Core Concepts and Principles Flashcards

Which document is considered the 'source document' for a participant's blood pressure reading taken at a study visit?

Answer: The original record where the reading was first written or captured

Source documents are the original records where data are first recorded, from which CRF data are transcribed.

What does the ALCOA principle require of research data?

Answer: Accurate, Legible, Contemporaneous, Original, Attributable

ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate data.

How should an error on a paper source document be corrected under GCP?

Answer: Draw a single line through it, write the correct value, and initial and date the change

Corrections must keep the original entry readable and be initialed and dated to maintain an audit trail.

Which study design follows a group of people over time from exposure to outcome?

Answer: Prospective cohort study

Prospective cohort studies enroll participants by exposure status and follow them forward to observe outcomes.

In a double-blind trial, who is unaware of treatment assignments?

Answer: Both participants and the investigators or assessors

Double-blinding conceals assignments from participants and from those administering or assessing the intervention.

A study has high reliability but low validity. What does this mean?

Answer: The measure consistently gives the same results but does not measure what it is intended to measure

Reliability is consistency, while validity is whether the tool truly measures the intended concept.

Which federal regulation is commonly called the 'Common Rule'?

Answer: 45 CFR 46 Subpart A

The Common Rule is 45 CFR 46 Subpart A, governing federally funded human subjects research.