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
Low and Negligible Risk Submission Checklist

Greater than Low Risk Submission Checklist
Ethics Application Cover Letter CRGH
Ethics Resubmission Application Cover Letter

Protocol Templates
Protocol template - Retrospective Data Collection Activities Only

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

Data Collection Forms
Data Collection Form for Multiple Source Data Collection

Data Collection Form for Single Soure Data Collection

Master Code Sheet
Master Code Sheet - CRGH version
Master Code sheet - RPAH version

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

Research Data Management Plan Template
SLHD RDMP template

Participant Information Sheet and Consent Forms (Including Opt-Out, Verbal Consent Templates and Plain Language Guides
Master Executive Summary Sheet (For Commercially Sponsored Clinical Trials only)
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 for Parents & Guardians
Master Consent Form for Parents & Guardians

Clinical Trials - Form for Withdrawal of Participation

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

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

Clinical Trial Only Forms
Indemnity Standard Form
Indemnity HREC Review Only
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 - 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)

Research Involving Ionising Radiation
Radiation Safety Report

Research Governance Forms
Site Specific Assessment Form (SSA)
SSA Head of Department Declaration
SSA Head of Supporting Department Declaration
Confidentiality Agreement
CTN Information Form

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

Post Approval Forms
Amendment Summary Sheet (or updated IB)
Change in Study Personnel Form

Reporting Forms:

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