Clinical data management A Review of Current Practice in Australia

Abstract

The practice of clinical data management (CDM) in Australia has seen and continues to experience tremendous growth. As such, this article reviews the current practice of CDM in Australia. The article addresses the history of the profession and provides insight into the difference between the sectors, the evolving role, ongoing requirements for training and education, and an overview of the regulations and how these impact the Australian CDM landscape. Current practice of CDM in Australia differs considerably between industry, academic, and non-profit sectors though the uniform regulatory requirements are provided nationwide. This has raised challenges for mostly academic, non-profit, and small-scale trials which are more likely to lack access to resources, facilities, management, and funding. Australian clinical data managers are required to have formal skills related to data, technology, security, and project management, though they are also expected to operate at the highest levels of excellence across all areas of their diverse roles. It is only in recent years that CDM has evolved to a stronger focus on data quality. Regardless of these challenges, clinical data managers have played, and continue to play, a key role in Australian biomedical research. They have provided guidance on data collection, processing, and management procedures to ensure that studies achieve high quality outcomes. However, more research is needed to develop specific CDM training courses to help Australian clinical data managers to meet a standard of knowledge, education, and experience to be officially recognised as a profession.