Forms and Templates

Mandatory Requirements

• All New Ethics Applications must be submitted in REGIS.
• The Mandatory Checklist for New Ethics Submissions must be completed and uploaded as a new document in your HREA for all research/all review pathways.

Full HREC review

• HREA (ETH) via REGIS (All new applications)
• QRG – Completing an ethics application
• Mandatory Checklist for New Ethics Submissions (complete and upload as a new document in your HREA).

Expedited Review of Low and Negligible Risk (LNR) Research

• HREA (ETH) via REGIS (All new applications)
• QRG – Completing an ethics application
• Mandatory Checklist for New Ethics Submissions (complete and upload as a new document in your HREA).

Guidance to Completing the HREA

• Guidance to Completing the Human Research Ethics Application

Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities

• Checklist: Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities

Clinical Case Reports

• HNELHD Clinical Case Report Application Form
• Case Report Consent Template

Access Request (See Research Governance)

Amendment form in REGIS

A Notification of an Amendment to a Research Study is to be completed in REGIS against your Ethics Application.

There are 4 amendment types:

1. General Amendment

Affecting the conduct, design or methodology of a trial and includes changes to:

• Information previously given in the HREA
• The Protocol
• The Information sheet(s) and consent form/s for participants
• Any other supporting documentation for the study

2. Request for an extension of HREC Approval

Approval to extend the project beyond the original period granted by the HREC
(NOTE: For requests of over 12 months you should contact the Research Office first, as a full re-submission may be required)

3. Addition of a Site

Update the study details of the additional site(s) and investigator(s)
(NSW sites will have a site application form generated in REGIS)

4. Change to CPI/PI
Notify the HREC of changes to the Coordinating Principal Investigator and/or Site Principal Investigator(s)

• QRG – Ethics Amendment – Completing & Submitting
• Ethics Amendment Submission Checklist (under development)

Suggested Protocol Templates for Clinical Trials

• SPIRIT
• TRANSCELERATE
• EQUATOR

Suggested Protocol Templates for Non Clinical Trials (including Biological Studies and Data Studies)

• Non Clinical Trial Protocol Template

[NEW] Templates for Participant Information Sheets (PIS) and Consent Forms

The CT:IQ InFORMed Project launch has developed templates and user guides for simplified Participant Information Sheets for use by researchers. We encourage researchers to use these resources.

• CT:IQ InFORMed: Redesigning Consent to Research User Guide

Information Statements and Consent Form Templates

• Guidance for Participant Information Statements and Consent Forms
• Master Executive Summary
• Master Participant Information Statement
• Master Participant Consent For
• Master Parent/Guardian Information Sheet
• Master Parent/Guardian Consent Form
• Master Child Information Statement 8-12 years
• HNE Complaint Statements for Participant Information Statements

In REGIS against your Ethics Application via Milestones

Annual Progress Reports and Final Reports

• Milestone Report (Annual Report) via REGIS
• QRG – Submitting a Progress/Final Report

In REGIS against your Ethics Application via Forms

• Significant Safety Issues (SSI's) in REGIS
• Serious Breach Notification (third party) in REGIS
• Reporting Local Safety Events to the Institution in REGIS
• Annual Safety Reports (in REGIS via a General Amendment or an Annual Progress Report)
• Updated Investigator Brochures via a General Amendment in REGIS

QRG - Submitting a Clinical Trial Safety Report