MedDRA TERM SELECTION.doc

文档介绍：MedDRA®TERMSELECTION:POINTSTOCONSIDERICH-©CopyrightICHSecretariat(c/oIFPMA)Copyingispermitted,withreferencetosource,butmaterialinthispublicationmaynotbeusedinanydocumentationorelectronicmediawhichisofferedforsale,-Dunant,:[phone]Fax:[phone]leofContentsSection1–INTRODUCTION –ObjectivesofthisDocument –UsesofMedDRA –HowtoUsethisDocument –PreferredOption –MedDRABrowsingTools 2Section2–GENERALTERMSELECTIONPRINCIPLES –QualityofSourceData –QualityAssurance –DoNotAlterMedDRA –AlwaysSelectaLowestLevelTerm –SelectOnlyCurrentLowestLevelTerms –WhentoRequestaTerm –UseofMedicalJudgmentinTermSelection –erm –ChecktheHierarchy –SelectTermsforAllReportedInformation,DoNotAddInformation 6Section3–TERMSELECTIONPOINTS –DefinitiveandProvisionalDiagnoseswithorwithoutSignsandSymptoms –es (non-fatal) –SuicideandSelf-Harm -injuryisreported –Conflicting/Ambiguous/VagueInformation “split”intomorethanoneMedDRAterm -existingcondition – – –