Useful resources and training forms for ethics and governance

Forms 

New applications 

• Human Research Ethics Application (HREA) 
• Western Australian Specific Module (WASM) 
• Clinical Trials Notification (CTN) 
• HREC Radiation Notification Letter 
• Site Specific Assessment (SSA) Application 

Post approval 

• Amendment Request Form
• Declaration by Head of Supporting Department Form
• Safety Report
• Annual Safety Report Form
• Serious Breach Report Form (Sponsor)
• Suspected Breach Report Form (Third Party)
• Progress Report - Project Form (HREC)
• Progress Report - Site Form (RGO)
• Project Final Report Site Closure Report Form
• Research Project Complaint Report

Standard Operating Procedures

• SOP001 Ethical Review - Human Research
• SOP002 Peter Mac Governance Review Requirements for Human Research
• SOP003 Clinical Research Project Queries/Complaints
• SOP004 Monitoring of Ongoing Research
• SOP006 Safety Reporting

Training 

Good Clinical Practice (GCP) Training Requirements 

It is a requirement of the Australian Therapeutic Goods Administration (TGA), the US Food and Drug Administration (FDA) and European Regulators that Principal Investigators (PIs), Associate Investigators (AIs) and other trial coordination staff undergo recognised Good Clinical Practice (GCP) training to conduct clinical trials. 

Peter Mac staff must comply with Peter Mac Clinical Research: Mandatory Training and Compliance policy

• All current Principal Investigators and Associate Investigators on prospective interventional studies have successfully completed GCP training and hold a current GCP certificate (valid for three years)
• All staff on delegation logs undertake accredited GCP training appropriate to their role and delegation
• Where appropriate, all researchers on other human research projects undertake GCP training (per Peter Mac Clinical Research: Mandatory Training and Compliance policy)

To obtain your GCP certification, staff are recommended to visit the Australian Clinical Trials Education Centre (ACTEC) website and complete the online “Good Clinical Practice (GCP) = Good Research Practice” course.  This course is mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R2) GCP.  It is free of charge to all registered participants.

Ethics and Governance 

If you or your department is interested in receiving training on ethics and governance topics, please contact us using the details at the bottom of this page.

Other Recommended Training

Further information regarding recommended training for Peter Mac Investigators can be found here: New Governance Application - Peter MacCallum Cancer Centre (see Investigator Training Requirements).

Ethics Committee and Sub-committees

The Peter MacCallum Cancer Centre Ethics Committee [EC00235] is constituted and operates according to the National Statement on Ethical Conduct in Human Research. The NHMRC certifies it as a reviewing Human Research Ethics Committee (HREC) for multicentre ethical review of human research in oncology.

The Peter MacCallum Cancer Centre Ethics Committee's primary roles are to:

• Review and, as appropriate, approve or reject human research projects submitted by affiliated and non-affiliated researchers  
• Consider matters arising from the conduct of approved human research projects

The Clinical Research Committee, Tissue Research Committee and Out of Session Panel supports the Ethics Committee to ensure adequate expertise for the evaluation of research. 

The Ethics Committee also delegates the review of lower risk research to the Lower Risk Research Ethics Committee and the Divisional Review Panels.

Terms of reference:

• Human Research Ethics Committee
• Clinical Research Committee
• Tissue Research Committee
• Lower Risk Research Ethics Committee
• Out of Session Review Panel
• Divisional Review Panels

Useful Resources 

The Basics 

• National Statement on Ethical Conduct in Human Research 
• Australian Code for the Responsible Conduct of Research and supporting guides 
• Therapeutic Goods Administration (TGA) 
• Coordinating Office For Clinical Trial Research 
• Ethical Considerations in Quality Assurance and Evaluation Activities 

Further Reading 

• Declaration of Helsinki 2013
• Vic Health Records Act 2001 - Privacy Principles
• Statutory Guidelines on Research- Health Records Act 2001 (VIC)
• Victorian Privacy and Data Protection Act and associated Information Privacy Principles 
• NHMRC Guidelines under Section 95 Privacy Act - conduct of medical research 
• NHMRC Guidelines under Section 95A Privacy Act - conduct of medical research 
• Medical Treatment Planning and Decisions Act VIC 2016 
• Office of the Public Advocate: Medical Research Procedures Flowchart and Section 81 Certificate for Medical Research Procedures without consent 
• The Australian clinical trial handbook 
• Victorian Managed Insurance Authority (VMIA) Clinical Trials Guide 
• NHMRC Safety Monitoring and Reporting in Clinical Trials  
• NHMRC Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods