CLE Data Collection & CRF Management 2

Question 1

When a mother reports infant weight in pounds and ounces but the CRF requires metric units, the educator should:

Accepted Answer

Convert to grams and document the conversion method used

Answer

Converting to the required metric unit and documenting the conversion method maintains data integrity and CRF compliance.

Question 2

Which principle best describes why source documents must be retained even after CRF data is finalized?

Accepted Answer

They allow auditors to verify CRF entries against original records

Answer

Retaining source documents allows auditors and monitors to verify that CRF data accurately reflects original observations.

Question 3

A lactation educator notes that a CRF entry for latch assessment was made by a colleague who did not observe the feeding. This is best described as:

Accepted Answer

A protocol deviation requiring documentation and notification

Answer

Data entries must be made by the person who directly observed or performed the assessment; any deviation must be documented and reported.

Question 4

In longitudinal breastfeeding studies, 'missing at random' (MAR) data means:

Accepted Answer

Missingness is related to observed variables but not the missing value itself

Answer

MAR means the likelihood of data being missing depends on other observed variables, not on the value of the missing data itself.

Question 5

Which of the following is the MOST appropriate method to document a phone-based infant feeding history collected by a lactation educator?

Accepted Answer

Transcribe responses directly into the EDC system during the call

Answer

Entering data directly into the EDC system during the call creates a contemporaneous record and reduces transcription error.

(CLE) Certified Lactation Educator Practice Test