The contribution of Information Technology: Towards a better clinical data management

Clinical data management is a vital vehicle in medical research to ensure the integrity and quality of data used to take medical decisions. When applied to clinical trials or observational studies it must comply with several regulations and guidelines developed in recent years; these include general purpose national and international legislation for data privacy and data protection, good clinical practice (GCPs) for medical interventions, and specific guidelines for electronic data submission to regulatory agencies. The aim of this article is to briefly illustrate the above-mentioned guidelines and legislation from the data-acquisition perspective and to describe how this process can be improved through a proper and prudent application of current information technology. Furthermore, a practical application using the current state of the art and, in particular, the web-based technology, will be presented with two real case studies.