Definition

Safety data from the period between the previous and current data lock points, representing new information since the last report.

Example

Interval data for the annual PSUR shows 3,500 new cases reported between January 1 and December 31, compared to 3,200 in the previous interval.

Regulatory source

ICH E2C(R2)

Common mistakes

Including cumulative data when interval data is required, or vice versa.

Inspector question

How do you generate interval-specific data? How do you track period-over-period changes?

Related terms