Useful resources; Training; Forms

Provided below are links to useful reference documents for all researchers submitting an application for ethical or governance review.

Also provided are the Peter MacCallum Cancer Centre Ethics Secretariat standard operating procedures, guidelines and the required forms.

In addition information is provided on available training.

USEFUL RESOURCES

The Basics

Further Reading

TRAINING

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.

FORMS

Retrospective Study Application Form

Low and Negligible Risk HREC Application Form- [select New Project, select Victoria, then select LNR VIC (Victoria only)]

Human Research Ethics Application (HREA)

Victorian Specific Module

Site Specific Assessment (SSA) Application

Declaration by Head of Supporting Department Form

Participant Information and Consent Form- Templates for different types of research/consent situations can be found under sections 5 and 8 

Amendment Request Form

Progress report- Project Form (HREC)

Progress report- Site Form (RGO)

Project final report / Site closure report

Safety Report

Annual Safety Report Form

Protocol Deviation or Violation Report

Complaint Report

STANDARD OPERATING PROCEDURES AND GUIDELINES

SOP001- Ethics Committee

SOP002- Ethical Review Administration

SOP003- Handling Conflict of Interest in Ethical Review of Research

SOP004 Monitoring Ongoing Research

SOP005- Referral of Patients to External Research

SOP006- Safety Reporting

SOP007- Handling Clinical Research Project Participant and Prospective Participant Queries/Complaints

GUIDELINE001 Peter Mac Governance Review Requirements for Human Research

GUIDELINE002- Ethical Review Pathways and Submission Requirements

GUIDELINE003- Low and Negligible Risk Research Ethical Review

GUIDELINE004- Divisional Review