ICH guideline
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2A |
|---|---|
| Title | Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in October 1994. This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug… |
| File | E2A Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- E2A Guideline Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.