Features of this course

CDISC Training teaches programmers essential concepts about creating and validating SDTM (v 3.4 IG) and ADaM (v 1.2 IG) variables in key CDISC datasets (DM, AE, LB, ADSL, ADAE, and ADLB). Attendees learn how to create and process ISO8601 dates, hierarchy of adverse events variables and paired lab variables. Examples of both SDTM and ADaM dataset structures will be reviewed and compared. To help assure higher quality clinical data, a QC checklist will also be introduced.

Program Outline

• CDISC overview
• SDTM overview – Part I and Part II
• ADaM introduction
• SDTM & ADaM Assignments
• CRF Annotation
• SDTM- Mapping specs creation
• SDTM- Dataset Development
• SDTM- Dataset Validation
• ADaM- Mapping specs creation
• ADaM- Dataset Development

Who can take up this Program?

Candidates from the following background are welcome

• Statistical Programmers
• Life Sciences (M.Pharmacy, B.Pharmacy, M.Sc.)
• Statistics (B.Sc., M.Sc.)
• B.E / B.Tech (Biotechnology, Bioinformatics, Computer Science)
• MBBS, BDS, BHMS, and BAMS