unexpected adverse drug reaction
- Guideline or reference source
- ICHE6(r1) Guideline for good clinical practice
- Definition
- 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 investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
- Broader Term
- adverse drug reaction
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