Data Collection and EDC Systems Flashcards

What is a 'query' in the context of EDC data management?

Answer: A request for clarification or correction of a data discrepancy identified in the EDC system

In EDC data management, a query is a formal request sent to site staff asking them to clarify, confirm, or correct a data discrepancy identified through edit checks or manual review.

What is the purpose of 'central data monitoring' in modern clinical trials?

Answer: To use statistical and analytical techniques to remotely evaluate data quality and site performance

Central data monitoring uses statistical tools to remotely evaluate data patterns, site performance, and potential issues, allowing risk-based targeting of on-site monitoring resources.

What is an 'unscheduled visit' in EDC data collection?

Answer: A visit that occurs outside the protocol-defined schedule, typically for safety reasons

An unscheduled visit is one not included in the protocol visit schedule, typically occurring for safety reasons such as adverse events, and must be documented in the EDC system.

What is the significance of 'data entry latency' in clinical EDC systems?

Answer: The time between a clinical event occurring and when data is entered into the EDC, which affects data quality and timeliness

Data entry latency measures how promptly data is entered after an event occurs; high latency risks data inaccuracy, query pile-up, and delayed issue detection.

In EDC design, what is a 'conditional field' (or dynamic field)?

Answer: A field that only becomes visible or required based on a response to a prior question

Conditional fields appear or become required based on logic tied to earlier responses, reducing irrelevant data entry and guiding site staff through form completion contextually.

What is 'discrepancy management' in clinical data management?

Answer: The systematic process of identifying, querying, resolving, and tracking data inconsistencies in the database

Discrepancy management encompasses all activities for detecting data issues through edit checks and manual review, generating queries, tracking resolutions, and verifying corrections.