A NSW Government website


Forms and Templates

Initial Ethics Application Forms

Mandatory Requirements

Full HREC review

Expedited Review of Low and Negligible Risk (LNR) Research

Guidance to Completing the HREA

Ethical Considerations in Quality Improvement, Service Evaluation and Audit Activities

Clinical Case Reports

Access Request (See Research Governance)

Ethics Amendments

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)

Protocol Templates

Suggested Protocol Templates for Clinical Trials

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

Participant Information Sheets and Consent Forms

Annual Progress/Final Reports

In REGIS against your Ethics Application via Milestones

Annual Progress Reports and Final Reports

Safety Reporting

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