CCDM Clinical Data Collection & Management 4

Question 1

Which ICH E6(R2) guideline principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?

Accepted Answer

ALCOA principle

Answer

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?

Accepted Answer

Contact the site to verify enrollment numbers against the randomization list and protocol eligibility

Answer

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?

Accepted Answer

AE (Adverse Events)

Answer

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?

Accepted Answer

Data validation applies programmatic checks to detect errors; data cleaning resolves those errors through queries and corrections

Answer

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?

Accepted Answer

The sample collection time and sample processing/centrifugation time

Answer

Recording both collection time and processing time allows the data manager to calculate elapsed time and verify the two-hour protocol requirement was met.

(CCDM) Certified Clinical Data Manager Practice Test

(CCDM) Certified Clinical Data Manager Practice Test

CCDM Clinical Data Collection & Management 4