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

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