Generated Narrative: ValueSet adverse-event-clinical-research-seriousness-criteria Profile: Shareable ValueSet Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl Code Display C48275 Results In Death C84266 Is Life Threatening C83052 Requires Inpatient Hospitalization C11338 Results In Persistent Or Significant Disability C83117 Congenital Anomaly or Birth Defect C82521 Other Medically Important Condition C201939 Required Intervention to Prevent Permanent Impairment/damage
Adverse Event Clinical Research Seriousness Criteria
Action criteria usually associated with serious events that pose a threat to a patient's life or functioning. Adverse Events criteria to expand on the seriousness of the adverse event. Typically used in reporting for Clinical Research, post-market surveillance (e.g. Form FDA 3500A MedWatch). The adverse event seriousness criteria value set is based on the ICH E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting guidance (https://database.ich.org/sites/default/files/E2D_Guideline.pdf). For information on ICH see https://admin.ich.org/sites/default/files/inline-files/OID_Information_Paper_1.pdf from the INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) document ICH E2B(R3), the Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide Data Elements and Message Specification, and ICH M8, the Electronic Common Technical Document
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Results In Persistent Or Significant Disability
Required Intervention to Prevent Permanent Impairment/damage