Certified Lactation Specialist Data Collection & CRF Management 3 — Questions and Answers
Question 1: A mother in a lactation study reports she stopped breastfeeding between two scheduled visits. How should this be documented in the CRF?
- Leave the breastfeeding fields blank for that visit
- Record it as a protocol deviation and note the cessation date (Correct answer)
- Only document it at the next scheduled visit
- Remove the participant from the study immediately
Correct answer: Record it as a protocol deviation and note the cessation date
Any change in key study behaviors between visits should be captured as a protocol deviation with the relevant date to maintain data integrity.
Question 2: In a lactation support intervention study, what is the primary purpose of double data entry?
- To reduce transcription errors by comparing two independently entered datasets (Correct answer)
- To allow two different participants to complete the same CRF
- To speed up the data entry process
- To meet regulatory reporting timelines
Correct answer: To reduce transcription errors by comparing two independently entered datasets
Double data entry involves two separate individuals entering the same data, with discrepancies resolved to minimize transcription errors.
Question 3: Which of the following is an example of a continuous variable in a lactation CRF?
- Mode of delivery (vaginal vs. cesarean)
- Infant sex (male/female)
- Volume of expressed breast milk in milliliters (Correct answer)
- Maternal parity (nulliparous/multiparous)
Correct answer: Volume of expressed breast milk in milliliters
Volume of expressed milk is a continuous variable because it can take any value along a measurable scale.
Question 4: What does an audit trail in an electronic CRF system document?
- Final approved data only
- All data entries, modifications, deletions, and the user who made them with timestamps (Correct answer)
- Participant consent information exclusively
- Financial transactions related to the study
Correct answer: All data entries, modifications, deletions, and the user who made them with timestamps
Audit trails provide a chronological record of all changes to electronic data, ensuring accountability and supporting data integrity.
Question 5: A CRF asks for the date of the first postpartum lactation consultation. Which date format should be used per ICH E6 GCP guidelines?
- Month and year only (MM/YYYY)
- Day, month, year (DD/MMM/YYYY) (Correct answer)
- Numeric month/day/year (MM/DD/YY)
- Any format familiar to the site
Correct answer: Day, month, year (DD/MMM/YYYY)
ICH E6 GCP recommends the DD/MMM/YYYY format (e.g., 11/JUL/2026) to avoid ambiguity between month and day.
Question 6: In a lactation study CRF, the 'reason for not breastfeeding' field has multiple checkboxes. A participant reports two reasons. How should this be recorded?
- Select only the primary reason
- Check all applicable boxes and document both reasons (Correct answer)
- Leave the field blank and write a note on a separate sheet
- Select the most recent reason only
Correct answer: Check all applicable boxes and document both reasons
When multiple answers apply, all relevant boxes should be checked to capture complete and accurate data.
Question 7: What is the role of a data manager in a lactation clinical study?
- Providing direct breastfeeding support to participants
- Overseeing collection, verification, and cleaning of study data to ensure integrity (Correct answer)
- Recruiting participants for the study
- Conducting statistical analysis of results
Correct answer: Overseeing collection, verification, and cleaning of study data to ensure integrity
The data manager is responsible for ensuring all collected data is complete, accurate, and clean before analysis.
Certified Lactation Specialist Data Collection & CRF Management 3
A mother in a lactation study reports she stopped breastfeeding between two scheduled visits.
How should this be documented in the CRF?