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

CDISC requirements to create SDTMs and ADAMs are not easy to understand or apply. There are many rules and standards that must be mastered and maintained across global studies. Pharmaceutical companies and CROs supporting global studies have a need to apply proven methods that reduce confusion and improve documentation. With new members joining the study team, there should be a system to help standardize and automate the FDA submission process.
This webinar will illustrate essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE). Examples of both SDTM and ADaM dataset structures will be reviewed and compared. In addition, a mapping plan from raw datasets to SDTM to ADaM datasets will also be outlined. To help assure higher quality clinical data, a QC checklist and some key edit check macros will be introduced. Attendees will get a copy of the new CDSIC e-guide and all SAS macros reviewed in class.
Learning Objectives:
Utilize metadata to automatically assign variable attributes in SDTMs and ADaMs
Create and process ISO8601 dates, hierarchy of adverse events variables, paired lab variables, as well as lab visit window techniques
Apply effective techniques for using PROC TRANSPOSE to create and merge SUPPXX datasets with SDTMs to create ADAMs
Be better prepared for the SAS Clinical Trials Certification exam
Areas Covered in the Webinar:
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