Certified Lactation Specialist Data Collection & CRF Management 2 — Questions and Answers
Question 1: When a data entry error is discovered in a paper CRF, what is the correct procedure?
- Erase the error and write the correct value
- Use correction fluid (white-out) to cover the error
- Draw a single line through the error, write the correct value, and initial and date the change (Correct answer)
- Discard the page and complete a new CRF
Correct answer: Draw a single line through the error, write the correct value, and initial and date the change
The standard for correcting CRF errors is to cross out with a single line, preserving readability, then add the correct value along with initials and date.
Question 2: Which type of data is BEST captured using a Likert scale in a lactation research CRF?
- Infant birth weight
- Number of wet diapers per day
- Maternal perception of milk supply adequacy (Correct answer)
- Duration of exclusive breastfeeding in weeks
Correct answer: Maternal perception of milk supply adequacy
Likert scales measure subjective perceptions and attitudes, making them ideal for capturing a mother's perception of milk supply.
Question 3: In a lactation clinical trial, 'source data' refers to which of the following?
- Data entered into the electronic database
- The original records from which CRF data are transcribed (Correct answer)
- Sponsor-reviewed final datasets
- De-identified summary reports
Correct answer: The original records from which CRF data are transcribed
Source data are the original documents (e.g., medical records, feeding logs) that serve as the basis for CRF entries.
Question 4: A lactation consultant is collecting data on breastfeeding frequency. What is the most appropriate interval for recall accuracy?
- Previous 7 days
- Previous 30 days
- Previous 24 hours (Correct answer)
- Previous 48 hours
Correct answer: Previous 24 hours
A 24-hour recall period minimizes memory bias and is considered the standard for feeding frequency data in infants.
Question 5: Which of the following best describes a query in electronic data capture (EDC) systems?
- A summary report of all collected data
- A flag generated when data appears inconsistent or missing, requiring clarification (Correct answer)
- A type of CRF used for adverse event reporting
- An automated reminder to enroll new participants
Correct answer: A flag generated when data appears inconsistent or missing, requiring clarification
Queries are discrepancy flags in EDC systems that alert site staff to missing or inconsistent data entries requiring resolution.
Question 6: When is it appropriate to leave a CRF field blank in a lactation study?
- When the data point is not applicable to a particular participant (Correct answer)
- Whenever the participant declines to answer
- To speed up data entry
- When the answer is zero
Correct answer: When the data point is not applicable to a particular participant
CRF fields should only be left blank when the question is genuinely not applicable; otherwise, a specific notation such as 'ND' (not done) or '0' should be recorded.
Question 7: Which principle of good clinical data management ensures that data can be attributed to its originator?
- Legibility
- Contemporaneity
- Attributability (Correct answer)
- Completeness
Correct answer: Attributability
Attributability means data can be traced back to the individual who collected or entered it, typically ensured by signatures, initials, or electronic audit trails.
Certified Lactation Specialist Data Collection & CRF Management 2
When a data entry error is discovered in a paper CRF, what is the correct procedure?