Forms and Templates

Human Research

For more information on submission guidelines and required documentation when submitting a new proposal, please refer to the "How to apply" page for:

1. Ethics - non-clinical trials research studies incl. low risk studies
2. Ethics - clinical trials
3. Site Specific Applications

Submitting your study through REGIS

Ethics Templates
• Sample HREA for Medical Record Research (incl. Guidance Notes)

Checklists and Cover Letters
• Clinical Trials Checklist 
• Ethics Checklist for Non-Clinical Trials (Greater than low risk & Low risk studies)
• Ethics Application Cover Letter RPAH
• Ethics Resubmission Application Cover Letter

Data Collection Forms
• Data Collection Form for Multiple Source Data Collection
• Data Collection Form for Single Data 

Master Code Sheets
• RPAH Office version
• CRGH Office version 

 Privacy Compliance Form
• Privacy Compliance Form

Research Data Management Plan Template
• SLHD RDMP Template - MS Word Version here 

Protocol Templates
• Low or Negligible Risk Studies
• Low or Negligible Risk Retrospective Medical Record Studies
• Greater than Low Risk (excl. Clinical Trials)
• Clinical Trials Protocol Template
• Protocol Template Establish Database / Clinical Registry Database
• Protocol Template Interviews / Focus Groups / Surveys
 

Conflicts of Interest and Management Plan Temaplate
• Conflicts of interest and management plan template

Social Media Plan Templates
• Social Media Plan Templates

Participant Information Sheet and Consent Forms (Including Opt-Out, Verbal Consent templates and Plain Language Guides
• Participant Information Sheet
• Participant Consent Form
• Information for Person Responsible 
• Person Responsible Consent Form
• Information for Participants (Database)
• Participant Consent Form (Database)
• Participant Information Statement (Opt-Out),including Opt-Out Form 
• Information for Participants and Consent Forms (Tissue bank/Genetics)
• Verbal Consent form - option 1
• Verbal Consent form - option 2
• Plain Language Guide - Medical Term
• Plain Language Guide - General
• Young Person Information Sheet
• Participant Information Sheet - Parent Guardian Template
• Young Person Consent Form (16-17 years)
• Parent Guardian Consent Form
• Master Child Information Sheet and Consent Form

Note: Please note that the link for the Child PISCF will direct you to the Sydney Children’s Hospital Network (SCHN) Research Ethics and Governance website. If submitting an application to the SLHD HREC that is recruiting children, please use the SCHN Child PISCF template. No other templates will be accepted by the SLHD HREC. 


Other templates – Letters of Invitation Expressions of Interest (EOI), Case Study Forms, Advertising/ Recruitment, Telephone Scripts
• Invitation from Medical Officer
• Expressions of Interest
• Case Study PIS - CF
• Advertising/Recruitment Templates
• Telephone Script Template
• Telephone Flowchart for Recruitment Template
• Interview Guide Template

Biobanking Governance Templates
• Data Requistion Application Form Master template v1
• Biospecimen Data Requistion Application Form Master template v1
 
Clinical Trials Only Forms and Templates
• Consumer Engagement Plan Template
• Master Executive Summary
• Indemnity Standard Form
• Indemnity HREC Review Only
• DSMB Checklist
• DSMB Sample Agenda template
• Victorian Specific Module
• Western Australia Specific Module
• Information for Participants and Consent Form - Self (Interventional)
• Information for Participants and Consent Form - Parent and Guardian (Interventional)
• Information for Participants and Consent Form - Person Responsible (Interventional)
• Information for Participants and Consent Form - Self (Health and Social Science)
• Information for Participants and Consent Form- Parent and Guardian (Health and Social Science)
• Information for Participants and Consent Form - Person Responsible (Health and Social Science)
• Assent Form for Children Aged 10-13 years old
• Young Person Consent Form (16-17 years)
• Clinical Trials - Form for Withdrawal of Participation

Research Involving Ionising Radiation
• Radiation Safety Report Form

Research Governance Forms
• Site Specific Assessment Form (NSW SSA)
• Privacy Undertaking Form
• Student Code of Conduct
• NSW Health Code of Conduct
• Notification of Change in Personnel  & Privacy Undertaking Form
• SSA Declaration by Academic Director (CPC-RPA Clinic only)
• SSA Investigator Details
• CTN Information Form
• Research Governance Submission Checklist for Researchers
• Consumer Engagement Plan Template RGO
• Research Proposal Template for the Head of Department
• Instructions for site-specific PISCF documents - including new PREMS wording (updated 17 September 2024)

Reporting Forms
Safety Reporting and Monitoring Forms 
• Significant Safety Issue (SSI) notification form
• SUSAR/USADE/URSAE reporting form

Animal Ethics

For more information on submission guidelines and required documentation when submitting a new proposal, please refer to How to apply.

• The Application and other forms (Version: Feb 2023) are available from the office. 

Biosafety

For information on how and when to apply and for guidelines please refer to the How to apply page.