EDC (Electronic Data Capture) is a computerized system used in clinical trials and medical research to collect and manage patient information. It replaces traditional paper forms with digital ones, making it easier to gather, store, and analyze research data. Think of it as a specialized digital form system specifically designed for medical studies. Common EDC systems include Medidata Rave, Oracle Clinical, and REDCap. These systems help ensure data accuracy, speed up the research process, and make it easier for study teams to work together across different locations.
Managed patient data entry and quality control using EDC systems
Trained research coordinators on Electronic Data Capture protocols
Led implementation of EDC system across 5 clinical trial sites
Typical job title: "EDC Specialists"
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Q: How would you handle a multi-site clinical trial with different EDC training needs?
Expected Answer: Should discuss experience in creating training programs, coordinating across sites, ensuring consistent data entry standards, and managing different user access levels. Should mention strategies for ongoing support and monitoring.
Q: What steps would you take to ensure data quality in an EDC system?
Expected Answer: Should explain processes for data validation, quality checks, error prevention, monitoring procedures, and how to maintain data integrity throughout a clinical trial.
Q: How do you handle EDC system queries and data cleaning?
Expected Answer: Should explain the process of identifying data discrepancies, communicating with sites for clarification, and documenting resolution of queries while maintaining data integrity.
Q: Explain your experience with EDC system validation.
Expected Answer: Should describe understanding of system testing, documentation requirements, and ensuring the EDC system meets regulatory requirements and study protocols.
Q: What is the purpose of an EDC system in clinical trials?
Expected Answer: Should explain basic understanding of electronic data collection, its advantages over paper-based systems, and how it helps in managing clinical trial data.
Q: How do you ensure data entry accuracy in an EDC system?
Expected Answer: Should discuss basic data entry procedures, double-checking entries, following study protocols, and understanding the importance of accurate data collection.