Subject Recruitment, Screening & Retention Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Subject Recruitment, Screening & Retention flashcards as text
What is the primary purpose of a screening log in clinical research?
Answer: To track all individuals evaluated for study eligibility, including screen failures
A screening log documents every individual evaluated for participation, including those who failed screening, providing a complete and auditable account of subject selection.
Which document establishes the inclusion and exclusion criteria that determine a subject's eligibility for a clinical trial?
Answer: The study protocol
The study protocol contains the specific inclusion and exclusion criteria that define who is eligible to participate in the trial.
According to FDA regulations, when a subject fails screening, what documentation is the PI required to maintain?
Answer: Sufficient information to audit the screening process, including the reason for failure
FDA regulations require investigators to maintain adequate records to reconstruct the study, including screen failure documentation with reasons to demonstrate protocol adherence.
The systematic process of verifying that a prospective participant satisfies all protocol-defined inclusion criteria and none of the exclusion criteria before enrollment is called:
Answer: Eligibility assessment
Eligibility assessment is the structured evaluation process confirming that a prospective subject meets all protocol criteria before they can be formally enrolled.
Which federal regulation requires that the selection of research subjects be equitable and give appropriate consideration to vulnerable populations?
Answer: 45 CFR Part 46 (The Common Rule)
45 CFR 46.111(a)(3), the Common Rule, requires IRBs to verify that subject selection is equitable and that vulnerable populations are not unfairly burdened or excluded.
Which of the following subject retention strategies is considered ethically acceptable in a long-term clinical trial?
Answer: Providing reasonable reimbursement for travel and time at each scheduled visit
Reasonable, visit-based reimbursement for time and travel is ethically acceptable because it compensates participants proportionally without creating undue pressure to remain in the study.
Before enrolling a subject from a vulnerable population such as prisoners, the PI must ensure that:
Answer: The IRB-required additional safeguards for that population are in place
Federal regulations (45 CFR Part 46 Subparts B–D) require additional protections for vulnerable populations, and the IRB must approve those safeguards before enrollment proceeds.