Reference:ICH ICH E2A Guideline 1994 III A. 2.

Document information
Reference	ICH ICH E2A Guideline 1994
Validity area	ICH
Scope(s)	G
Document name	ICH E2A Guideline
Version / Revision	1994
Status	Current
Document type	International guideline
Language(s)	EN
Description	CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING E2A
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Scope	G
Document part	III A. 2.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Other safety observations beyond single case reports

Content

2. Other Observations

There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid communication to regulatory authorities; appropriate medical and scientific judgement should be applied for each situation. In general, information that might materially influence the benefit-risk assessment of a medicinal product or that would be sufficient to consider changes in medicinal product administration or in the overall conduct of a clinical investigation represents such situations. Examples include:

a. For an "expected," serious ADR, an increase in the rate of occurrence which is judged to be clinically important. b. A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease. c. A major safety finding from a newly completed animal study (such as carcinogenicity).