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Document:ICH ICH E19 Guideline 2022: Difference between revisions

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== References ==
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! 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 ...
|}
</noinclude>

Latest revision as of 14:15, 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

References

 ScopeDocument partLanguagePreview
ICH ICH E19 Guideline 2022 6G6EN[...]

Adverse Event of Special Interest:

An event (serious or non-serious) of scientific and medical concern specific to the sponsor’s product or prog…
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