Reference:ICH ICH E2A Guideline 1994 III A. 1.: Difference between revisions
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| | |RefTags=TAG-00066-Cau-enh ++ TAG-00003-Adv-cht ++ TAG-00297-Ind-erh ++ TAG-00201-Cli-eSt ++ TAG-00017-Spo-die | ||
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| | | [[Glossary:TAG-00066-Cau-enh|Causality]], [[Glossary:TAG-00003-Adv-cht|Adverse reaction]], [[Glossary:TAG-00297-Ind-erh|ICSR]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]], [[Glossary:TAG-00017-Spo-die|Sponsor]] | ||
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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. 1. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Causality, Adverse reaction, ICSR, Clinical investigation, Sponsor |
| Comment | Causality assessment in clinical investigation cases |
Content
[...] Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as ADRs. For purposes of reporting, adverse event reports associated with marketed drugs (spontaneous reports) usually imply causality. [...]
