Reference:ICH ICH E2A Guideline 1994 III A. 2.: Difference between revisions
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| | | [[Glossary:TAG-00329-Saf-lne|Safety]], [[Glossary:TAG-00046-Ser-sSc|Serious adverse event]], [[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[Glossary:TAG-00327-Exa-spi|Examples]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | ICH ICH E2A Guideline 1994 |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E2A Guideline |
| Version / Revision | 1994 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
E2A |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 — Unit 5.1.4 |
| Scope | G |
| Document part | III A. 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Safety, Serious adverse event, Expedited reporting, Examples |
| Comment | Other safety observations beyond single case reports |
Content
2. Other Observations
There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate medical and scientific judgement should be applied for each situation. In general, information that might materially influence the benefit-risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such situations. Examples include:
a. For an "expected," serious ADR, an increase in the rate of occurrence which is judged to be clinically important. b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease. c. A major safety finding from a newly completed animal study (such as carcinogenicity).
