Which element defines how safety data are collected and reported?

• A. Procedures for eliciting reports of adverse events and intercurrent illnesses
• B. The type and duration of the follow-up after adverse events
• C. A description of the statistical methods including planned interim analysis
• D. The number of enrolled subjects

Answer: (B)

The type and duration of follow-up after adverse events defines how safety data are collected and reported. When you specify how long you will monitor a participant after an event, and what information you will gather during that period (outcome, resolution, any ongoing effects, additional tests, actions taken), you establish the exact data collection schedule and the timing of safety reports. This follow-up plan ensures you capture complete, reliable information about each event and its outcome, which is essential for accurate safety assessment and regulatory reporting.

Procedures for eliciting reports influence how events are discovered but don’t by themselves set the time frame and depth of data collection after an event. The description of statistical methods speaks to analysis plans, not how data are gathered. The number of enrolled subjects affects study power and scope, not the method or duration of safety data collection.