Document:ICH ICH E2A Guideline 1994

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

References

	Scope	Document part	Language	Preview
ICH ICH E2A Guideline 1994 II A. 3.	G	II A. 3.	EN	Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,…
ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction	G	II B. Serious Adverse Event or Adverse Drug Reaction	EN	Serious Adverse Event or Adverse Drug Reaction During clinical investigations, adverse events may occur which, if suspected to be medicinal product-re…
ICH ICH E2A Guideline 1994 II B. Serious/Severe	G	II B. Serious/Severe	EN	[…] To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," which are not synonymous, the following not…
ICH ICH E2A Guideline 1994 III A. 1.	G	III A. 1.	EN	[...] Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the spon…
ICH ICH E2A Guideline 1994 III A. 2.	G	III A. 2.	EN	2. Other Observations There are situations in addition to single case reports of "serious" adverse events or reactions that may necessitate rapid com…
ICH ICH E2A Guideline 1994 III B. - III C.	G	III B. - III C.	EN	CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING III. STANDARDS FOR EXPEDITED REPORTING B. Reporting Time Frames 1.…
ICH ICH E2A Guideline 1994 III E	G	III E	EN	Miscellaneous Issues 1. Reactions Associated with Active Comparator or Placebo Treatment It is the sponsor's responsibility to decide whether active c…