Remote Data Entry (RDE) refers to entering clinical trial data into electronic systems from a location outside the traditional trial site environment.
RDE is commonly used in decentralized or hybrid trial models where data may be captured from home visits, telehealth encounters, or remote coordinators. Because data entry occurs off-site, RDE requires robust controls such as secure authentication, role-based permissions, and audit trails to maintain traceability. Clear SOPs define what can be entered remotely, how source documentation is maintained, and how discrepancies are resolved. Proper RDE governance improves flexibility while maintaining data integrity and inspection readiness.