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations'.

Policies and 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