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
The principles of GCP have their origin in the World Medical Association’s Declaration of Helsinki. The GCP guidelines detail 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.
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.
Tuesday 14 May 2019.
This foundational course is designed to build research capacity amongst clinicians for everyday practice. The program will guide participants through the basics of research design - developing a research question and protocol, tips for ethics, data collection and the art of survey writing, effective literature searching, statistics and critical appraisals. Participants will acquire the tools to form a firm foundation for any research undertaken in their area. The program will utilise open panel discussions, interactive presentations and expert speakers
Tuesday 20 August 2019.
This advanced course is designed to build capacity amongst clinicians interested in pursuing research beyond the basics. The program will guide participants through in-depth and advanced statistics for research, data management, qualitative research methodology, getting published as an author, how and where to present your research, and tips for grant applications