A practicum that offers specialized knowledge and skills about CDISC standards. You get the guidance required to start your journey of exploring the CDISC standards and a chance to complete the relevant assignments that complement the theoretical knowledge.

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.

Tools Used

SAS® 9.4 License version software

Batch Size

10 students per batch

Eligibility

Candidates should be trained in SAS® with following educational qualification (preferably).

  • Life sciences (M.Pharm., B.Pharm., M.Sc.)
  • Statistics (B.Sc., M.Sc.)
  • BE /BTech (Biotechnology,Bioinformatics,Computer Science)
  • MBBS, BDS, BHMS and BAMS

Features of the Course

CDISC Training teaches SAS programmers essential concepts about creating and validating SDTM (v 3.1.2 IG) and ADaM (v 1.0 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.