View source for Document:ICH ICH E19 Guideline 2022

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|DocDescription=A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS
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|reference=ICH  ICH E19 Guideline  2022
|validity_area=ICH
|scopes=G
|doc_name=ICH E19 Guideline
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|status=Current
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|language=EN
|description=A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS
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== References ==
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| [[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>