EDC & CDMS Systems Flashcards

In an EDC system, what is the primary purpose of a 'skip pattern' (conditional branching)?

Answer: To automatically navigate users past questions that are not applicable based on prior responses

Skip patterns use conditional logic to hide or bypass fields/pages that are not relevant given earlier data entries, reducing site burden and data entry errors.

Which regulatory document specifically addresses the use of electronic records and electronic signatures in clinical trials conducted in the US?

Answer: FDA 21 CFR Part 11

FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records.

A site coordinator accidentally enters a wrong date for a subject's visit. After correcting it in the EDC, what must be preserved?

Answer: Both the original entry and the correction, with reason and timestamp, in the audit trail

EDC audit trails must capture the original value, the corrected value, the date/time of change, and the user who made the change, ensuring data integrity.

What does 'edit check' mean in the context of an EDC system?

Answer: An automated validation rule that flags inconsistent or out-of-range data entries in real time

Edit checks are programmed rules within the EDC that trigger immediate alerts when entered data violates predefined logical or range constraints.

In CDMS terminology, what is a 'discrepancy' (also called a query)?

Answer: A flag raised when data does not meet validation rules or appears inconsistent, requiring site clarification

A discrepancy or query is a question raised to the site when data entries are missing, inconsistent, or out of range, prompting the site to clarify or correct.

Which of the following best describes 'database lock' in a clinical trial?

Answer: The formal process of freezing the clinical database after all data have been cleaned and verified, preventing further edits

Database lock is a controlled milestone at which all data cleaning is complete, the database is declared final, and no further changes are permitted prior to analysis.

What is the main advantage of real-time data entry in an EDC system compared to paper-based CRFs?

Answer: It allows sponsors and monitors to review and query data almost immediately after entry, accelerating data cleaning

Real-time EDC entry enables near-immediate visibility of data to monitors and data managers, allowing queries to be raised and resolved faster than with paper CRF transcription.