Post-approval

Post-approval guidance

Please refer to our Guide to REGIS post approval and post authorisation for submission guidelines and requirements.

REGIS also offers users a variety of Quick Reference Guides (QRGs) and instructional videos to support in making submissions.

Amendments

Amendments requiring a corresponding HREC approval must receive HREC approval before submitting to the Research Governance Office. Amendments will not be authorised until HREC approval is granted.

General amendment

A general amendment includes:

Changes to the study protocol, including the conduct and/or design of the study.
Changes to any other study documentation (e.g. consent and recruitment material, study tools).
Any change that does not clearly fit in the provided amendment categories on REGIS.

Please ensure both tracked and clean versions of revised documents are uploaded onto the amendment form, ensuring that version numbers, dates of amended documents and filenames are updated and consistent.

Updated Investigator’s Brochure

Please email updated Investigator’s Brochure (IB), both clean and tracked, to the Research Ethics Office email if the updated IB does not trigger changes to the study documents. If changes are required to the study documents due to the updated IB, please submit a general amendment via REGIS.

Extension of HREC approval

Extensions less than 12 months

Please complete only the REGIS ‘Request for an extension of HREC Approval’ amendment form.

Extensions for more than 12 months

Please complete the SCHN HREC ethics renewal form alongside the REGIS ‘Request for an extension of HREC Approval’ amendment form and all other supporting documentation as per the SCHN HREC renewal form.

Addition of a new site

Users can enter multiple new sites within the one amendment form.

With the addition of a new site, a separate Site Specific Application (SSA or STE) must be completed for each site after the amendment is submitted to the HREC. If the study protocol includes the new participating sites, please include both a clean and tracked version of the protocol with the new site/s requested for added approval.

Change of CPI/PI/Administration

Any changes to the CPI or PI must be communicated to both the Research Ethics and Research Governance Offices. Change of administration personnel/other study investigators must be communicated to the Research Governance Office only. Please read more on changes to site investigators on the Governance post-authorisation page.

If a study team needs to change both the CPI and PI, then these requests need to be submitted independently of each other via two separate amendment forms within REGIS. Requests to change the administration contact, there is an option to 'add another' (i.e. multiple administration contacts within the same amendment form).

Progress/Final reports (Milestones)

Once research is approved, mandatory progress/final reports must be provided to both the Research Ethics and Governance Offices every year. In REGIS, progress/final reports are processed through 'Milestones'.

For projects migrated from the previous system (Online Forms), the appropriate progress/final reports may not have been created on REGIS. If this has occurred, please contact the Research Ethics Office for assistance.

Safety reporting

All clinical trials conducted in NSW have mandatory safety reporting requirements. All personnel involved in a clinical trial at SCHN must be familiar with the SCHN Policy: Clinical Trials Safety Reporting (page 7 provides clear guidance on safety event types and reporting pathways).

Significant Safety Issue

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.

SSIs are to be completed and sent to the HREC for all clinical trials (therapeutic goods and non-therapeutic goods).

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.

Reporting to Research Governance

Please note that if the SSI has occurred at one of the SCHN sites, please notify the Research Governance office via email as soon as possible and no later than 72 hours of the PI becoming aware of the SSI.

See the SSI notification form to be submitted to only the Research Governance office. See more on our Research Governance post-authorisation page .

Local safety events

Local safety events include the following:

A Suspected Unexpected Serious Adverse Event (SUSAR) in a medicines or biological trial.
An Unanticipated Serious Adverse Device Event (USADE) in a medical device trial.
An Unexpected and Related Serious Adverse Event (URSAE) in any other interventional trial.

Reporting to Research Governance

Local safety events are only reported to Research Governance office within 72 hours of the site becoming aware of the event.

See the SUSAR-USADE-URSAE notification form to be submitted to only the Research Governance office. See more on our Research Governance post-authorisation page .

Serious breaches

Previously known as protocol violations, a serious breach is defined as a breach of Good Clinical Practice or the protocol that is likely to have a significant impact on the:

Continued safety or rights of participants
Reliability of the data generated in the clinical trial.

Serious breaches must be reported to the HREC and Research Governance Office within 7 calendar days of confirming a serious breach has occurred. They are reported by the investigator to their institution, as they may impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.

Other

For all other types of study related correspondence (e.g. sponsor memos etc.), please email the Research Ethics Office.

Protocol deviations

Protocol deviations are minor administrative departures from HREC approved protocol which do not affect:

The scientific soundness of the research plan
The rights, safety, welfare of research participants

The reporting process for protocol deviations is completed by attaching a list of all protocol deviations to the progress/final report.