Data Collection & CRF Management Flashcards

When a data entry error is discovered in a paper CRF, what is the correct procedure?

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.

Which type of data is BEST captured using a Likert scale in a lactation research CRF?

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.

In a lactation clinical trial, 'source data' refers to which of the following?

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.

A lactation consultant is collecting data on breastfeeding frequency. What is the most appropriate interval for recall accuracy?

Answer: Previous 24 hours

A 24-hour recall period minimizes memory bias and is considered the standard for feeding frequency data in infants.

Which of the following best describes a query in electronic data capture (EDC) systems?

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.

When is it appropriate to leave a CRF field blank in a lactation study?

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.

Which principle of good clinical data management ensures that data can be attributed to its originator?

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.