​CCLHD forms and supporting documentation

​ CCLHD – Research – Where to Start (399 KB)

CCLHD – Application Checklist Clinical Practice Improvement, Quality Improvement & Research (652 KB)

CCLHD – Clinical Trial Budget Proforma (30 KB)

CCLHD – Research Indemnity Assessment Form (408 KB)

CCLHD – Site Specific Assessment – Amendment Application Form (508 KB)

CCLHD – Site Specific Assessment – Change in Personnel Form (487 KB)

CCLHD – Site Specific Assessment – Low/Negligible Risk- Checklist (352 KB)

CCLHD – Site Specific Assessment – Low/Negligible Risk – Flowchart (357 KB)

CCLHD – Site Specific Assessment – National Ethics Application Form – Checklist (457 KB)

CCLHD – Site Specific Assessment – National Ethics Application Form – Flowchart (357 KB)

CCLHD – Standard Budget Proforma (163 KB)

Standard Medicines Australia and TGA documents

 Clinical Trial Research Agreement – Standard Form

 Clinical Trial Research Agreement – Contract Research Organisation acting as the Local Sponsor

 Clinical Trial Research Agreement – Collaborative or Cooperative Research Group

 Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines)

 Template to Request a Schedule 7 or Schedule 4 Variation to a Clinical Trial Research Agreement

 Form of Indemnity – Standard

 Form of Indemnity – HREC Review Only

 Notification of intent to supply unapproved therapeutic goods under the clinical trial notification (CTN) scheme

 Notification of intent to supply unapproved therapeutic goods under the clinical trial exemption (CTX) scheme

Legislation and guidance

 Australian Code for the Responsible Conduct of Research

 Department of Health and Ageing’s Health Technology Assessment (HTA) Website

 Human Tissue Act 1982

 National Statement on Ethical Conduct in Human Research (2007)

 NSW Health Ethics and Research Governance

 NSW Health Forms and Resources

 National Statement on Ethical Conduct in Human Research (2007)

 Human Research Ethics Committees, Quality Improvement & Ethical Review: A Practice Guide for NSW (PDF)

 When does Quality Assurance in Health Care Require Independent Ethical Review?

 NSW Health Privacy Manual (2005) (PDF)

 National Privacy Principles

 Privacy Act 1988

 Standard Medicines Australia Forms of Indemnity and Compensation Guidelines

 World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects