E2A: Clinical Safety Data Management—Definitions and Standards for Expedited Reporting

International Council for Harmonisation. (1994). E2A: Clinical Safety Data Management—Definitions and Standards for Expedited Reporting.

Type

Standard

Intellectual base

Reference work

Year

1994

Link

https://database.ich.org/sites/default/files/E2A_Guideline.pdf

Cited by

1 citation across 1 artifact.

Domain-specific

• Adverse Event Prediction
  • Under ICH E2A, an adverse event is an untoward medical occurrence associated in time with a medicinal product and need not have a causal relationship; an adverse reaction adds at least a reasonable possibility of drug causation.

Verification

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