Electronic Source (eSource) refers to the use of electronic systems to capture, store, and manage source data for clinical trials directly at the point of creation. eSource data includes any information captured electronically that serves as the original record of patient data, such as electronic health records (EHRs), laboratory results, and patient-reported outcomes.
Key Features of eSource Systems:
- Direct Data Capture: Collects data directly from electronic health records, diagnostic devices, and other electronic systems at the point of care.
- Interoperability: Integrates with various health information systems to facilitate seamless data exchange and aggregation.
- Data Integrity: Ensures data accuracy and completeness through automated validation checks and audit trails.
- Regulatory Compliance: Adheres to regulatory standards such as 21 CFR Part 11, ensuring the reliability and authenticity of electronic records.
Benefits of eSource Systems:
- Streamlined Data Collection: Reduces duplication of efforts by capturing data directly from electronic sources, eliminating the need for manual transcription.
- Enhanced Data Quality: Improves the accuracy and consistency of clinical trial data through real-time data capture and automated validation checks.
- Regulatory Acceptance: Increasingly supported by regulatory authorities, facilitating more efficient regulatory submissions and reviews.
- Cost Savings: Reduces costs associated with data entry, monitoring, and storage by leveraging existing electronic health records and other electronic systems.