Document:ICH ICH E19 Guideline 2022: Difference between revisions
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Revision as of 15:06, 29 June 2026
| Document information | |
|---|---|
| Reference | ICH ICH E19 Guideline 2022 |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E19 Guideline |
| Version / Revision | 2022 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:ICH ICH E19 Guideline 2022 6 | G | 6 | EN | [...] Adverse Event of Special Interest: An event (serious or non-serious) of scientific and medical concern specific to the sponsor’s product or programme, for which ongoing monitoring and rapid ... |
