Converting from Paper-Based to Electronic Data Capture and Record Keeping in Clinical Trial Management: Benefits, Challenges and Practical Considerations

Clinical research has lagged behind the technological advance of other healthcare fields. Most investigational sites depend on a paper‐based data capture and record retention system. This practicum project examined the various benefits and challenges of electronic data capture and electronic record keeping systems. Electronic systems can improve data integrity, reduce trial cost and increase efficiency in the course of a clinical trial. However, electronic systems can also pose some challenges, including implementation and training cost, decreased productivity, and issues with data security and health record privacy. This project discussed some practical considerations for investigational sites transitioning to electronic systems. These aims were accomplished by review of the literature and consulting investigational sites through an email questionnaire.