Concord Hospital Concord Hospital
The Concord Research Office

Forms and Templates

Human Research

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

Submitting your study through REGIS.

Ethics Templates
Sample HREA for a Retrospective Medical Record Audit (inc. guidance notes)

Checklists and Cover Letters
Ethics Non-Clinical Trials Submission Checklist (Greater than low risk & Low risk studies)

Clinical Trials Submission Checklist
Ethics Application Cover Letter CRGH

Ethics Resubmission/Extension Request Application Cover Letter

Protocol Templates
Protocol template - Low or Negligible Risk Studies

• Protocol template - 
Low or Negligible Risk Retrospective Medical Record Studies
• Protocol template - Establishment of a Database / Clinical Registry Database
• Protocol template - Interviews / Focus Groups / Surveys

• Protocol template - Greater than Low Risk (exc. Clinical Trials)
Clinical Trials Protocol Template

Conflicts of interest and managemant plan template
• Conflicts of interest and management plan template

Social media plan template
• Social media plan template

Data Collection Forms
Data Collection Form for Multiple Source Data Collection

Data Collection Form for Single Source Data Collection

Master Code Sheet
Master Code Sheet

Privacy Form
• Privacy Compliance Form (For arguing waiver of consent)
 - MS Word version here

Research Data Management Plan Template
SLHD RDMP TemplateMS Word Version here

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

• Master Information for Participants 
• Master Participant Consent Form
• Master Information for Person Responsible
• Master Person Responsible Consent Form 
• Master Information for Participants (Database)
• Master Participant Consent Form (Database)
• Master Participant Information Statement (Opt-Out), including Opt-Out Form
• Master Information for Participants and Consent Forms (Tissue bank/Genetics)
• Verbal Consent Form - Option 1
• Verbal Consent Form - Option 2
• Plain Language Guide - Medical Terminology
• Plain Language Guide - General

 Master Young Person Information Sheet
• Master Information Sheet for Parents & Guardians
Master Consent Form for Young Person (16-17 years)
• Master Consent Form for Parents & Guardians
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. 

Note: The Sydney Local Health District HREC – CRGH will review single-site (CRGH-only) research which involves children. However, the HREC is not certified by the NHMRC to undertake review of multi-centre research involving children. Multi-centre research submissions should be referred to a lead HREC which is certified to review research involving children, such as the Sydney Children's Hospitals Network Human Research Ethics Committee or the Sydney Local Health District Ethics Review Committee – Royal Prince Alfred Hospital.

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

Biobanking Governance Templates
• Biospecimen Data Requisition Application Form
• Data Requisition Application Form

Clinical Trial Only Forms

• Master Executive Summary Sheet (For Commercially Sponsored Clinical Trials only)

• Indemnity Standard Form
• Indemnity HREC Review Only

• Clinical Trials Protocol Template
• DSMB Checklist
• DSMB Sample Agenda Template
• Victorian Specific Module
• Western Australia Specific Module
• Master Information for Participants and Consent Form - Self (Interventional)

Master Information for Participants and Consent Form - Parent and Guardian (Interventional)

Master Information for Participants and Consent Form - Person Responsible (Interventional)
• Master Information for Participants and Consent Form - Self (Health and Social Science) 
• Master Information for Participants and Consent Form - Parent and Guardian (Health and Social Science)
• Master 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

Consumer Engagement Plan

Research Involving Ionising Radiation
Radiation Safety Report

Research Governance Forms
Site Specific Assessment Form (NSW SSA)

CTN Information Form
• Notification of Change in Personnel and Privacy Undertaking Form

Privacy Undertaking Form

Research Proposal template for Head of Department

Research Governance Submission Checklist for Researchers

Consumer Engagement Plan

Guidance Documents and Forms
Genetic Research Checklist
Guidelines for Compensation
Scientific Review Checklist

Reporting Forms:

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