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Data Management Flashcards

6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 6 Data Management flashcards as text

  1. What is the purpose of a Data Safety Monitoring Board (DSMB)?

    Answer: To independently review accumulating trial data to protect subject safety and trial integrity

    A DSMB is an independent committee that periodically reviews accumulating data to assess safety, efficacy, and trial conduct, with authority to recommend stopping the trial.

  2. In the context of CDISC standards, what does CDASH stand for?

    Answer: Clinical Data Acquisition Standards Harmonization

    CDASH (Clinical Data Acquisition Standards Harmonization) provides standards for collecting clinical trial data in CRFs to enable consistent data capture.

  3. What is database lock in a clinical trial?

    Answer: The process of finalizing the clinical database after all data issues are resolved, preventing further changes

    Database lock is the final step in data management where all queries are resolved and the database is locked against further changes before statistical analysis.

  4. What does 'data validation' mean in clinical trial management?

    Answer: Checking data for completeness, consistency, and accuracy against predefined rules

    Data validation in clinical trials involves programmatic or manual checks to identify data errors, inconsistencies, or missing values against validation rules.

  5. Under GCP, which of the following best describes a 'certified copy'?

    Answer: A verified copy that has the same information as the original and is confirmed by a dated signature

    A certified copy is a copy verified to have the same information as the original, confirmed as such by a dated signature, and is acceptable in place of the original.

  6. What is 'blinded data review' in clinical research?

    Answer: Reviewing and cleaning data before treatment allocation codes are revealed

    Blinded data review involves reviewing and resolving data issues before breaking the randomization code to prevent bias in data cleaning decisions.