Practice Test Geeks(CLE) Certified Lactation Educator Practice Test
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Data Collection & CRF Management Flashcards

7 cards from real CLE 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

  1. A CRF includes a field for 'type of supplemental feeding given in hospital.' Which data collection approach would yield the HIGHEST accuracy?

    Answer: Abstracting data from the nursing administration record during hospital stay

    Abstracting data contemporaneously from the nursing administration record provides the most accurate, timely documentation of supplemental feedings.

  2. In a breastfeeding cohort study, 'loss to follow-up' is a concern because it can introduce:

    Answer: Attrition bias

    Loss to follow-up leads to attrition bias if those who drop out differ systematically from those who remain.

  3. According to GCP, who bears ultimate responsibility for the accuracy and completeness of CRF data at a clinical site?

    Answer: The principal investigator at the site

    GCP E6(R2) places ultimate responsibility for data accuracy and completeness on the principal investigator.

  4. A lactation educator uses a validated tool to measure breastfeeding self-efficacy. The tool yields consistent scores when administered twice within 48 hours. This property is called:

    Answer: Test-retest reliability

    Test-retest reliability reflects a tool's ability to produce consistent scores across repeated administrations in a stable population.

  5. Which action best protects subject confidentiality when transmitting completed CRFs to a sponsor?

    Answer: Using a secure, password-protected EDC or encrypted file transfer

    Encrypted electronic transmission through a secure system prevents unauthorized access to sensitive subject data during transfer.

  6. A breastfeeding outcomes registry defines 'exclusive breastfeeding' differently than the WHO definition. When interpreting registry data, an educator should:

    Answer: Note the registry-specific definition when presenting or comparing findings

    Differences in operational definitions affect comparability; always disclose the definition used when reporting or comparing data.

  7. When a paper CRF page is damaged and partially illegible, the CORRECT response is to:

    Answer: Attach the damaged original and a legible photocopy with an explanatory note

    The original damaged document must be retained alongside a legible copy; both are kept with an explanation to preserve the audit trail.