CPI Subject Recruitment, Screening & Retention 3

Question 1

In clinical research, 'lost to follow-up' refers to subjects who:

Accepted Answer

Cannot be contacted or located to complete protocol-required follow-up visits

Answer

'Lost to follow-up' describes enrolled subjects who become unreachable and cannot complete scheduled visits, which must be documented as protocol deviations and reported as required.

Question 2

Who is responsible for reviewing and approving the amount and method of compensation offered to research subjects to ensure it does not constitute undue inducement?

Accepted Answer

The IRB, as part of its review of recruitment and consent procedures

Answer

IRBs review subject compensation as part of consent oversight to ensure payment amounts are reasonable and do not impair the subject's voluntary decision-making.

Question 3

When a subject voluntarily withdraws from a clinical trial, the PI is required to:

Accepted Answer

Document the withdrawal and reason (if provided), and complete protocol-required safety follow-up assessments

Answer

Withdrawal must be documented with the subject's stated reason (if given), and any safety follow-up visits required by the protocol must be completed to protect the subject's well-being.

Question 4

Which of the following recruitment scenarios most clearly constitutes undue inducement?

Accepted Answer

Offering a $5,000 payment to low-income subjects for a two-week minimal-risk study

Answer

A disproportionately large payment, especially to a financially vulnerable population, can impair rational decision-making by making refusal economically unreasonable—the hallmark of undue inducement.

Question 5

To protect subject confidentiality, what is the minimum appropriate information to capture in a subject enrollment log?

Accepted Answer

A unique subject identifier (not personal identifiers) and the date of screening and/or enrollment

Answer

Enrollment logs use unique subject identifiers (not names or SSNs) linked only by a confidential code list held separately, preserving auditability while protecting subject privacy.

(CPI) Certified Principal Investigator Practice Test

(CPI) Certified Principal Investigator Practice Test

CPI Subject Recruitment, Screening & Retention 3