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

Reference	Scope	Document part	Language	Preview
Reference: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-related (adverse drug reactions), might be ...
Reference: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 note of clarification is provided: The term "severe" ...
Reference: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., Investigator's Brochure for an unapproved ...
Reference: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 sponsor as having a reasonable suspected causal ...
Reference: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 communication to regulatory authorities; appropriate ...
Reference: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. Fatal or Life-Threatening Unexpected ADRs Certain ...
Reference: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 comparator drug reactions should be reported to ...