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. Which data element on a CRF would be considered 'objective' rather than 'subjective'?

    Answer: Infant weight measured on a calibrated digital scale

    Objective data are measured by instruments or direct observation rather than reported by the subject, making scale-measured weight objective.

  2. When entering a correction in an electronic data capture (EDC) system, which element is automatically captured to meet audit trail requirements?

    Answer: The date, time, and user ID associated with each change

    EDC audit trails automatically capture the timestamp and user ID for every data change, fulfilling 21 CFR Part 11 requirements.

  3. A lactation registry collects ZIP code as a proxy for socioeconomic status. This approach is best described as using:

    Answer: A surrogate variable

    ZIP code is a surrogate (proxy) variable used to approximate a construct — socioeconomic status — that is difficult to measure directly.

  4. Which practice violates data integrity principles when completing a paper CRF?

    Answer: Using correction fluid to cover and overwrite an incorrect entry

    Correction fluid (whiteout) is prohibited because it obscures the original entry, destroying the audit trail.

  5. A study collects data on the number of wet diapers per day as a proxy for adequate infant hydration. This variable is measured on which scale?

    Answer: Ratio

    Diaper counts are ratio data because they have a true zero (zero diapers is possible) and equal intervals between values.

  6. A lactation educator conducting a hospital quality improvement project does NOT need IRB approval primarily because:

    Answer: The intent is to improve local practice, not to generate generalizable knowledge

    QI projects are typically exempt from IRB review when the primary intent is improving local processes rather than producing generalizable research.

  7. A CRF field for 'date of first breastfeed' is left blank because the mother cannot recall. The educator should:

    Answer: Document 'UNK' or 'unknown' per protocol conventions

    Protocol-defined codes such as 'UNK' or 'unknown' preserve data transparency when exact dates cannot be verified.