Electronic Data Capture (EDC) Systems

Role of EDC Systems

During clinical trials, data quality and study efficiency are of the utmost importance. Electronic Data Capture (EDC) software helps sponsors collect trial data and manage processes including patient form design, medical coding, and source data verification. Prior to EDC, clinical trial data was documented on 3- part NCR paper, which was liable to various pain points. Data captured incorrectly at the source, forms delayed in transit, and inefficiency in back-and-forth communication were just a few challenges that sponsors faced. Nowadays, life sciences organizations typically capture data electronically at the source (“e-source”) or transcribe paper forms into an EDC system.

EDC User Roles

Sponsors, contract research organizations (CRO), and sites play critical roles in clinical data collection. Common EDC roles include:

• Study Builders
• System Administrators
• Data Managers
• Clinical Research Coordinates
• Clinical Research Administrations
• Study Investigators
• Medical Coding
• Inventory Control
• Biostatistics

A robust EDC platform supports them in the following day-to-day tasks

Sponsor/CRO

• Designing customized study forms (eCRF)
• Performing Validation and/or User Acceptance Testing, both at the system and study level
• Training sites on using the EDC for each specific study
• Overseeing studies to ensure compliance with protocols, Good Clinical Practices, and all applicable regulations
• Monitoring data collection for discrepancies
• Reviewing source documentation and case report forms
• Analyzing data metrics as requested by Sponsor
• Submitting queries to sites to resolve trial issues

Site

• Entering participant information, such as research data and patient’s background
• Reviewing and processing clinical trial data