Data Collection & CRF Management Flashcards

Which ALCOA principle is violated when a lactation consultant fills in a CRF three days after a participant visit without noting the true observation date?

Answer: Contemporaneous

The contemporaneous principle requires data to be recorded at the time of observation; entering it days later without documentation violates this standard.

A lactation study team wants to compare breastfeeding rates across three clinical sites. Which data collection requirement is most important for cross-site comparability?

Answer: Uniform CRF design and standardized definitions across all sites

Uniform CRFs and standardized definitions ensure that data collected at different sites can be meaningfully compared and pooled.

In a pediatric lactation study, informed consent for CRF data use must be obtained from whom?

Answer: The legal guardian or parent, since infants cannot consent for themselves

Because infants cannot provide consent, their parent or legal guardian must provide informed consent for participation and data collection.

A missing value in a lactation CRF is coded as '999'. This is an example of what type of data management convention?

Answer: A missing value code

Missing value codes like '999' are placeholder values that distinguish missing data from true zeros or legitimate responses during analysis.

What is the primary risk of using unvalidated questionnaires to measure breastfeeding self-efficacy in a CRF?

Answer: They may not accurately or consistently measure what they intend to measure

Unvalidated questionnaires lack evidence of reliability and validity, meaning they may not accurately reflect the construct being measured.

A data monitoring committee (DMC) reviews interim lactation study data. Which CRF characteristic most supports their ability to conduct a meaningful review?

Answer: Complete, accurate, and timely data entry by site staff

A DMC can only make sound safety and efficacy decisions when the data available to them is complete, accurate, and up to date.

When a participant withdraws from a lactation study, what should happen to the CRF data already collected?

Answer: Data collected up to withdrawal should be retained per the protocol and regulatory requirements

Data collected prior to withdrawal is typically retained and may be used in analysis, as specified in the protocol and consistent with the original informed consent.