Data Collection and EDC Systems Flashcards

What is a 'blind data review' (BDR) in clinical data management?

Answer: A review of cleaned, blinded data by the study team before unblinding to confirm readiness for analysis

A BDR is a pre-lock review conducted while the treatment assignments remain blinded, allowing the team to finalize data cleaning decisions, confirm analysis populations, and document conventions.

What is the role of a 'data transfer specification' in EDC implementations involving external data feeds?

Answer: To define the format, structure, frequency, and validation rules for data imported from external sources such as labs

A data transfer specification documents the exact file format, field definitions, timing, and acceptance criteria for external data feeds (e.g., central lab or ePRO) integrated into the EDC.

In the context of EDC systems, what is 'role-based access control'?

Answer: A security mechanism that grants users access only to data and functions permitted by their assigned role

Role-based access control assigns permissions based on job function, ensuring that site coordinators, monitors, data managers, and biostatisticians each access only the data and tools appropriate to their role.

What is a 'screen failure' in clinical trial data collection?

Answer: A subject who consents and undergoes screening assessments but does not meet eligibility criteria to enroll

A screen failure occurs when a subject who signed informed consent and underwent screening assessments is found ineligible for enrollment based on inclusion/exclusion criteria.

What is the purpose of a 'data listing review' prior to database lock?

Answer: To manually review tabular data listings to identify any remaining errors or inconsistencies before locking the database

A data listing review involves manual examination of data listings by the data management team and sometimes clinical staff to catch residual errors not flagged by automated edit checks.

In EDC data management, what is the significance of a 'query aging report'?

Answer: It tracks how long outstanding queries have been open, helping management identify and escalate unresolved issues

A query aging report shows the duration that each open query has been outstanding, helping data managers prioritize follow-up with sites and ensure timely resolution before database lock.