Core Concepts and Principles Flashcards

Which Belmont Report principle is most directly applied when a research assistant ensures participants are selected fairly rather than only from convenient vulnerable groups?

Answer: Justice

Justice requires a fair distribution of the burdens and benefits of research, including equitable participant selection.

A participant tells a research assistant midway through a study visit that they want to stop. What is the correct response?

Answer: Respect the decision and follow the protocol's withdrawal procedures

Participants may withdraw at any time without penalty, and staff must follow the protocol's withdrawal process.

In a study testing whether a new tutoring method improves test scores, the test score is the:

Answer: Dependent variable

The dependent variable is the outcome measured to see whether it changes in response to the intervention.

Which situation best describes a confounding variable?

Answer: A factor associated with both the exposure and the outcome that distorts their apparent relationship

A confounder is linked to both exposure and outcome, creating a misleading association if not controlled.

What is the primary purpose of randomization in a clinical trial?

Answer: To balance known and unknown confounders across groups

Random assignment distributes both measured and unmeasured characteristics evenly between groups, reducing selection bias.

Under ICH E6 Good Clinical Practice, who holds ultimate responsibility for the conduct of a trial at a study site?

Answer: The principal investigator

The PI is responsible for the conduct of the trial at the site, even when tasks are delegated to qualified staff.

A research assistant notices a data entry value of 450 for a participant's age. What is the best first step?

Answer: Verify the value against the source document and query or correct per SOPs

Discrepancies should be checked against source documentation and resolved through the documented query/correction process.