Winter 2005/06
Fundamentals of Clinical Data Management (abridged)
The mysteries of Clinical Data Management were unravelled during this one-day course hosted by the ACDM and held at the Novartis Foundation in London.
The course gave a comprehensive overview of Clinical Data Management activities and how these fit into the Clinical Trials' process. Fifteen delegates attended the course from a variety of backgrounds including global pharmaceutical companies and single centre Contract Research Organisations. Most delegates were recently appointed into Clinical Data Management posts or from Study Management backgrounds and wishing to extend their knowledge of Data Management. It was interesting to discuss how Data Management activities are managed in different settings.
The two trainers were lively, well informed and led a well balanced mix of interesting presentations providing an overview and insight into the major steps involved in the flow of Clinical Data from study set up to closure. Topics covered included CRF and database design, data entry, medical coding, data validation, data queries and quality control measures. There was plenty of time for discussion and theory was supported by anecdotes from the delegates and trainers own experience. Practical exercises were fun and relevant whilst a welcome prize of chocolates was appreciated!
This course is useful to anyone relatively new to Clinical Data Management, wishing to gain a broader understanding of Data Management activities and how these fit into the big picture of the Clinical Trials process.
Karina Meachin and Anna Robinson