Data Collection & CRF Management Flashcards

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

Answer: Convert to grams and document the conversion method used

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

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

Answer: They allow auditors to verify CRF entries against original records

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

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:

Answer: A protocol deviation requiring documentation and notification

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

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

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

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

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

Answer: Transcribe responses directly into the EDC system during the call

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

A CRF asks for the 'primary reason for early breastfeeding cessation.' If a mother gives two equally weighted reasons, the educator should:

Answer: Follow protocol instructions on handling multiple responses, or query the sponsor

Protocol or sponsor guidance must be followed when ambiguous situations arise; if guidance is absent, a query should be raised.

Calibration records for infant scales used in a lactation study should be stored:

Answer: As part of the study's essential documents at the site

Calibration records are essential documents that must be maintained at the study site to demonstrate data quality and equipment reliability.