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Reference:ICH ICH E19 Guideline 2022 6: Difference between revisions

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{{#set:
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|scope=G
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|doc_part=6
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|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
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|contributors=
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|tags=TAG-00045-Adv-hte ++ TAG-00137-Mon-che ++ TAG-00017-Spo-die ++ TAG-00250-Inv-sme
== Document Information ==
|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00250-Inv-sme|Investigator safety reporting]]
{{:Document:ICH ICH E19 Guideline 2022}}
|comment=Adverse event of special interest (AESI)
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|content=[...]
== Reference Details ==
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! scope="row" style="width:200px;" | Scope
| G
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! scope="row" style="width:200px;" | Document part
| 6
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! scope="row" style="width:200px;" | Language
| EN
|-
! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
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! scope="row" style="width:200px;" | Contributors
| Β 
|-
! scope="row" style="width:200px;" | Tags (EN)
| Β 
|-
! scope="row" style="width:200px;" | Tags (original language)
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! scope="row" | Comment
| Adverse event of special interest (AESI)
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== Text ==
[...]
Adverse Event of Special Interest:
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 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).
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 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).
[...]
[...]
}}

Latest revision as of 13:50, 16 July 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


Reference Details
Module Module 5 β€” Unit 5.1.2
Scope G
Document part 6
Language EN
Original entry by Florian Adragna
Contributors
Tags Adverse event, Monitoring, Sponsor, Investigator safety reporting

Content

[...] 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 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). [...]

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