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