Provided below are useful documents and information for all researchers submitting an application for ethical or governance review.
Forms: forms for new applications and post-approval submissions
Standard Operating Procedures and Guidelines: Peter Mac Ethics Committee and Human Research Ethics & Governance office procedures and guidelines
Useful Resources: external reference documents e.g. NHMRC National Statement on Ethical Conduct in Human Research
Training: information on required training (GCP) and available training
NEW APPLICATIONS
Human Research Ethics Application (HREA)
Victorian Specific Module [the VSM is also found as a sub-form in the HREA]
Western Australian Specific Module (WASM)
Clinical Trials Notification (CTN)
HREC Radiation Notification Letter
Site Specific Assessment (SSA) Application
POST APPROVAL
Declaration by Head of Supporting Department Form
Serious Breach Report Form (Sponsor)
Suspected Breach Report Form (Third Party)
Progress report- Project Form (HREC)
Progress report- Site Form (RGO)
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
Peter Mac 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), Co-Investigators (CIs) and other trial coordination staff undergo recognised Good Clinical Practice (GCP) training to conduct clinical trials.
The Peter MacCallum Cancer Centre Office of Cancer Research provides an accredited GCP training course in house that delivers tailored training that is acceptable to most clinical trial sponsors. For further information and bookings please email [email protected]
Peter Mac expects that:
- all current Principal Investigators on prospective interventional studies need to have successfully completed GCP training;
- all Principal Investigators and all staff on delegation logs will need to undertake accredited GCP training appropriate to their role and delegation; and
- researchers on all other human research projects are strongly encouraged to undertake GCP training.
As a rule, in addition to the Peter Mac GCP training course, Peter Mac will accept any single FDA/TGA accredited GCP training program as satisfying the mandated requirements. Records demonstrating attendance and successful completion of GCP training conducted outside Peter Mac or on-line should be provided to the Office of Cancer Research where a central registry of GCP staff is being maintained.
The recommended Peter Mac GCP training is valid for 3 years from the date of issue and it is expected that staff ensure that their training is always up-to-date. The Office of Cancer Research will send reminders to staff when refresher training falls due and will advertise GCP training dates to clinical research staff.
We expect that Investigators and Trial Coordinators also keep records of their GCP training (in the form of a copy of their training certificate) and that the date of the most recent update is recorded in their CV.
Ethics and Governance: If your department is interested in receiving training on submitting ethics and governance applications or on other ethics and governance topics please email [email protected] or call (03) 8559 7540 to discuss your requirements.
NHMRC: NHMRC provide training modules that provide an introduction to the clinical trials environment, clinical research ethics and ethical review and research governance processes.
