ICH guideline
ICH E8(R1): General Considerations for Clinical Studies
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E8(R1) |
|---|---|
| Title | General Considerations for Clinical Studies |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This version of the ICH E8 General Considerations for Clinical Studies Guideline was finalised in October 2021 and sets out general principles on the conduct of clinical studies, with the objectives of the document being to: (1) Describe internationally accepted principles and practices in the design and conduct of… |
| File | E8(R1) Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E8(R1) Step 4 Presentation 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.