Reference:ICH ICH E9 Guideline 1998 2.3.1

Document Information

Document information
Reference	ICH ICH E9 Guideline 1998
Validity area	ICH
Scope(s)	HM
Document name	ICH E9 Guideline
Version / Revision	1998
Status	Current
Document type	International guideline
Language(s)	EN
Description	STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	HM
Document part	2.3.1
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Breaking the blind for individual subjects: conditions

Text

[...] Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subject’s physician for the subject’s care. Any intentional or unintentional breaking of the blind should be reported and explained at the end of the trial, irrespective of the reason for its occurrence. The procedure and timing for revealing the treatment assignments should be documented. [...]