Document:ICH ICH E19 Guideline 2022

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 ...