MedDRA - 第二军医大学卫生统计学教研室.pptVIP

AE/SAE Reporting and Coding;AE/SAE reporting;AE/SAE Reporting;What is AE?;What is AE?(Cont.);ADR (Adverse Drug Reaction );Why collect AE?;;AE collection form (example);;;AE Term;Grade of AE;Relationship with AE;Relationship with AE;Relationship with AE;Relationship options;Study medication adjustment;Outcome and resolve date;Exercise;SAE?;SAE reporting;SAE reporting to sponsor;AE/SAE Analysis;AE/SAE analysis;;;SAE reconciliation;Purpose of SAE reconciliation;SAE reconciliation process;SAE reconciliation;Coding Overview;Why?;Why Do Medical and Drug Terms Need to Be Classified?;What?;How?;When are terms manually classified?;Coding Discrepancy;Classification Process(AE term);MedDRA Dictionary;Outline of this Session; ;History of MedDRA;History of MedDRA (cont.);History of MedDRA (cont.);Early 1999: Services and distribution begin (with v2.0) Each MedDRA term receives an unique 8-digit numeric code to facilitate electronic transmission. This is sequential without inherent meaning ;Scope of MedDRA;MedDRA Structure;;Basic Structure Example;Terminology;Analysis Reporting Terms;Query Terms;Coding Terms;The 26 MedDRA SOCs;;Multiaxiality;Simple Multiaxial Mapping;HLGT Diabetic complications;;Hierarchy (V9.0);What is new in MedDRA?; ;;