Which statement about the Subject Screening Log is true?

• A. To log IP accountability
• B. To identify subjects who entered pre-trial screening
• C. To record visits
• D. To report to FDA

Answer: (B)

The subject screening log is used to track every person who goes through the screening process for eligibility in a trial, recording who entered screening and the outcome (whether they were eligible or not). This creates an audit trail of recruitment and enrollment decisions and helps the study team know who began screening and how far they progressed. It isn’t used for IP accountability, which handles drug supply and usage records, nor for recording visits (that’s done in the visit logs or case report forms), and it isn’t a regulatory reporting tool to the FDA. So identifying subjects who entered pre-trial screening is the correct description.