Austin Health requires that all principal investigators, associate investigators and clinical trial coordinators on any research project hold current TransCelerate accredited good clinical practice (GCP) certification.
A copy of the course completion certificate should be included with the research governance application.
Investigators who do not hold current GCP certification should email the Office for Research to arrange to undertake online GCP training.
Austin Health has adopted the minimum standards defined by TransCelerate Biopharma Inc. to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations. Acceptable GCP training courses are those listed on TransCelerate Biopharma Inc.
The principles of GCP have their origin in the World Medical Association’s Declaration of Helsinki. The Declaration of Helsinki was responsive to the revelations of the Nuremberg trials conducted after World War II, and its drafters sought to ensure that human subjects involved in clinical research would, in future, have their rights, safety and well-being placed above all other considerations in clinical research. The document has been revised several times since it was first published in 1964.
The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the “Good Clinical Practice” (GCP) guidelines, even though the guidelines apply to clinical research rather than clinical practice. The GCP guideline details the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.
The Therapeutic Goods Administration (TGA) has adopted the European Union version of these guidelines in Australia. The TGA advice includes specific comments from the TGA relevant to the Australian context.
Do you need funding for a research project?
Do you want to know what practical strategies increase your chances of success?
Come along and hear from an expert, Dr Noel Chambers, CEO of National Foundation for Medical Research and Innovation
Thursday 19 April 2018
Austin Doyle Lecture Theatre
Level 4, Austin Tower,
Everyone welcome. No need to register.
Brought to you by the Fundraising Department and Office for Research.
Are you a researcher with a keen interest in clinical trials? Are you keen to embark on your own research study, or to learn more about clinical trials but are not sure how to get started?
The Victorian Comprehensive Cancer Centre will host a FREE one-day workshop on Friday April 27, 2018 at Austin Health to introduce researchers to clinical trials, taking them on a journey along the clinical trials pathway from developing a research question through to getting a study started.
Emerging researchers with a keen interest in clinical trial design or those wanting to embark on their own research study.
Registration is essential and spaces are limited.
Register via Eventbrite: VCCC Clinical Trials Workshop, 27 April: Understanding the Research Pipeline
The Victorian Comprehensive Cancer Centre is an alliance of 10 major hospitals (including Austin Health), research institutes and the University of Melbourne, working together to control and cure cancer. The VCCC facilitates and enables genuinely collaborative, multi-partner, cross-disciplinary research and programs that advance cancer knowledge, treatments and patient outcomes.