CPI Subject Recruitment, Screening & Retention 1 — Questions and Answers
Question 1: What is the primary purpose of a screening log in clinical research?
- To track all individuals evaluated for study eligibility, including screen failures (Correct answer)
- To record randomization assignments for enrolled subjects
- To document adverse events that occur during the screening period
- To list all protocol amendments approved by the IRB
Correct 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.
Question 2: Which document establishes the inclusion and exclusion criteria that determine a subject's eligibility for a clinical trial?
- The investigator brochure
- The informed consent form
- The study protocol (Correct answer)
- The delegation of authority log
Correct answer: The study protocol
The study protocol contains the specific inclusion and exclusion criteria that define who is eligible to participate in the trial.
Question 3: According to FDA regulations, when a subject fails screening, what documentation is the PI required to maintain?
- Only the subject's initials and the screening date
- The subject's full name and reason for failure
- Sufficient information to audit the screening process, including the reason for failure (Correct answer)
- No documentation is required for screen failures under FDA regulations
Correct 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.
Question 4: 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:
- Randomization
- Stratification
- Eligibility assessment (Correct answer)
- Baseline evaluation
Correct 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.
Question 5: Which federal regulation requires that the selection of research subjects be equitable and give appropriate consideration to vulnerable populations?
- 21 CFR Part 50
- 45 CFR Part 46 (The Common Rule) (Correct answer)
- 21 CFR Part 312
- 45 CFR Part 164 (HIPAA Privacy Rule)
Correct 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.
Question 6: Which of the following subject retention strategies is considered ethically acceptable in a long-term clinical trial?
- Paying subjects a substantially higher bonus if they complete the final study visit
- Providing reasonable reimbursement for travel and time at each scheduled visit (Correct answer)
- Contacting subjects' employers to arrange time off for study appointments
- Withholding interim laboratory results unless the subject agrees to continue participating
Correct 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.
Question 7: Before enrolling a subject from a vulnerable population such as prisoners, the PI must ensure that:
- The subject has completed at least one prior research study
- The IRB-required additional safeguards for that population are in place (Correct answer)
- The study sponsor has issued written approval to include this subject
- The subject holds a higher level of education than the general study population
Correct 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.
CPI Subject Recruitment, Screening & Retention 1
What is the primary purpose of a screening log in clinical research?