Clinical Data Collection & Management Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Clinical Data Collection & Management flashcards as text
Which ICH E6(R2) guideline principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?
Answer: ALCOA principle
The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) is the foundational data quality standard embedded in ICH E6(R2) GCP guidelines.
A data manager receives an interim dataset from a clinical site that includes 200 more subject records than expected. What is the most appropriate first step?
Answer: Contact the site to verify enrollment numbers against the randomization list and protocol eligibility
Before taking any action, the data manager must confirm whether the extra records represent legitimate enrollments, data duplication, or an error by cross-referencing the randomization list.
In CDISC SDTM, which domain is used to capture adverse events?
Answer: AE (Adverse Events)
The AE domain in CDISC SDTM is specifically designated to capture all adverse event data collected during a clinical trial.
What is the difference between 'data cleaning' and 'data validation' in clinical data management?
Answer: Data validation applies programmatic checks to detect errors; data cleaning resolves those errors through queries and corrections
Validation uses automated edit checks to flag potential errors, while cleaning is the follow-up process of resolving those flags through site queries and verified corrections.
A protocol specifies that laboratory samples must be processed within two hours of collection. Which data point is most important to capture to verify compliance?
Answer: The sample collection time and sample processing/centrifugation time
Recording both collection time and processing time allows the data manager to calculate elapsed time and verify the two-hour protocol requirement was met.
When a subject withdraws consent and requests data deletion, what is the data manager's obligation under GCP?
Answer: Retain data collected up to the withdrawal date, as retrospective deletion of already-collected data is generally not required under GCP
GCP requires retention of data already collected before withdrawal, as deleting historical data would undermine the integrity of the trial record; withdrawal prevents future collection only.
Which of the following best describes 'risk-based monitoring' (RBM) as it applies to data management?
Answer: Focusing oversight resources on the highest-risk data, sites, and processes based on predefined risk indicators
RBM directs monitoring effort toward areas of greatest risk to subject safety and data integrity, using centralized analytics and targeted on-site visits rather than universal 100% SDV.