1. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2017 Subject(s): Arrhythmias, Cardiac -- chemically inducedArrhythmias, Cardiac -- diagnosisCardiac Electrophysiology -- methodsCardiac Electrophysiology -- standardsDrug ApprovalElectrocardiography -- standardsLong QT Syndrome -- chemically inducedCardiotoxinsClinical Trials as TopicCongresses as TopicDiagnosis, Computer-AssistedDrug-Related Side Effects and Adverse ReactionsInternational CooperationPharmaceutical Preparations -- administration & dosageReference StandardsResearch DesignSex FactorsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. E6(R2) good clinical practice: integrated addendum to ICH E6(R1) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Clinical Trials as Topic -- ethicsClinical Trials as Topic -- methodsEthics Committees, ResearchInformed ConsentRandomized Controlled Trials as Topic -- ethicsRandomized Controlled Trials as Topic -- methodsResearch DesignResearch SubjectsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
