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. When collecting data on exclusive breastfeeding duration, which denominator is most appropriate for calculating prevalence at six months?

    Answer: All infants who reached six months of age in the cohort

    Prevalence at six months should use all infants who survived to six months as the denominator to avoid selection bias.

  2. A CRF query asks the lactation educator to clarify whether a reported feeding was 'breast' or 'expressed breast milk.' The best response is to:

    Answer: Review the source document and respond with the verified information

    CRF queries must be resolved by reviewing the original source document and providing verified, accurate information.

  3. Which scale of measurement is used when recording a mother's breastfeeding intention as 'plans to breastfeed' vs. 'does not plan to breastfeed'?

    Answer: Nominal

    Categories without an inherent rank order or numerical value are nominal (categorical) data.

  4. An educator discovers that 15 CRF entries from a previous month were never signed. The FIRST corrective step is to:

    Answer: Notify the study coordinator and follow the site's data correction SOP

    Unsigned CRFs are a protocol deviation that must be escalated to the coordinator and corrected per the site's SOP; back-dating or destroying records is fraud.

  5. In a breastfeeding support program database, a unique subject identifier (ID) primarily serves to:

    Answer: Link subject records across visits while protecting PHI

    A unique subject ID links longitudinal records while replacing personally identifiable information to protect subject privacy.

  6. During a monitor visit, the clinical research associate (CRA) requests access to a mother's complete medical chart to verify CRF data. The lactation educator should:

    Answer: Facilitate access to relevant records per the signed informed consent and authorization

    Signed informed consent and HIPAA authorization typically permit sponsor monitors to review source documents necessary for verification.

  7. A lactation educator wants to compare average milk volume expressed by mothers at weeks 2, 4, and 6 postpartum. The most appropriate statistical test is:

    Answer: Repeated measures ANOVA

    Repeated measures ANOVA is designed to compare means across three or more time points within the same subjects.