Certified Lactation Specialist Data Collection & CRF Management 3

Question 1

A mother in a lactation study reports she stopped breastfeeding between two scheduled visits. How should this be documented in the CRF?

Accepted Answer

Record it as a protocol deviation and note the cessation date

Answer

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?

Accepted Answer

To reduce transcription errors by comparing two independently entered datasets

Answer

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?

Accepted Answer

Volume of expressed breast milk in milliliters

Answer

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?

Accepted Answer

All data entries, modifications, deletions, and the user who made them with timestamps

Answer

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?

Accepted Answer

Day, month, year (DD/MMM/YYYY)

Answer

ICH E6 GCP recommends the DD/MMM/YYYY format (e.g., 11/JUL/2026) to avoid ambiguity between month and day.

Certified Lactation Specialist Practice Test