Resources

​CCLHD forms and supporting documentation

 

PDF Document CCLHD – Research – Where to Start (399 KB)

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

PDF Document CCLHD – Clinical Trial Budget Proforma (30 KB)

PDF Document CCLHD – Research Indemnity Assessment Form (408 KB)

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

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

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

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

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

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

PDF Document CCLHD – Standard Budget Proforma (163 KB)

Standard Medicines Australia and TGA documents

External page link Clinical Trial Research Agreement – Standard Form

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

External page link Clinical Trial Research Agreement – Collaborative or Cooperative Research Group

External page link Clinical Trial Research Agreement – Phase 4 Clinical Trial (Medicines)

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

External page link Form of Indemnity – Standard

External page link Form of Indemnity – HREC Review Only

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

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

Legislation and guidance

External page link Australian Code for the Responsible Conduct of Research

External page link Department of Health and Ageing's Health Technology Assessment (HTA) Website

External page link Human Tissue Act 1982

External page link National Statement on Ethical Conduct in Human Research (2007)

External page link NSW Health Ethics and Research Governance

External page link NSW Health Forms and Resources

External page link National Statement on Ethical Conduct in Human Research (2007)

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

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

External page link NSW Health Privacy Manual (2005) (PDF)

External page link National Privacy Principles

External page link Privacy Act 1988

External page link Standard Medicines Australia Forms of Indemnity and Compensation Guidelines

External page link World Medical Association (WMA) Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects