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 Template - MS 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