CDISC - SDTM and ADaM

Duration

45 days

Topics Covered

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

Practical Training

Practical exposure to 6 SDTM & ADaM projects. These assignments are designed to reinforce your learning through practical experience. This skill will help you to tackle the uncertainties that are invariably part of the live projects.

Batch Size

10 students per batch

Eligibility:

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

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.

Mode of Training

Virtual Classroom and Classroom

Mode of Payment

Payment can be done by Payment gateway/Online Transfer