Reference:ICH ICH E2A Guideline 1994 III E: Difference between revisions
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| | | [[Glossary:TAG-00277-Pla-par|Placebo]], [[Glossary:TAG-00278-Com-ato|Comparator]], [[Glossary:TAG-00252-Exp-hle|Expedited reporting]], [[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 5.3.1 |
| Scope | G |
| Document part | III E |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Placebo, Comparator, Expedited reporting, Sponsor |
| Comment | AEs associated with comparator or placebo treatment |
Content
Miscellaneous Issues 1. Reactions Associated with Active Comparator or Placebo Treatment It is the sponsor's responsibility to decide whether active comparator drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies. Sponsors must report such events to either the manufacturer of the active control or to appropriate regulatory agencies. Events associated with placebo will usually not satisfy the criteria for an ADR and, therefore, for expedited reporting.
