CDISC standards: A challenge

The documentation for the standards is vast, spanning thousands of pages. Here are the main documents:

  • SDTM & SDTM-IG
  • ADaM & ADaM-IG
  • Define-XML
  • Controlled Terminology
  • Standards by therapeutic area
  • Questionnaires guides
  • Specific ADaM documents (TTE, PK, etc.)
  • Standards for metadata submission
  • Standards for reviewer guides
  • Compliance rules
  • FDA Technical Compliance Guide

Realistic and effective training sessions

Classroom

It is out of the question to master all this documentation in just a few hours of training. As a result, AdClin offers two training sessions:

  • SDTM standard training (8 hours)
  • ADaM standard training (7 hours)

Each training session provides an overview of the available documentation, followed by a detailed presentation of the current version of the implementation guide. The course materials follow the structure of the documents' table of contents, allowing trainees to:

  • Gain an overall understanding of each topic, supported by examples from AdClin's experience, particularly for challenging cases ;
  • Have a reference to further explore specific points by returning to the original documentation.