A general site 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.

For an efficient general site amendment review, it is important to note the following information:

• Explain what changed in the project and why (ensure to include the Ethics form ID and any relevant documents).
• Summary of site implications, clearly stating how the changes in this amendment will affect the conduct of the study at the SCHN site.
• Ensure all the required updated site specific documentation is included for approval.
• If the HREC is outside of REGIS, ensure all documentation has the corresponding HREC approval letters uploaded with the amendment submission.

Please see our contracts and agreements page for what information is required for research related agreement review.

Any changes or updates to contracts/agreements for authorised research projects need to be submitted as an amendment via REGIS. A site amendment is not necessary for Certificate of Currency/Insurance renewal (see more under Progress/Final reports).

 Please follow these steps when updating contracts/agreements:

1. Complete the site amendment form in REGIS. Fill out all the necessary information, providing details about the amendment being proposed. This information encompasses the nature of the update, the rationale behind it and any relevant context (e.g. update to the study budget).
2. Tracked changes agreement in Word format. Include a tracked change version of the agreement in Microsoft Word format as an attachment with your REGIS amendment submission.
3. Clean version of the agreement. Include a clean and updated version of the agreement as an attachment with your REGIS amendment submission.

Please note the reviewing Research Governance Officer will be in touch if further information is required.

Please note a change of site investigator amendment submission is required to Research Governance when:

• There is a change of SCHN site Principal Investigator.
• There is a change of Associate Investigator or Sub-Investigator (AI/Sub-I).
  • An AI/Sub-I is defined as any individual member of the study team at the SCHN site (this can include non-SCHN employees and students on ClinConnect), designated and supervised by the site Principal Investigator, to perform significant study-related procedures and/or delegated to make important study-related decisions.
• If the addition of site investigators includes any study personnel that are non-SCHN employees please refer to the Contingent Worker Approval guide for further information.

Please note it is the responsibility of the site PI to ensure that relevant departmental approvals have been received for the addition of new personnel joining a study.

When Ethics approval is through REGIS, a Governance Milestone is not created for a progress report. When approved/achieved by Ethics, it is shared with each site in REGIS. If the Research Governance Office requires further information, the PI will be notified.

If a research project was granted Ethics approval from a HREC not through REGIS, the process for progress/final reports has the CPI submit the progress/final reports to their relevant HREC as per their guidelines. The SCHN site PI is responsible for submitting the progress/final report to the Research Governance Office via REGIS.

This milestone is only created when the study is a Clinical Trial. It is a report of the date the first patient or participant was enrolled into a clinical trial, consented, and screened with eligibility verified.

The SCHN site PI is responsible for submitting the first patient in report via REGIS.

This milestone is only created when the study is a Clinical Trial. It must be submitted as evidence of current professional indemnity and products liability policy/s, or equivalent, and must include clinical trials cover. Please ensure the updated insurance certificate complies with the NSW Ministry of Health Policy Directive.

The SCHN site PI is responsible for submitting the Certificate of Currency (CoC)/Insurance renewal via REGIS.

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.

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. 

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.

Local safety events are 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.