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

Formally withdraw consent and request deletion of their data

Answer

Are transferred to a different investigator at another site

Answer

Fail re-screening after a planned treatment gap

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

The principal investigator alone, as the responsible physician

Answer

The study sponsor, since they control the research budget

Answer

The FDA, through a pre-study review process

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

Make repeated attempts to persuade the subject to remain in the study

Answer

Immediately destroy all data and samples collected from that subject

Answer

Notify the FDA within 24 hours of the subject's withdrawal

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

Providing bus tokens so low-income subjects can travel to clinic visits

Answer

Informing prospective subjects that their participation will help advance medical science

Answer

Reimbursing parking fees incurred during study visits

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

Full legal name, date of birth, and Social Security number

Answer

Subject identifier, date of enrollment, and randomization assignment

Answer

Full contact information and emergency contact details

Question 6

Which federal law specifically mandates the inclusion of women and minorities in NIH-funded clinical research and prohibits their unjustified exclusion?

Accepted Answer

The NIH Revitalization Act of 1993

Answer

FDA Guidance on Good Clinical Practice (ICH E6)

Answer

The HIPAA Privacy Rule (45 CFR Part 164)

Answer

The Belmont Report

Question 7

Before recruitment advertising materials for a clinical trial may be distributed or posted, they must be reviewed and approved by:

Accepted Answer

The IRB, because advertisements are considered part of the informed consent process

Answer

The study sponsor's medical monitor only

Answer

The FDA through a formal pre-screening process

Answer

The PI and co-investigators as the responsible research team