CLE Data Collection & CRF Management 2 — Questions and Answers
Question 1: When a mother reports infant weight in pounds and ounces but the CRF requires metric units, the educator should:
- Record the stated pounds/ounces and note the discrepancy
- Convert to grams and document the conversion method used (Correct answer)
- Leave the field blank until the scale is recalibrated
- Ask the physician to re-weigh the infant before documenting
Correct 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.
Question 2: Which principle best describes why source documents must be retained even after CRF data is finalized?
- Source documents serve as legal proof of the educator's licensure
- They allow auditors to verify CRF entries against original records (Correct answer)
- Retention is only required for pediatric subjects under age two
- They are used to calculate educator compensation
Correct 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.
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:
- Acceptable if the colleague reviewed the video recording
- A protocol deviation requiring documentation and notification (Correct answer)
- Standard practice when staff coverage changes occur
- Permissible as long as both names appear on the form
Correct 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.
Question 4: In longitudinal breastfeeding studies, 'missing at random' (MAR) data means:
- Data are missing due to equipment failure unrelated to the outcome
- The probability of missingness depends on unobserved values
- Missingness is related to observed variables but not the missing value itself (Correct answer)
- All missing data points were deliberately excluded by the investigator
Correct 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.
Question 5: Which of the following is the MOST appropriate method to document a phone-based infant feeding history collected by a lactation educator?
- Transcribe responses directly into the EDC system during the call (Correct answer)
- Record notes on scratch paper, then enter data within 30 days
- Have the mother email her answers before any CRF entry is made
- Estimate answers based on prior visit data if the call is brief
Correct 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.
Question 6: A CRF asks for the 'primary reason for early breastfeeding cessation.' If a mother gives two equally weighted reasons, the educator should:
- Select the reason that appears first on the drop-down list
- Choose the reason with the strongest clinical evidence
- Follow protocol instructions on handling multiple responses, or query the sponsor (Correct answer)
- Document only the physiological reason and omit the psychosocial one
Correct 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.
Question 7: Calibration records for infant scales used in a lactation study should be stored:
- Only in the educator's personal files for confidentiality
- As part of the study's essential documents at the site (Correct answer)
- Discarded after each calibration to reduce paper clutter
- Sent exclusively to the IRB for independent verification
Correct 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.
CLE Data Collection & CRF Management 2
When a mother reports infant weight in pounds and ounces but the CRF requires metric units, the educator should: