Resources

The documents below are essential for any medical researcher working in Australia, WA and within the WA public health sector. It is also a requirement for researchers at CAHS to complete Good Clinical Practice Training prior to conducting any research activity.

Understand your broad responsibilities as a researcher in Australia:

• National Health and Medical Research Council, Australian Research Council and Universities Australia Australian Code for the Responsible Conduct of Research, 2018 (external site)

Understand how to design and conduct ethically acceptable research:

• National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research 2023 (external site)
• World Medical Association's Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects 2018 (external site)

Understand the fundamentals of conducting clinical trials and all human research:

• Therapeutics Goods Administration's Australian Clinical Trial Handbook (external site)
• Therapeutics Goods Administration's Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) annotated with TGA comments (external site)
• Good Clinical Practice online training available via Western Australian Health Translation Network (external site) – see below under GCP for more detail.
• Good Clinical Practice online training available via Global Health Training Centre (external site)
• WACHS has funded a WA membership for the Australian Clinical Trials Education Centre (A-CTEC) (external site) to enable all WA HSP researchers to access online training. Download the ACTEC training flyer (PDF).

Download the following templates for a CAHS clinical trial:

• Study Master File - table of contents guide (PDF)
• Study Start Checklist (Word)
• Signature and Delegation Log (Word)
• Screening Log (Word)
• Enrolment Log (Word)
• Eligibility Checklist (Word)
• Study Training Log (Word)
• Study Meeting Minutes Template (Word)
• HREC Self Audit Checklist (Word)
• Note To File Guidance (Word)
• Central Non-Compliance Log (Word)
• Site Non-Compliance Log (Word)
• Data and Safety Monitoring Board (DSMB) Charter Template (Word)

Understand how research is governed within WA Health:

• WA Health Research Governance Policy and Procedure (external site)
• For more information visit CAHS Research Governance and see content in the 'Essential reading and references' tab.

Understand the principles to ensure research is safe, respectful, responsible, high quality and of benefit to Aboriginal and Torres Strait Islander people and communities:

• National Health and Medical Research Council Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (external site)
• Western Australian Aboriginal Health Ethics Committee – AHCWA (external site)
• AIATSIS Code of Ethics (external site)

Follow available guidance on NHMRC requirements on safety reporting and monitoring requirements for Clinical Trials:

• Safety monitoring and reporting in clinical trials involving therapeutic goods (external site)
• Risk based management and monitoring of clinical trials involving therapeutic goods (external site)
• Reporting of serious breaches of GCP or Protocol in clinical trials involving therapeutic goods (external site)
• Data Safety Monitoring Boards (external site)

For information on ethical considerations in quality improvement (QI) and evaluation activities:

• NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities 2014 (external site)