CDISC STANDARDISATION & TRAINING


Off-the shelf training courses are currently available for:

Fundamentals of Clinical Trials
An introduction to the fundamentals of clinical trials, including (but not limited to):
  • Drug development
  • Trial design
  • Important documents
  • Data management
  • Statistical programming
  • Statistical analysis
  • Guidelines
CDISC SDTM
An introduction to CDISC SDTM data standards and related topics, including (but not limited to):
  • CDISC overview including CDASH
  • CRF annotation
  • SDTM fundamentals and domains
  • From source to SDTM: step-by-step
CDISC ADaM
An introduction to CDISC ADaM data standards and related topics:
  • Introduction to ADaM
  • ADaM basics and general conventions
  • Fundamentals and purpose of the main ADaM data structures
CDISC Define-XML + S/ADRG
An introduction to CDISC Define-XML (CRT-DDS) and the Study/Analysis Reviewers Guide, including:
  • Introduction to XML
  • Define-XML for SDTM and ADaM
  • Generating and validating Define-XML
  • Walkthrough for SDRG and ADRG
Programming
An in-depth and hands-on training in SAS programming using SAS Studio including (but not limited to):
  • Reading data from various sources
  • Data mapping and conversion:
    - SDTM and ADaM specific derivations (baseline flag, treatment flags, missing data imputation, double or triplicate measurements, unit conversion, length limitation)
  • Edit checks and consistency checks
  • Producing output:
    - Tables, Listings, Figures
    - Output formats and templates
    - Basis statistical procedures
  • Advanced programming techniques
Validation Essentials
An introduction and hands-on training in the basic concepts of validation, including (but not limited to):
  • Development, Validation, Production
  • Peer review and double programming
  • Title 21 CFR Part 11
We can also develop a bespoke training tailored to your needs.