Which document identifies subjects who entered pre-trial screening?

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

Answer: (A)

In a clinical trial, tracking who actually enters the screening phase is essential for transparency and recruitment oversight. The document that identifies subjects who entered pre-trial screening is the screening log (often called a pre-screening log). It lists every potential participant who begins screening, along with their screening status and any reasons for screen failure. This creates an auditable flow from screening toward enrollment and helps prevent duplicate contact or enrollment, while also showing who was considered for the study.

The other documents serve different purposes: IP accountability tracks the investigational product from receipt through dispensation and return; a visit log records the actual study visits that occur; and an adverse events log captures safety events. None of these specifically identifies individuals who entered the pre-trial screening stage.