ICH guideline
ICH E3: Structure and Content of Clinical Study Reports
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E3 |
|---|---|
| Title | Structure and Content of Clinical Study Reports |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 1995. This document describes the format and content of a clinical study report that will be acceptable to all regulatory authorities of the ICH regions. It consists of a core report suitable for all submissions and appendices that need to be available… |
| File | E3 Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E3 Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.