Electronic Data Capture
Electronic Data Capture (EDC) is a software system used in clinical research to collect, manage, and validate data from clinical trials in electronic format. It replaces paper-based case report forms (CRFs) with digital forms, enabling real-time data entry, automated validation checks, and streamlined data management. EDC systems are essential for ensuring data quality, regulatory compliance, and efficient trial execution in pharmaceutical, biotechnology, and medical device research.
Developers should learn EDC when working in healthcare technology, clinical research organizations (CROs), or pharmaceutical companies to build or maintain systems for clinical trials. It's crucial for roles involving data collection software, regulatory compliance (e.g., FDA 21 CFR Part 11), and integration with other clinical systems like electronic health records (EHRs) or clinical trial management systems (CTMS). Use cases include designing data entry interfaces, implementing validation rules, and ensuring data security and audit trails for regulatory submissions.