CPI Subject Recruitment, Screening & Retention

Question 1

What is the primary purpose of a screening log in clinical research?

Accepted Answer

To track all individuals evaluated for study eligibility, including screen failures

Answer

To record randomization assignments for enrolled subjects

Answer

To document adverse events that occur during the screening period

Answer

To list all protocol amendments approved by the IRB

Question 2

Which document establishes the inclusion and exclusion criteria that determine a subject's eligibility for a clinical trial?

Accepted Answer

The study protocol

Answer

The investigator brochure

Answer

The informed consent form

Answer

The delegation of authority log

Question 3

According to FDA regulations, when a subject fails screening, what documentation is the PI required to maintain?

Accepted Answer

Sufficient information to audit the screening process, including the reason for failure

Answer

Only the subject's initials and the screening date

Answer

The subject's full name and reason for failure

Answer

No documentation is required for screen failures under FDA regulations

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:

Accepted Answer

Eligibility assessment

Answer

Randomization

Answer

Stratification

Answer

Baseline evaluation

Question 5

Which federal regulation requires that the selection of research subjects be equitable and give appropriate consideration to vulnerable populations?

Accepted Answer

45 CFR Part 46 (The Common Rule)

Answer

21 CFR Part 50

Answer

21 CFR Part 312

Answer

45 CFR Part 164 (HIPAA Privacy Rule)

Question 6

Which of the following subject retention strategies is considered ethically acceptable in a long-term clinical trial?

Accepted Answer

Providing reasonable reimbursement for travel and time at each scheduled visit

Answer

Paying subjects a substantially higher bonus if they complete the final study visit

Answer

Contacting subjects' employers to arrange time off for study appointments

Answer

Withholding interim laboratory results unless the subject agrees to continue participating

Question 7

Before enrolling a subject from a vulnerable population such as prisoners, the PI must ensure that:

Accepted Answer

The IRB-required additional safeguards for that population are in place

Answer

The subject has completed at least one prior research study

Answer

The study sponsor has issued written approval to include this subject

Answer

The subject holds a higher level of education than the general study population