RPA RPA
Research Ethics and Governance Office

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 
Greater than Low Risk Checklist
LNR Checklist
Ethics Application Cover Letter RPAH
Ethics Application Cover Letter CRGH
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
RDMP Form

Protocol Templates
• Retrospective Data Collection Activities Only
Greater than Low Risk (excl. Clinical Trials)
Clinical Trials Protocol Template

 

Participant Information Sheet and Consent Forms (Including Opt-Out, Verbal Consent templates and Plain Language Guides

Information for Participants
Participant Consent Form
Information for Person Responsible 
Information for Parents & Guardians
Person Responsible Consent Form
Young Person Information Sheet
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

 

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

Biobanking Governance Templates
• 
Data Requistion Application Form Master template v1
• Biospecimen Data Requistion Application Form Master template v1
 
Clinical Trials Only Forms and Templates
Master Executive Summary
Indemnity Standard Form

Indemnity HREC Review Only
Clinical Trials Protocol Template
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
Child Consent Form - Child aged 16-17 years
Clinical Trials - Form for Withdrawal of Participation

Research Involving Ionising Radiation
Radiation Safety Report Form

Post-Approval Amendments
Protocol Amendment Form

Research Governance Forms
Site Specific Assessment Form (NSW SSA)
Privacy Undertaking Form
Student Code of Conduct
NSW Health Code of Conduct
• SSA Investigator Declaration Form
• SSA Investigator Details
• SSA Investigator Details and Declaration Form
• SSA Declaration (c)
• SSA Decalartion (b)
• SSA Authorisation by General Manager
• SSA Declaration by Academic Director (CPC-RPA Clinic only)
• SSA Principal Investigator Details
• CTN Information Form

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: June 2019) 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.