CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule) 2019

Topics

• SDTM
• 80% General Variables
• Apply One of Seven Mapping Methods
• Mapping to SDTM Variables: Four Types
• Control Terminology – Format Metadata from CODELISTS tab
• Eight Variable Types Based on Values
• AE MedDRA Hierarchy Structure
• SDTM Metadata Excel file
• DM, AE, EX, SE, SV
• Purpose of Trial Designs: Trial Elements, Trial Arms and Trial Visits
• Analysis Variables
• ADaM
• Baseline Identification
• Imputation Methods
• ADSL, ADAE
• Visit Windows and Unscheduled Visits
• SDTM
• 20% Special Variables
• Questionnaire Data
• SUPPDM, SUPPAE, RELREC
• Findings About (FA) – Collection of Different CRFs
• SDTM Oncology Domains (TU, TR, RS)
• ADaM - DTYPE, Other ex. ADVSLT

Who should Attend

• Quality Assurance Specialists
• SAS Statistical Programmers
• Medical Writers
• SAS Statistical Managers
• Regulatory Affairs Associates
• Statisticians
• Directors, Statistical Programming
• Clinical Data Managers
• Health Care Professionals
• CRO Professionals
• Research University Specialists