Data Entry Processes in Clinical Research

This technical report outlines the established procedures necessary for data receipt and entry in clinical research to ensure the production of a high-quality clinical database. It discusses the importance of reducing errors during data entry processes and maintaining consistency in the database. Key topics include workflow components, data receipt and tracking, data entry, data review, data cleaning, and change control for case report forms and databases. The report emphasizes the significance of quality control at each stage of data handling, as per the International Conference on Harmonisation’s Guidance for Industry: E6 Good Clinical Practice. It details the roles of personnel involved in data management and the need for appropriate training and access levels. Additionally, it presents best practices for data entry, including methodologies like double data entry and the importance of comprehensive user training. The report also highlights the workflow of data entry processes, addressing both electronic and paper-based systems.