Reference:ICH ICH E2A Guideline 1994 III A. 2.: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:ICH ICH E2A Guideline 1994 | ||
| | |module=5 | ||
| | |unit=5.1.4 | ||
| | |scope=G | ||
| | |doc_part=III A. 2. | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00329-Saf-lne ++ TAG-00046-Ser-sSc ++ TAG-00252-Exp-hle ++ TAG-00327-Exa-spi | |||
|tags_display=[[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]] | |||
|comment=Other safety observations beyond single case reports | |||
|content=2. Other Observations | |||
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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: | 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: | ||
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b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease. | 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). | c. A major safety finding from a newly completed animal study (such as carcinogenicity). | ||
}} | |||
Latest revision as of 13:50, 16 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 |
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).
