Generated Narrative: ValueSet adverse-event-clinical-research-causality-relatedness Profile: Shareable ValueSet Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version ∅ Code Display C53256 Not Related C53257 Unlikely Related C53258 Possibly Related C53260 Related
Adverse Event Clinical Research Causality Relatedness
Value set for stating if a suspected entity is Not Related, Unlikely Related, Possibly Related, or Related to the cause of the adverse event. Using NCI codes. The values originate with ICH. 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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