Module 2.5 (Clinical Overview) & Module 2.7 (Clinical Summary)

Common Technical Document module section 2.5 contains the Clinical Overview which is an accurate and exhaustive description of the evidence development plan. It contains the product development rationale, overview of biopharmaceutics, clinical pharmacology, efficacy, safety, benefit/risk conclusions, and literature references.  The evidence development plan lists the completed, ongoing and planned studies by their study ID (which may or may not correspond to a register identifier). It is an invaluable overview and is relatively short (around 30 pages), and is complemented by Module 2.7, the Clinical Summary, which provides more detail of the same data (in around 50 to 400 pages), including the Summary of Clinical Efficacy (section 2.7.3) and Summary of Clinical Safety (section 2.7.4).