Data Collection & CRF Management Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Data Collection & CRF Management flashcards as text
Which regulatory guidance document provides the foundational requirements for electronic records and electronic signatures in US clinical trials?
Answer: 21 CFR Part 11 Electronic Records; Electronic Signatures
21 CFR Part 11 (Electronic Records; Electronic Signatures) is the US regulatory framework governing the use of electronic systems for records and signatures in FDA-regulated studies.
A CTA is responsible for reviewing open queries before a data lock. What is the correct priority for resolving a query marked 'critical'?
Answer: Resolve it immediately, as critical queries affect primary endpoint data or subject safety decisions
Critical queries typically involve primary efficacy endpoints, safety data, or eligibility criteria — they must be resolved before database lock and take priority over routine data cleaning.
The term 'database lock' in clinical trial data management refers to:
Answer: Freezing the clinical database after all data cleaning is complete so no further changes can be made before analysis
Database lock is the formal process of declaring all data clean and complete, then restricting further edits so that statistical analysis proceeds on a final, verified dataset.
A site coordinator mistakenly enters data from Subject 105 into Subject 106's CRF in an eCRF system. What is the most appropriate course of action?
Answer: Contact the data management team immediately, document the error, correct both subject records with full audit trail entries and explanations
Data mix-ups between subjects require immediate notification of the data management team, transparent correction in both records, and full audit trail documentation to ensure data integrity.
ICH E6(R2) guidance on source data states that source data should be:
Answer: Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available (ALCOA+)
ICH E6(R2) expanded the ALCOA principles to ALCOA+ by adding Complete, Consistent, Enduring, and Available to further define good data and records management in clinical trials.
A sponsor conducting a Phase II trial decides to implement a 'risk-based approach to source data verification' (SDV). This means:
Answer: SDV is prioritized on critical data fields (e.g., primary endpoints, eligibility, safety) rather than all data equally
Risk-based SDV focuses monitoring resources on data that is critical to trial conclusions or subject safety rather than applying uniform 100% verification to all data fields.
When a clinical site undergoes an FDA inspection, which of the following CRF-related items would an investigator MOST likely be asked to produce?
Answer: Original source documents for enrolled subjects along with the corresponding CRF pages and any query resolution documentation
FDA inspectors review original source records alongside CRF entries and query documentation to verify data accuracy, completeness, and compliance with GCP — this is the core of an inspection.