eSource

1. lut 28, 2025

What Does the 'eSource’ Mean?

eSource refers to the electronic capture of clinical trial data directly from the point of care. It involves using digital systems to record and store patient information, eliminating the need for paper-based source documents and subsequent transcription into electronic data capture systems.

This approach aims to improve data quality, reduce errors, and streamline the clinical research process. eSource can include various digital data collection methods, such as electronic health records (EHRs), wearable devices, and patient-reported outcome measures (PROMs) captured through mobile applications or web-based platforms.

Why Is the 'eSource’ Important in Clinical Research?

eSource is crucial in clinical research as it significantly enhances data integrity and efficiency. By eliminating manual transcription steps, it reduces the potential for human error and allows for real-time data collection, leading to more accurate and timely insights.

Furthermore, eSource facilitates compliance with regulatory requirements and streamlines the audit process. It provides a clear electronic trail of data collection, making it easier for sponsors and regulatory bodies to verify the authenticity and quality of clinical trial data, ultimately accelerating the drug development process.

Good Practices and Procedures

1. Implement standardized data collection templates across all study sites to ensure consistency and facilitate seamless integration with central databases.
2. Establish robust data validation rules within eSource systems to flag potential errors or inconsistencies in real-time, enabling immediate correction.
3. Conduct regular system audits and implement version control mechanisms to maintain data integrity and traceability throughout the study lifecycle.
4. Develop comprehensive training programs for site staff on eSource technologies, emphasizing data privacy, security protocols, and proper documentation practices.
5. Implement automated data synchronization and backup procedures to prevent data loss and ensure accessibility across multiple platforms and devices.

Related Terms

• Training Compliance
• Primary Endpoint
• Device Master Record