Reference:ICH ICH E19 Guideline 2022 6
From GxPlex
| 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 | |
| Reference Details | |
|---|---|
| Scope | G |
| Document part | 6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Adverse event of special interest (AESI) |
Content
[...] Adverse Event of Special Interest: An event (serious or non-serious) of scientific and medical concern specific to the sponsorâs product or programme, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterise and understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (e.g., regulators) might also be warranted (based on CIOMS VI; see ICH E2F). [...]
