The Evolution of Clinical Data Management

Clinical data management has changed substantially over the past several decades. In earlier research settings, many studies relied on paper-based case report forms, handwritten clinic notes, laboratory registers, paper consent logs, manual filing systems, and physical archives. Data clerks transcribed information from paper forms into spreadsheets or database systems, and data managers performed manual checks to identify missing values, transcription errors, implausible measurements, and inconsistencies between forms. This approach could work for small studies, but it was slow, error-prone, and difficult to scale.