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).
Unexpected Adverse Drug Reaction
About the Author: Manish Rauthan
This is Manish Rauthan and I am a Clinical Research Professional with Blogger and I am the owner of Clinical Ocean. Clinical Ocean is a blog for all the Clinical Research and Medical Professionals, specially for newbies who want to enter into CR domain. Follow me on twitter: @clinicalocean and Facebook ClinicalOcean