CCDM Clinical Data Collection & Management 4 — Questions and Answers
Question 1: Which ICH E6(R2) guideline principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?
- CDISC SDTM principle
- ALCOA principle (Correct answer)
- GCP audit trail standard
- FDA 21 CFR 312 requirement
Correct answer: ALCOA principle
The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) is the foundational data quality standard embedded in ICH E6(R2) GCP guidelines.
Question 2: 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?
- Import all 200 additional records without further investigation
- Contact the site to verify enrollment numbers against the randomization list and protocol eligibility (Correct answer)
- Delete the extra records and proceed with expected count
- Immediately notify the FDA of a potential GCP violation
Correct 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.
Question 3: In CDISC SDTM, which domain is used to capture adverse events?
- CM (Concomitant Medications)
- AE (Adverse Events) (Correct answer)
- MH (Medical History)
- DS (Disposition)
Correct answer: AE (Adverse Events)
The AE domain in CDISC SDTM is specifically designated to capture all adverse event data collected during a clinical trial.
Question 4: What is the difference between 'data cleaning' and 'data validation' in clinical data management?
- They are the same process performed at different stages of the trial
- Data validation applies programmatic checks to detect errors; data cleaning resolves those errors through queries and corrections (Correct answer)
- Data cleaning occurs before data entry; data validation occurs after database lock
- Data validation is performed only by biostatisticians; data cleaning is performed only by data managers
Correct 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.
Question 5: 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?
- The laboratory reference range for the analyte
- The sample collection time and sample processing/centrifugation time (Correct answer)
- The investigator's signature on the lab requisition form
- The shipment tracking number for the sample
Correct 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.
Question 6: When a subject withdraws consent and requests data deletion, what is the data manager's obligation under GCP?
- Immediately delete all subject data from the trial database
- Retain data collected up to the withdrawal date, as retrospective deletion of already-collected data is generally not required under GCP (Correct answer)
- Transfer all subject data to the IRB for storage
- Suspend database access for all trial staff until legal review is complete
Correct 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.
Question 7: Which of the following best describes 'risk-based monitoring' (RBM) as it applies to data management?
- Monitoring all data fields at every site with equal frequency regardless of importance
- Focusing oversight resources on the highest-risk data, sites, and processes based on predefined risk indicators (Correct answer)
- Eliminating on-site monitoring visits in favor of centralized statistical review only
- Requiring every CRF field to undergo 100% source data verification
Correct 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.
CCDM Clinical Data Collection & Management 4
Which ICH E6(R2) guideline principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?