ABSTRACT

Clinical trials data are an essential asset for any pharmaceutical company, one of the few assets that truly increases in value over time. This data must therefore be valued and managed as an asset. For this reason, clinical data management is not something a data entry clerk or a data manager does. Rather, this critical function is performed by professional data managers. Their skill set does not revolve around creating tables in a database, but in identifying, describing, and acquiring (with clinical research colleagues) the data that makes up a regulatory submission. Clinical data management is about bringing quality to data. It is the practice of identifying problem data, verifying the source of the data, and facilitating the process of continual data improvement. It ensures that the collection of clinical trial data is continually improving the methodology, phases, and activities of a clinical trial.