Definition

A critical analysis of clinical safety and efficacy data that integrates information from multiple sources into a coherent summary for regulatory submissions.

Example

The clinical overview in Module 2.5 of a marketing application synthesizes safety data from Phase 1-3 trials, highlighting key risks, their management, and overall benefit-risk conclusions.

Regulatory source

ICH M4E, CTD Format

Common mistakes

Writing overviews that simply repeat study synopses rather than providing integrated critical analysis.

Inspector question

How do you ensure the clinical overview accurately represents all available safety data?

Related terms