ICH guideline
ICH E6(R3): Good Clinical Practice (GCP)
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E6(R3) |
|---|---|
| Title | Good Clinical Practice (GCP) |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | ICH E6 is an internationally recognised Good Clinical Practice standard for the ethical, scientific and quality conduct of clinical trials involving human participants. In the two decades since ICH E6 was first published, clinical trials have become more complex with respect to trial design, use of technology, quantity… |
| File | E6(R3) Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E6(R3) Work Plan 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.