CDISC Standards Strategy & Metadata
Choose and connect the standards before building datasets
Design a governed CDISC implementation from collection through tabulation, analysis metadata and submission documentation.
Study blueprint, source inventory and corporate standards
Approved standards plan, metadata model and implementation conventions
Real course content
6 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
Why standards — the CDISC ecosystem
The problem CDISC solves, the standards family (CDASH → SDTM → ADaM → define), the wider ecosystem (SEND, CT, TAUGs), the regulatory mandate, and the transport formats.
Chapter 1 of 6
CDASH — the collection standard
Collection vs tabulation, CDASH domains and variables, how CDASH shapes the CRF, and the path to SDTM.
Chapter 2 of 6
The SDTM model
The structure of tabulation data: observation classes, special-purpose domains, variable roles, CORE status, value-level metadata, and the general assumptions.
Chapter 3 of 6
The ADaM model
Analysis-ready, traceable data: ADaM vs SDTM, fundamental principles, data-point traceability, the ADSL/BDS/OCCDS structures, standard variables, and the three metadata layers.
Chapter 4 of 6
Controlled terminology
CDISC CT and codelists, MedDRA for events, WHODrug for meds, LOINC/UNII, and versioning.
Chapter 5 of 6
define.xml & the data package
What define.xml is, its metadata layers, reviewer’s guides, and how define ties the package together.
Chapter 6 of 6