ICH guideline
ICH E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2B(R3) |
|---|---|
| Title | Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | ICH E2B EWG was re-formed to conduct a revision of E2B(R2) Guideline in 2003 and in May 2005 a revised Guideline, E2B(R3), was released for public consultation. The ICH Steering Committee had taken a key decision that technical specifications should no longer be developed solely within ICH, but should be created in… |
| File | E2B(R3) Presentation - SDOs |
| File type | PowerPoint |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E2B(R3) Presentation - SDOs 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.