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.
Plain English is a style of writing that enables you to get your message across more often, more easily and in a clear way. It is written with everyone in mind. These sessions would be beneficial for Researchers for writing of lay summaries in research consent forms, patient brochures, informations sheets and project invitation letters. For further information on how to book your place in one of these sessions, please contact the Office for Research.
Plain Language Theory- Part 1
Learn some of the basics of health literacy, plain English and managing consumer brochures at Austin Health at this session.
Plain Language Workshop -Part 2
Book a time to work on your brochure or web page with a plain English lead. Attending the plain English Theory session or having an understanding of the plain English tips is expected prior to making this booking.