ABSTRACT
Data from a clinical trial will be collected and stored in a computer system. The initial data capture method may be paper, a computer entry screen at the investigator’s site, a laboratory instrument, central lab system, or perhaps a handheld computer used to collect diary information from the subject. It is typically the clinical data manager who will specify (design) the structures to capture that data, though it may not always be the data manager who actually builds or programs the system. All data managers should understand the kinds of —elds and organization of —elds that affect storage, analysis, and processing of the trial data, and they should be aware of some of the options to weigh in making a design decision for those —elds.
