SESSION 2:FUNDAMENTALS OF QUALITY COMPLIANCE OF CLINICAL TRIALS: QC/QA ELEMENTS AND QMSInstitute of Executive Development State Food and Drug Administration of ChinaTraining Program of Clinical Trial Management in Medical Device DevelopmentNanjing, ChinaSeptember 28-29, 2012Mary Ann MorrisAssociate ConsultantGlobal Medical Quality,Eli Lilly & Company, United States第二部分:临床试验质量依从性的基础: QA/QC要素和质量管理体系 The goal of quality in clinical research is to ensure the collection of data in integrity in an eth