Document:ICH ICH E2A Guideline 1994
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| 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… |
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 ... |
